<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/NCT01714414</url>
  </required_header>
  <id_info>
    <org_study_id>LMU-IMPH-FATI-01</org_study_id>
    <nct_id>NCT01714414</nct_id>
  </id_info>
  <brief_title>A Trial to Confirm a Sustained Virological Suppression Defined as HIV-RNA &lt;50 Copies/ml of 3 Different Doses of Fozivudine in Context to a Standard Zidovudine Based Antiretroviral Therapy Regimen</brief_title>
  <acronym>FATI-01</acronym>
  <official_title>A Prospective, Multicenter, Open, Randomized Phase 2a Trial to Confirm a Sustained Virological Suppression Defined as HIV-RNA &lt;50 Copies/ml of 3 Different Doses of Fozivudine in Context to a Standard Zidovudine Based Antiretroviral Therapy Regimen After 24 Weeks of Treatment in ART naïve, Non Subtype B HIV-1 Infected Individuals From Tanzania and Ivory Coast</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michael Hoelscher</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European and Developing Countries Clinical Trials Partnership (EDCTP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>German Federal Ministry of Education and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute for Medical Research, Tanzania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Treichville Academic hospital center, Division of infectious and tropical diseases (SMIT)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ANRS, Emerging Infectious Diseases</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kumasi Centre for Collaborative Research (KCCR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bernhard Nocht Institute for Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pharmaceutical Company (Chiracon GmbH)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pharmaceutical Company (STADA Vietnam Joint Venture Co. Ltd.)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, multicenter, open, randomized Phase 2a trial to confirm a sustained&#xD;
      virological suppression defined as HIV-RNA &lt;50 copies/ml of 3 different doses of Fozivudine&#xD;
      in context to a standard Zidovudine based antiretroviral therapy regimen after 24 weeks of&#xD;
      treatment in ART naïve, non subtype B HIV-1 infected individuals from Tanzania and Ivory&#xD;
      Coast.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will evaluate four different oral 1st line antiretroviral regimens: three study&#xD;
      arms will contain different doses of Fozivudine (FZD) plus Lamivudine (3TC) in a twice daily&#xD;
      or once daily application plus once daily Efavirenz. The 4th study arm will contain standard&#xD;
      Zidovudine (AZT)/Lamivudine (3TC) twice daily in a fixed dose combination plus once daily&#xD;
      Efavirenz. The treatment duration will be 24 weeks.&#xD;
&#xD;
      In a pharmacokinetic Sub-Study Pharmacokinetic (PK) characteristics will be determined under&#xD;
      controlled conditions in a sub population to evaluate PK values of the study drugs.&#xD;
&#xD;
      Primary Objective&#xD;
&#xD;
      The primary objective is to confirm a sustained virological suppression (HIV RNA &lt;50&#xD;
      copies/ml) after 24 weeks of treatment between three different doses of Fozivudine (FZD)&#xD;
      based antiretroviral 1st line treatment regimen in context to a standard Zidovudine (ZDV)&#xD;
      based treatment regimen in non subtype B HIV-1 infected individuals from Africa.&#xD;
&#xD;
      Secondary Objectives&#xD;
&#xD;
        1. HIV-RNA log10 reduction of HIV-RNA at 2, 4 and 8 weeks of treatment between different&#xD;
           arms&#xD;
&#xD;
        2. Virological response (HIV RNA &lt;50 copies/ml) at 8 and 12 weeks of treatment between&#xD;
           different arms&#xD;
&#xD;
        3. Virological response (HIV RNA &lt;400 copies/ml) at 8, 12 and 24 weeks of treatment between&#xD;
           different arms&#xD;
&#xD;
        4. Immunologic response: variation in CD4 lymphocytes between different arms&#xD;
&#xD;
        5. Drug toxicity, particularly anaemia, neutropenia and gastrointestinal adverse events&#xD;
&#xD;
        6. Resistance pattern for in patients with virological failure&#xD;
&#xD;
        7. Clinical trial capacity building of African study sites within the FATI network&#xD;
&#xD;
        8. Establishment of a Fozivudine Drug developing consortium (NET) including members of&#xD;
           pharmaceutical manufacturers in Asia, Africa and Europe.&#xD;
&#xD;
        9. Development and piloting of a capacity development monitoring and evaluation framework&#xD;
&#xD;
      Pharmacological Objectives&#xD;
&#xD;
        1. Pharmacokinetic assessments after the first intake of study drugs in a subset of study&#xD;
           participants (Pharmacokinetic sub study)&#xD;
&#xD;
        2. Pharmacokinetic assessments at steady state after four weeks of study drugs in a subset&#xD;
           of study participants (Pharmacokinetic sub study)&#xD;
&#xD;
