xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06005610</url>
    </required_header>
    <id_info>
      <org_study_id>A5403</org_study_id>
      <secondary_id>38806</secondary_id>
      <nct_id>NCT06005610</nct_id>
    </id_info>
    <brief_title>Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy</brief_title>
    <acronym>GET IT RIgHT</acronym>
    <official_title>Giving Standardized Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
        <agency_class>NIH</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Transgender women (TW) are a key population and priority for HIV treatment. More research is&#xD;
        needed to develop evidence-based clinical guidance when it comes to choosing antiretroviral&#xD;
        treatment (ART) regimens for TW on feminizing hormonal therapy (FHT). Concerns about ART&#xD;
        interacting with FHT and decreasing its effectiveness can lead to decreased ART adherence and&#xD;
        increased viral loads.&#xD;
  &#xD;
        The GET IT RiGHT trial aims to address concerns about drug-drug interactions (DDIs) between&#xD;
        ART and FHT while providing access to hormonal therapy to TW living with HIV. Data suggest&#xD;
        that access to FHT improves adherence to HIV treatment and decreases treatment interruptions.&#xD;
  &#xD;
        This is an open-label, non-randomized, 3-group trial of adult TW and other individuals&#xD;
        identifying as female or transfeminine but with male sex assigned at birth living with HIV.&#xD;
        Participants will be on ART at entry and receive study-supplied 17-β estradiol for FHT for 48&#xD;
        weeks.&#xD;
  &#xD;
        The primary objectives of the study are to 1) assess whether TW continue to achieve&#xD;
        therapeutic concentrations of ART while receiving FHT for 48 weeks and 2) assess whether&#xD;
        serum estradiol concentrations on FHT (across a range of estradiol doses) vary between&#xD;
        boosted and un-boosted ART regimens.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A5403 is a phase IIb, 48-week, open-label, non-randomized, 3-group trial, of 90 adult (≥18&#xD;
        years) transgender women and other individuals identifying as female or transfeminine but&#xD;
        with male sex assigned at birth (TW) living with HIV on suppressive antiretroviral therapy&#xD;
        (ART) and not currently on FHT. The trial will target at least 50% enrollment of participants&#xD;
        identifying as non-white or Latine.&#xD;
  &#xD;
        The trial consists of three groups, a BIC-treated group (BIC/TAF/FTC; n=30) (Group 1), a&#xD;
        DTG-treated group (DTG/TDF/FTC or 3TC; n=30) (Group 2), and a boosted DRV-treated group&#xD;
        (DRV/c; n=30) (Group 3), for a total of 90 participants.&#xD;
  &#xD;
        All participants will continue on ART (not provided by the trial) and receive study-supplied&#xD;
        17-β estradiol for weeks 0-48. At entry, participants will be assigned to one of the three&#xD;
        analysis groups based on their current ART regimen. Participants on other ART regimens at&#xD;
        screening who are willing to switch to one of the regimens above, may also be enrolled.&#xD;
  &#xD;
        All participants will receive study supplied 17-β estradiol for weeks 0-48. Oral 17-β&#xD;
        estradiol 2 mg once daily will be initiated at study entry. At weeks 4, 12, 24, and 36, study&#xD;
        clinicians may titrate 17-β estradiol in 2 mg increments as described in the protocol.&#xD;
  &#xD;
        Intensive PK subgroup (n=15 per ART group): At entry (week 0), an 8-hour intensive PK&#xD;
        sampling will assess ART exposure prior to FHT initiation. At week 24, intensive sampling&#xD;
        will be repeated to assess 17-β estradiol and ART exposure. A final intensive PK visit will&#xD;
        occur at week 48 to assess 17-β estradiol and ART exposure at the maximal FHT dosing achieved&#xD;
        during the study period.&#xD;
  &#xD;
        Sparse PK sampling: all participants not participating in an intensive PK sampling visit on&#xD;
        the same day will have timed, sparse PK sampling collected at each visit to characterize the&#xD;
        trough plasma (BIC, DTG, and DRV) and intracellular ART (TFV-DP, FTC-TP, 3TC-TP)&#xD;
        concentrations to evaluate the relationship of ART PK exposure across a range of 17-β&#xD;
        estradiol doses.&#xD;
  &#xD;
        FHT satisfaction and acceptability:&#xD;
  &#xD;
        To measure acceptability, participants will be asked to self-report the degree to which they&#xD;
        find the intervention appropriate and useful using Likert-type agreement scales at three&#xD;
        study time points: entry, 24 weeks, and 48 weeks. To measure satisfaction, the 12-question&#xD;
        Transgender Congruence Scale (TCS) will be used, which will assess associations between&#xD;
        gender-affirming treatments, perceived gender congruence, and satisfaction at three study&#xD;
        time points: entry, 24 weeks, and 48 weeks. In addition, brief, 20-minute, semi-structured&#xD;
        interviews will be conducted with 30 purposively sampled participants across English- or&#xD;
        Spanish-speaking sites to provide an opportunity for more in-depth (open-ended) feedback on&#xD;
        intervention satisfaction and acceptability at three time points: entry, 24 weeks, and 48&#xD;
        weeks.&#xD;
  &#xD;
        Other assessments throughout the study include: anthropometric measurements (including&#xD;
        weight, height, minimum waist circumference, and maximum hip circumference), routine&#xD;
        chemistry and hematology labs, HIV-1 RNA, CD4+ and CD8+ T cell counts and percentages,&#xD;
        lipids, glucose and insulin, non-estradiol hormone concentrations, stored PBMC, plasma, and&#xD;
        serum, and ART and FHT adherence assessments.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 6, 2023</start_date>
    <completion_date type="Anticipated">May 8, 2027</completion_date>
    <primary_completion_date type="Anticipated">May 8, 2027</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Geometric Mean Ratio of ART Analytes BIC, DTG, and DRV trough concentrations (Ctrough) in plasma at each received dose of oral 17-β estradiol</measure>
      <time_frame>Study Entry and Weeks 4, 12, 24, 36, and 48</time_frame>
      <description>Log-transformed trough concentrations (Ctrough) in ng/mL of the analytes BIC, DTG, and DRV from plasma samples collected 22-26 hours post ART dose, measured over 48 weeks.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of Participants with ART Analyte trough concentration (Ctrough) above drug-specific threshold</measure>
      <time_frame>Study Entry and Weeks 4, 12, 24, 36, and 48</time_frame>
      <description>Trough concentration of the analytes BIC, DTG, and DRV in plasma at each received dose of 17-β estradiol summarized at the participant level as indicator of concentration being above drug-specific threshold.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trough serum total estradiol assessed at each received dose of oral 17-β estradiol as quantified via batch testing at central lab.</measure>
      <time_frame>Study Entry and Weeks 4, 12, 24, 36, and 48</time_frame>
      <description>Trough concentrations of Total 17-β estradiol in ng/mL from serum samples collected 22-26 hours post 17-β estradiol dose. Results &lt; Lower Limit of Quantification (LLoQ) at entry will be imputed as 0 ng/mL at one-half the LLoQ value at visits post-entry.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Trough concentrations of TFV-DP, FTC-TP, and 3TC-TP in non-viable PBMCs at each received dose of oral 17-β estradiol</measure>
      <time_frame>Study Entry and Weeks 4, 12, 24, 36 and 48</time_frame>
      <description>Intra-person geometric ratios of trough ART concentration at each received estradiol dose relative to pre-FHT (i.e., baseline).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with TFV-DP, FTC-TP, and 3TC-TP trough concentration above drug-specific threshold</measure>
      <time_frame>Study Entry and Weeks 4, 12, 24, 36 and 48</time_frame>
      <description>Trough concentration of the analytes TFV-DP, FTC-TP, and 3TC-TP in non-viable PBMCs at each received dose of 17-β estradiol summarized at the participant level as indicator of concentration being above drug-specific externally defined threshold.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with an occurrence of any reportable adverse event related to 17-β estradiol</measure>
      <time_frame>Study entry to Week 48</time_frame>
      <description>The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017, and the DAIDS EAE Manual Version 2.0 will be used.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with an occurrence of SAEs as defined by International Conference on Harmonization (ICH) and new events of CAD/CVD, cancer, DM/pre-DM, and vascular event</measure>
      <time_frame>Study entry to Week 48</time_frame>
      <description>Post-entry and while on study treatment, all signs (including an abnormal laboratory finding), symptoms, or diagnoses new in onset or aggravated in severity or frequency from the baseline condition, indicated as related to 17-β estradiol by the site (or the CMC if adjudication differs from that of the site investigator).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with serum total testosterone &lt; 50 ng/dL at each received dose of oral 17-β estradiol</measure>
      <time_frame>Study entry and Weeks 4, 12, 24, 36, 48</time_frame>
      <description>Results &lt; LLoQ will be considered to be &lt;50 ng/dL. If multiple observations are available at the same estradiol dose, the last testosterone concentration (based on calendar time) taken will be used.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with virologic suppression of HIV</measure>
      <time_frame>Study entry and weeks 12, 24, 36, and 48</time_frame>
      <description>Virologic suppression of HIV is defined as plasma HIV-1 viral load &lt;50 copies/mL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute changes in overall transgender congruence score</measure>
      <time_frame>Study entry and weeks 24, and 48</time_frame>
      <description>The overall transgender congruence score is calculated from participant response to the 12-question Transgender Congruence Scale (TCS). Participants rate each item on a 5-point Likert-type scale (i.e., 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree nor disagree, 4 = somewhat agree, 5 = strongly agree). Questions 'The way my body currently looks does not represent my gender identity.', 'I do not feel that my appearance reflects my gender identity.', and 'I am not proud of my gender identity.' are reversed scored. The overall score is the average of the response to the 12 questions, with higher scores indicating a higher level of congruence. Positive changes from baseline indicate improvement in transgender congruence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the curve over 8 hours (AUC 0-8h) of 17-β estradiol</measure>
      <time_frame>Study entry and Weeks 24, and 48</time_frame>
      <description>From pre-dose, 1, 2, 3, 4, 6, and 8 hours post dosing at entry and weeks 24 and 48.&#xD;
  The AUC will use the linear up/log down version of the trapezoidal rule in non-compartmental analysis using Phoenix WinNonLin (Certara®). This version of the trapezoidal rule uses linear interpolation between untransformed data up to Cmax, and between log-transformed data from Cmax through Clast.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent change in weight</measure>
      <time_frame>Study entry and weeks 12, 24, 36, and 48</time_frame>
      <description>Calculated by dividing weight at later time point minus weight at study entry by weight at study entry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent change in BMI</measure>
      <time_frame>Study entry and weeks 12, 24, 36, and 48</time_frame>
      <description>Calculated by dividing BMI at later time point minus BMI at study entry by BMI at study entry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute change in minimum waist circumference</measure>
      <time_frame>Study entry and weeks 12, 24, 36, and 48</time_frame>
      <description>Calculated as waist circumference at later time point minus waist circumference at study entry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute change in maximum hip circumference</measure>
      <time_frame>Study entry and weeks 12, 24, 36, and 48</time_frame>
      <description>Calculated as maximum hip circumference at later time point minus maximum hip circumference at study entry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute change in waist-hip ratio measured</measure>
      <time_frame>Study entry and weeks 12, 24, 36, and 48</time_frame>
      <description>Calculated as waist-hip ratio at later time point minus waist-hip ratio at study entry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute changes in fasting lipids</measure>
      <time_frame>Study entry and weeks 12, 24, and 48</time_frame>
      <description>Calculated as fasting lipids at later time point minus fasting lipids at study entry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute changes in glucose sensitivity</measure>
      <time_frame>Study entry and weeks 12, 24, 36, and 48</time_frame>
      <description>Calculated as glucose sensitivity at later time point minus glucose sensitivity at study entry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute changes in insulin sensitivity</measure>
      <time_frame>Study entry and weeks 12, 24, 36, and 48</time_frame>
      <description>Calculated as insulin sensitivity at later time point minus insulin sensitivity at study entry. Insulin will be measured from stored samples. Insulin sensitivity will be calculated as: HOMA-IR = (fasting glucose in mmol/L * fasting insulin in µU/L) /22.5.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>HIV I Infection</condition>
    <arm_group>
      <arm_group_label>Group 1: BIC-treated</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants taking bictegravir (BIC) + tenofovir alafenamide (TAF) + emtricitabine (FTC)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2: DTG-treated</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants taking dolutegravir (DTG) once daily + tenofovir disoproxil fumarate (TDF) + (FTC or lamivudine [3TC])</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3: Boosted DRV-treated</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants taking any regimen containing darunavir plus cobicistat (DRV/c)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Estradiol</intervention_name>
      <description>Oral 17-β estradiol 2 mg once daily will be initiated at study entry. At weeks 4, 12, 24, and 36, study clinicians may titrate 17-β estradiol in 2 mg increments to achieve the desired participant goals and target hormone concentrations, as measured locally at each visit.</description>
      <arm_group_label>Group 1: BIC-treated</arm_group_label>
      <arm_group_label>Group 2: DTG-treated</arm_group_label>
      <arm_group_label>Group 3: Boosted DRV-treated</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age greater than or equal to 18 years.&#xD;
  &#xD;
            2. Documentation of HIV-1 status.&#xD;
  &#xD;
            3. Assigned male sex at birth and identifies as a TW, female or transfeminine person.&#xD;
  &#xD;
            4. On ART for at least 24 weeks prior to study entry. Regimen changes within the 24 weeks&#xD;
               prior to study entry are acceptable, but candidates must have been on a stable regimen&#xD;
               for at least 28 days prior to study entry.&#xD;
  &#xD;
            5. On BIC/FTC/TAF, DTG/TDF/FTC or 3TC, or DRV/c-containing ART for at least 28 days prior&#xD;
               to study entry (single tablet regimen not required), and with no plans to change ART&#xD;
               regimen over the study duration of 48 weeks.&#xD;
  &#xD;
            6. Desire to initiate or restart FHT, regardless of orchiectomy status.&#xD;
  &#xD;
            7. HIV-1 RNA &lt;200 copies/mL at screening.&#xD;
  &#xD;
            8. HIV-1 RNA &lt;400 copies/mL available through routine clinical care between 24 and 96&#xD;
               weeks prior to study entry and while on ART. The HIV-1 RNA must be the most recent&#xD;
               value obtained between 24 and 96 weeks prior to study entry.&#xD;
  &#xD;
            9. The following laboratory values obtained within 60 days prior to study entry&#xD;
  &#xD;
                 -  Hemoglobin ≥9.0 g/dL&#xD;
  &#xD;
                 -  Platelet count ≥75,000/mm3&#xD;
  &#xD;
                 -  Estimated Glomerular Filtration Rate (eGFR) ≥30 mL/min/1.73m2 if on or switching&#xD;
                    to TAF, ≥50 mL/min/1.73m2 if on or switching to TDF without cobicistat, or ≥70&#xD;
                    mL/min/1.73m2 if on or switching to TDF in combination with cobicistat,&#xD;
                    calculated using the CKD-Epi equation&#xD;
  &#xD;
                 -  Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT),&#xD;
                    and alkaline phosphatase are within normal range per local laboratory range&#xD;
  &#xD;
                 -  Prolactin &lt;25 ng/dL&#xD;
  &#xD;
           10. Serum estradiol level &lt;75 pg/mL within 60 days prior to study entry.&#xD;
  &#xD;
           11. Willingness to avoid the use of prescribed, non-study provided FHT and non-prescribed&#xD;
               FHT during the study period, and no planned use of prescribed or non-prescribed&#xD;
               anti-androgens for the first 24 weeks of the study.&#xD;
  &#xD;
           12. Ability and willingness of participant to provide informed consent and ability and&#xD;
               willingness of participant to undergo study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Known clotting disorders, active deep vein thrombosis (DVT), pulmonary embolism (PE),&#xD;
               or history of these conditions, active arterial thromboembolic disease (e.g., stroke,&#xD;
               myocardial infarction), or history of these conditions.&#xD;
  &#xD;
            2. Known liver impairment or disease.&#xD;
  &#xD;
            3. History of chronic hepatitis B virus (HBV) infection or active HBV infection.&#xD;
  &#xD;
            4. History of current active hepatitis C virus (HCV) infection.&#xD;
  &#xD;
            5. Prohibited medication use (including drugs with known or expected DDIs with FHT or&#xD;
               ART) at time of study entry.&#xD;
  &#xD;
            6. Receipt of any estrogen therapy within 14 days prior to study entry for persons on&#xD;
               oral FHT, or within 30 days prior to entry for persons on injectable FHT.&#xD;
  &#xD;
            7. Known HIV-1 resistance mutations that would preclude remaining on current ART or a&#xD;
               switch to a study regimen, in the opinion of the site investigator.&#xD;
  &#xD;
            8. Personal history of breast cancer. or known personal history of breast cancer (BRCA)&#xD;
               gene.&#xD;
  &#xD;
            9. Known or a history of testicular cancer.&#xD;
  &#xD;
           10. Known or a history of gall bladder disease.&#xD;
  &#xD;
           11. Known or suspected pituitary adenoma.&#xD;
  &#xD;
           12. Known allergy/sensitivity or any hypersensitivity to components of study drugs or&#xD;
               their formulation.&#xD;
  &#xD;
           13. Known allergy/sensitivity or any hypersensitivity to components of study drugs or&#xD;
               their formulation.&#xD;
  &#xD;
           14. Suicidal ideation in the past 30 days or suicide attempt in the past 90 days, as&#xD;
               reported on the Columbia-Suicide Severity Rating Scale (C-SSRS).&#xD;
  &#xD;
           15. Serious illness requiring systemic treatment and/or hospitalization within 30 days&#xD;
               prior to entry. Stable (in the opinion of the site investigator) treatments for&#xD;
               chronic comorbidities are allowed.&#xD;
  &#xD;
           16. Presence of any other medical condition that would preclude FHT administration for&#xD;
               safety reasons, in the opinion of the site investigator.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Assigned male sex at birth and identifies as a TW, female or transfeminine person.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jordan E. Lake, MD, MSc</last_name>
      <role>Study Chair</role>
      <affiliation>Houston AIDS Research Team CRS</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Kimberly K. Scarsi, PharmD, MS, FCCP</last_name>
      <role>Study Chair</role>
      <affiliation>University of Nebraska</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jorge A. Gallardo-Cartagena, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Barranco CRS</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>UCSD Antiviral Research Center CRS (701)</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92103</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Steven Hendrickx</last_name>
        <phone>619-543-6968</phone>
        <email>smhendrickx@health.ucsd.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of California, San Francisco HIV/AIDS CRS (801)</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94110</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Elvira Gomez</last_name>
        <phone>415-476-4082</phone>
        <email>elvira.gomez@ucsf.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Colorado Hospital CRS (6101)</name>
        <address>
          <city>Aurora</city>
          <state>Colorado</state>
          <zip>80045</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Nicola Haakonsen</last_name>
        <phone>303-724-5931</phone>
        <email>nicola.haakonsen@cuanschutz.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Whitman-Walker Institute, Inc. CRS (31791)</name>
        <address>
          <city>Washington</city>
          <state>District of Columbia</state>
          <zip>20005</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Avery Wimpelberg</last_name>
        <phone>202-797-3589</phone>
        <email>awimpelberg@whitman-walker.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Johns Hopkins University CRS (201)</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21205</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Rebecca L. Becker</last_name>
        <phone>410-614-4036</phone>
        <email>rbecke22@jhmi.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Massachusetts General Hospital CRS (MGH CRS) (101)</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Amy Sbrolla</last_name>
        <phone>617-726-5598</phone>
        <email>asbrolla@mgh.harvard.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Washington University Therapeutics (WT) CRS (2101)</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63110-1010</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Michael Klebert</last_name>
        <phone>314-454-0058</phone>
        <email>mklebert@wustl.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>New Jersey Medical School Clinical Research Center CRS (31786)</name>
        <address>
          <city>Newark</city>
          <state>New Jersey</state>
          <zip>07103</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Rondalya DeShields</last_name>
        <phone>973-972-3729</phone>
        <email>deshierd@njms.rutgers.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Weill Cornell Chelsea CRS (7804)</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10010</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Rebecca Fry</last_name>
        <phone>212-746-7204</phone>
        <email>ref2007@med.cornell.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Columbia Physicians &amp; Surgeons (P&amp;S) CRS (30329)</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10032-3732</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Mascha Elskamp</last_name>
        <phone>212-305-2201</phone>
        <email>me2500@cumc.columbia.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Weill Cornell Uptown CRS</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10065</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jonathan Berardi</last_name>
        <phone>212-746-7864</phone>
        <email>jlb4002@med.cornell.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Chapel Hill CRS (3201)</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27599-7215</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Susan Pedersen</last_name>
        <phone>919-966-6713</phone>
        <email>spederse@med.unc.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Greensboro CRS (3203)</name>
        <address>
          <city>Greensboro</city>
          <state>North Carolina</state>
          <zip>27401</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kelly Phillips</last_name>
        <phone>336-832-7297</phone>
        <email>kelly.phillips@conehealth.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Case CRS (2501)</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44106</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Julie Pasternak</last_name>
        <phone>216-844-2738</phone>
        <email>pasternak.julie@clevelandactu.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ohio State University CRS (2301)</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43210-1282</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lindsay Summers</last_name>
        <phone>614-293-8529</phone>
        <email>lindsay.summers@osumc.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Vanderbilt Therapeutics CRS</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37204</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Beverly Woodward</last_name>
        <phone>615-936-8516</phone>
        <email>beverly.o.woodward@vumc.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Houston AIDS Research Team CRS (31473)</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Maria Laura Martinez</last_name>
        <phone>713-500-6718</phone>
        <email>maria.l.martinez@uth.tmc.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Washington Positive Research CRS (1401)</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98104</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Christine Jonsson</last_name>
        <phone>206-744-8886</phone>
        <email>cjonsson@uw.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Gaborone CRS (12701)</name>
        <address>
          <city>Gaborone</city>
          <country>Botswana</country>
        </address>
      </facility>
      <contact>
        <last_name>Unoda A Chakalisa</last_name>
        <phone>267-393-1353</phone>
        <email>uchakalisa@bhp.org.bw</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Nossa Senhora da Conceicao CRS (12201)</name>
        <address>
          <city>Porto Alegre</city>
          <zip>91350-200</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <contact>
        <last_name>Rita de Cassia Alves Lira</last_name>
        <phone>+55 51-33572603</phone>
        <email>lrita@ghc.com.br</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nutrición-Mexico CRS (32078)</name>
        <address>
          <city>Mexico City</city>
          <state>Tlalpan</state>
          <zip>14080</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <contact>
        <last_name>Brenda Eloisa Crabtree-Ramirez</last_name>
        <phone>52-5555130010</phone>
        <email>brenda.crabtree@infecto.mx</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Barranco CRS (11301)</name>
        <address>
          <city>Lima</city>
          <zip>4</zip>
          <country>Peru</country>
        </address>
      </facility>
      <contact>
        <last_name>María del Pilar Estrella Caballero</last_name>
        <phone>+51 206-7800</phone>
        <email>mestrella@impactaperu.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>De La Salle Health Science Institute Angelo King Medical Research Center (DLSHSI-AKMRC) (31981)</name>
        <address>
          <city>Cavite</city>
          <zip>4114</zip>
          <country>Philippines</country>
        </address>
      </facility>
      <contact>
        <last_name>Maria Tarcela Gler</last_name>
        <phone>+63 917-823-0431</phone>
        <email>msgler@my.dlshsi.edu.ph</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Soweto ACTG CRS (12301)</name>
        <address>
          <city>Johannesburg</city>
          <zip>1864</zip>
          <country>South Africa</country>
        </address>
      </facility>
      <contact>
        <last_name>Suri Moonsamy</last_name>
        <phone>+27-11-989-9905</phone>
        <email>moonsamys@phru.co.za</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (31802)</name>
        <address>
          <city>Bangkok</city>
          <state>Patumwan</state>
          <zip>10330</zip>
          <country>Thailand</country>
        </address>
      </facility>
      <contact>
        <last_name>Parawee Thongpaeng</last_name>
        <phone>66-2-6523040</phone>
        <email>parawee.t@hivnat.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (31784)</name>
        <address>
          <city>Chiang Mai</city>
          <zip>50200</zip>
          <country>Thailand</country>
        </address>
      </facility>
      <contact>
        <last_name>Daralak Tavornprasit</last_name>
        <phone>66 5393 6148</phone>
        <phone_ext>176</phone_ext>
        <email>daralak.t@cmu.ac.th</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hanoi Medical University (HMU) (32482)</name>
        <address>
          <city>Hanoi</city>
          <country>Vietnam</country>
        </address>
      </facility>
      <contact>
        <last_name>Ha Viet Tran</last_name>
        <phone>84-24-3211-5839</phone>
        <email>vietha@live.unc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>Botswana</country>
      <country>Brazil</country>
      <country>Mexico</country>
      <country>Peru</country>
      <country>Philippines</country>
      <country>South Africa</country>
      <country>Thailand</country>
      <country>United States</country>
      <country>Vietnam</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HIV</keyword>
    <keyword>Transgender women</keyword>
    <keyword>Estradiol</keyword>
    <keyword>ART</keyword>
    <keyword>Drug interactions</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Estradiol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Individual participant data that underlie results in the publication, after deidentification.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.</ipd_time_frame>
      <ipd_access_criteria>With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.&#xD;
  For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group.&#xD;
  By what mechanism will data be made available? Researchers may submit a request for access to data using the AIDS Clinical Trials Group &quot;Data Request&quot; form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06005610
  org study id: A5403
  secondary id: 38806
  nct id: NCT06005610
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  Transgender women (TW) are a key population and priority for HIV treatment. More research is
        needed to develop evidence-based clinical guidance when it comes to choosing antiretroviral
        treatment (ART) regimens for TW on feminizing hormonal therapy (FHT). Concerns about ART
        interacting with FHT and decreasing its effectiveness can lead to decreased ART adherence and
        increased viral loads.
  
        The GET IT RiGHT trial aims to address concerns about drug-drug interactions (DDIs) between
        ART and FHT while providing access to hormonal therapy to TW living with HIV. Data suggest
        that access to FHT improves adherence to HIV treatment and decreases treatment interruptions.
  
        This is an open-label, non-randomized, 3-group trial of adult TW and other individuals
        identifying as female or transfeminine but with male sex assigned at birth living with HIV.
        Participants will be on ART at entry and receive study-supplied 17-β estradiol for FHT for 48
        weeks.
  
        The primary objectives of the study are to 1) assess whether TW continue to achieve
        therapeutic concentrations of ART while receiving FHT for 48 weeks and 2) assess whether
        serum estradiol concentrations on FHT (across a range of estradiol doses) vary between
        boosted and un-boosted ART regimens.
  A5403 is a phase IIb, 48-week, open-label, non-randomized, 3-group trial, of 90 adult (≥18
        years) transgender women and other individuals identifying as female or transfeminine but
        with male sex assigned at birth (TW) living with HIV on suppressive antiretroviral therapy
        (ART) and not currently on FHT. The trial will target at least 50% enrollment of participants
        identifying as non-white or Latine.
  
        The trial consists of three groups, a BIC-treated group (BIC/TAF/FTC; n=30) (Group 1), a
        DTG-treated group (DTG/TDF/FTC or 3TC; n=30) (Group 2), and a boosted DRV-treated group
        (DRV/c; n=30) (Group 3), for a total of 90 participants.
  
        All participants will continue on ART (not provided by the trial) and receive study-supplied
        17-β estradiol for weeks 0-48. At entry, participants will be assigned to one of the three
        analysis groups based on their current ART regimen. Participants on other ART regimens at
        screening who are willing to switch to one of the regimens above, may also be enrolled.
  
        All participants will receive study supplied 17-β estradiol for weeks 0-48. Oral 17-β
        estradiol 2 mg once daily will be initiated at study entry. At weeks 4, 12, 24, and 36, study
        clinicians may titrate 17-β estradiol in 2 mg increments as described in the protocol.
  
        Intensive PK subgroup (n=15 per ART group): At entry (week 0), an 8-hour intensive PK
        sampling will assess ART exposure prior to FHT initiation. At week 24, intensive sampling
        will be repeated to assess 17-β estradiol and ART exposure. A final intensive PK visit will
        occur at week 48 to assess 17-β estradiol and ART exposure at the maximal FHT dosing achieved
        during the study period.
  
        Sparse PK sampling: all participants not participating in an intensive PK sampling visit on
        the same day will have timed, sparse PK sampling collected at each visit to characterize the
        trough plasma (BIC, DTG, and DRV) and intracellular ART (TFV-DP, FTC-TP, 3TC-TP)
        concentrations to evaluate the relationship of ART PK exposure across a range of 17-β
        estradiol doses.
  
        FHT satisfaction and acceptability:
  
        To measure acceptability, participants will be asked to self-report the degree to which they
        find the intervention appropriate and useful using Likert-type agreement scales at three
        study time points: entry, 24 weeks, and 48 weeks. To measure satisfaction, the 12-question
        Transgender Congruence Scale (TCS) will be used, which will assess associations between
        gender-affirming treatments, perceived gender congruence, and satisfaction at three study
        time points: entry, 24 weeks, and 48 weeks. In addition, brief, 20-minute, semi-structured
        interviews will be conducted with 30 purposively sampled participants across English- or
        Spanish-speaking sites to provide an opportunity for more in-depth (open-ended) feedback on
        intervention satisfaction and acceptability at three time points: entry, 24 weeks, and 48
        weeks.
  
        Other assessments throughout the study include: anthropometric measurements (including
        weight, height, minimum waist circumference, and maximum hip circumference), routine
        chemistry and hematology labs, HIV-1 RNA, CD4+ and CD8+ T cell counts and percentages,
        lipids, glucose and insulin, non-estradiol hormone concentrations, stored PBMC, plasma, and
        serum, and ART and FHT adherence assessments.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Geometric Mean Ratio of ART Analytes BIC, DTG, and DRV trough concentrations (Ctrough) in plasma at each received dose of oral 17-β estradiol
  time frame: Study Entry and Weeks 4, 12, 24, 36, and 48
  description: Log-transformed trough concentrations (Ctrough) in ng/mL of the analytes BIC, DTG, and DRV from plasma samples collected 22-26 hours post ART dose, measured over 48 weeks.
  measure: Percentage of Participants with ART Analyte trough concentration (Ctrough) above drug-specific threshold
  time frame: Study Entry and Weeks 4, 12, 24, 36, and 48
  description: Trough concentration of the analytes BIC, DTG, and DRV in plasma at each received dose of 17-β estradiol summarized at the participant level as indicator of concentration being above drug-specific threshold.
  measure: Trough serum total estradiol assessed at each received dose of oral 17-β estradiol as quantified via batch testing at central lab.
  time frame: Study Entry and Weeks 4, 12, 24, 36, and 48
  description: Trough concentrations of Total 17-β estradiol in ng/mL from serum samples collected 22-26 hours post 17-β estradiol dose. Results < Lower Limit of Quantification (LLoQ) at entry will be imputed as 0 ng/mL at one-half the LLoQ value at visits post-entry.
  measure: Trough concentrations of TFV-DP, FTC-TP, and 3TC-TP in non-viable PBMCs at each received dose of oral 17-β estradiol
  time frame: Study Entry and Weeks 4, 12, 24, 36 and 48
  description: Intra-person geometric ratios of trough ART concentration at each received estradiol dose relative to pre-FHT (i.e., baseline).
  measure: Percentage of Participants with TFV-DP, FTC-TP, and 3TC-TP trough concentration above drug-specific threshold
  time frame: Study Entry and Weeks 4, 12, 24, 36 and 48
  description: Trough concentration of the analytes TFV-DP, FTC-TP, and 3TC-TP in non-viable PBMCs at each received dose of 17-β estradiol summarized at the participant level as indicator of concentration being above drug-specific externally defined threshold.
  measure: Percentage of participants with an occurrence of any reportable adverse event related to 17-β estradiol
  time frame: Study entry to Week 48
  description: The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017, and the DAIDS EAE Manual Version 2.0 will be used.
  measure: Percentage of participants with an occurrence of SAEs as defined by International Conference on Harmonization (ICH) and new events of CAD/CVD, cancer, DM/pre-DM, and vascular event
  time frame: Study entry to Week 48
  description: Post-entry and while on study treatment, all signs (including an abnormal laboratory finding), symptoms, or diagnoses new in onset or aggravated in severity or frequency from the baseline condition, indicated as related to 17-β estradiol by the site (or the CMC if adjudication differs from that of the site investigator).
  measure: Percentage of participants with serum total testosterone < 50 ng/dL at each received dose of oral 17-β estradiol
  time frame: Study entry and Weeks 4, 12, 24, 36, 48
  description: Results < LLoQ will be considered to be <50 ng/dL. If multiple observations are available at the same estradiol dose, the last testosterone concentration (based on calendar time) taken will be used.
  measure: Percentage of participants with virologic suppression of HIV
  time frame: Study entry and weeks 12, 24, 36, and 48
  description: Virologic suppression of HIV is defined as plasma HIV-1 viral load <50 copies/mL
  measure: Absolute changes in overall transgender congruence score
  time frame: Study entry and weeks 24, and 48
  description: The overall transgender congruence score is calculated from participant response to the 12-question Transgender Congruence Scale (TCS). Participants rate each item on a 5-point Likert-type scale (i.e., 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree nor disagree, 4 = somewhat agree, 5 = strongly agree). Questions 'The way my body currently looks does not represent my gender identity.', 'I do not feel that my appearance reflects my gender identity.', and 'I am not proud of my gender identity.' are reversed scored. The overall score is the average of the response to the 12 questions, with higher scores indicating a higher level of congruence. Positive changes from baseline indicate improvement in transgender congruence.
  measure: Area under the curve over 8 hours (AUC 0-8h) of 17-β estradiol
  time frame: Study entry and Weeks 24, and 48
  description: From pre-dose, 1, 2, 3, 4, 6, and 8 hours post dosing at entry and weeks 24 and 48.
  The AUC will use the linear up/log down version of the trapezoidal rule in non-compartmental analysis using Phoenix WinNonLin (Certara®). This version of the trapezoidal rule uses linear interpolation between untransformed data up to Cmax, and between log-transformed data from Cmax through Clast.
  measure: Percent change in weight
  time frame: Study entry and weeks 12, 24, 36, and 48
  description: Calculated by dividing weight at later time point minus weight at study entry by weight at study entry.
  measure: Percent change in BMI
  time frame: Study entry and weeks 12, 24, 36, and 48
  description: Calculated by dividing BMI at later time point minus BMI at study entry by BMI at study entry.
  measure: Absolute change in minimum waist circumference
  time frame: Study entry and weeks 12, 24, 36, and 48
  description: Calculated as waist circumference at later time point minus waist circumference at study entry.
  measure: Absolute change in maximum hip circumference
  time frame: Study entry and weeks 12, 24, 36, and 48
  description: Calculated as maximum hip circumference at later time point minus maximum hip circumference at study entry.
  measure: Absolute change in waist-hip ratio measured
  time frame: Study entry and weeks 12, 24, 36, and 48
  description: Calculated as waist-hip ratio at later time point minus waist-hip ratio at study entry.
  measure: Absolute changes in fasting lipids
  time frame: Study entry and weeks 12, 24, and 48
  description: Calculated as fasting lipids at later time point minus fasting lipids at study entry.
  measure: Absolute changes in glucose sensitivity
  time frame: Study entry and weeks 12, 24, 36, and 48
  description: Calculated as glucose sensitivity at later time point minus glucose sensitivity at study entry.
  measure: Absolute changes in insulin sensitivity
  time frame: Study entry and weeks 12, 24, 36, and 48
  description: Calculated as insulin sensitivity at later time point minus insulin sensitivity at study entry. Insulin will be measured from stored samples. Insulin sensitivity will be calculated as: HOMA-IR = (fasting glucose in mmol/L * fasting insulin in µU/L) /22.5.
  arm group label: Group 1: BIC-treated
  arm group type: Experimental
  description: Participants taking bictegravir (BIC) + tenofovir alafenamide (TAF) + emtricitabine (FTC)
  arm group label: Group 2: DTG-treated
  arm group type: Experimental
  description: Participants taking dolutegravir (DTG) once daily + tenofovir disoproxil fumarate (TDF) + (FTC or lamivudine [3TC])
  arm group label: Group 3: Boosted DRV-treated
  arm group type: Experimental
  description: Participants taking any regimen containing darunavir plus cobicistat (DRV/c)
  intervention type: Drug
  intervention name: Estradiol
  description: Oral 17-β estradiol 2 mg once daily will be initiated at study entry. At weeks 4, 12, 24, and 36, study clinicians may titrate 17-β estradiol in 2 mg increments to achieve the desired participant goals and target hormone concentrations, as measured locally at each visit.
  arm group label: Group 1: BIC-treated
  arm group label: Group 2: DTG-treated
  arm group label: Group 3: Boosted DRV-treated
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Assigned male sex at birth and identifies as a TW, female or transfeminine person.
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jordan E. Lake, MD, MSc
  role: Study Chair
  affiliation: Houston AIDS Research Team CRS
  last name: Kimberly K. Scarsi, PharmD, MS, FCCP
  role: Study Chair
  affiliation: University of Nebraska
  last name: Jorge A. Gallardo-Cartagena, MD
  role: Study Chair
  affiliation: Barranco CRS
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  country: Botswana
  country: Brazil
  country: Mexico
  country: Peru
  country: Philippines
  country: South Africa
  country: Thailand
  country: United States
  country: Vietnam
  responsible party type: Sponsor
  mesh term: Estradiol
  sharing ipd: Yes
  ipd description: Individual participant data that underlie results in the publication, after deidentification.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.
  ipd access criteria: With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.
  For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group.
  By what mechanism will data be made available? Researchers may submit a request for access to data using the AIDS Clinical Trials Group "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.