      Study Population and Study Duration&#xD;
&#xD;
      A total of 120 ART naive HIV-1 infected individuals with the indication to start&#xD;
      antiretroviral treatment according to WHO and country guidelines will be enrolled at two&#xD;
      study sites in Côte d'Ivoire and Tanzania. Each of the two sites will enroll 60 participants&#xD;
      (15 participants per arm). For the PK Sub-Study 6 participants per study arm (total 24&#xD;
      participants will be included.&#xD;
&#xD;
      A minimum of 30% gender representation (female or male) participants will be requested per&#xD;
      site. Recruitment, screening and enrollment of study participants are expected to be&#xD;
      completed after 9 months. Patient treatment is 24 weeks. So patient related study procedures&#xD;
      will take 15 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with plasma HIV RNA &lt; 50 copies/ml</measure>
    <time_frame>at week 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with plasma HIV RNA &lt;50 copies/ml</measure>
    <time_frame>at week 8 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with plasma HIV RNA &lt; 400 copies/ml</measure>
    <time_frame>at week 8, 12 and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean HIV log10 reduction compared to baseline</measure>
    <time_frame>at week 2, 4 and 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of circulating total lymphocyte count</measure>
    <time_frame>up to week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of circulating CD4+ lymphocyte count</measure>
    <time_frame>up to week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters (Cmax, AUC, CL/f, CLR, t1/2) before and after the first dose</measure>
    <time_frame>Day 1</time_frame>
    <description>Various pharmacokinetic parameters (Cmax, AUC, CL/f, CLR, t1/2) will be assessed before the first treatment and during the course of 12 hours after the first treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters (Cmax, AUC, CL/f, CLR, t1/2) at steady state</measure>
    <time_frame>Week 4</time_frame>
    <description>Various pharmacokinetic parameters (Cmax, AUC, CL/f, CLR, t1/2) will be assessed during the course of 12 hours after 4 weeks of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of clinical events stage 3 or 4 of WHO HIV classification</measure>
    <time_frame>up to week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Adverse Events as Measure of safety and tolerability</measure>
    <time_frame>up to week 24</time_frame>
    <description>The number of Adverse Events and also the quality, severity and relatedness to study drug are documented and analysed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of resistance mutations after confirmed treatment failure (confirmed HIV RNA &gt; 1000 copies/ml</measure>
    <time_frame>at week 12 and week 24</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>HIV-1 Infection</condition>
  <arm_group>
    <arm_group_label>FZD 600mg twice daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FZD 3 tablets (600mg) twice daily / 3TC 1 tablet (150mg) twice daily / EFV 1 capsule (600mg) once daily for the duration of 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FZD 800mg once daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FZD 4 tablets (800mg) once daily / 3TC 2 tablets (150mg) once daily / EFV 1 capsule (600mg) once daily for the duration of 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FZD 1200mg once daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FZD 6 tablets (1200mg) once daily / 3TC 2 tablets (150mg) once daily / EFV 1 capsule (600mg) once daily for the duration of 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AZT twice daily</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 tablet Combivir(AZT 300mg/3TC 150mg) twice daily / EFV 1 capsule (600mg) once daily for the duration of 24 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FZD</intervention_name>
    <arm_group_label>FZD 1200mg once daily</arm_group_label>
    <arm_group_label>FZD 600mg twice daily</arm_group_label>
    <arm_group_label>FZD 800mg once daily</arm_group_label>
    <other_name>Fozivudine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3TC</intervention_name>
    <arm_group_label>AZT twice daily</arm_group_label>
    <arm_group_label>FZD 1200mg once daily</arm_group_label>
    <arm_group_label>FZD 600mg twice daily</arm_group_label>
    <arm_group_label>FZD 800mg once daily</arm_group_label>
    <other_name>Lamivudine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EFV</intervention_name>
    <arm_group_label>AZT twice daily</arm_group_label>
    <arm_group_label>FZD 1200mg once daily</arm_group_label>
    <arm_group_label>FZD 600mg twice daily</arm_group_label>
    <arm_group_label>FZD 800mg once daily</arm_group_label>
    <other_name>Efavirenz</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZT</intervention_name>
    <arm_group_label>AZT twice daily</arm_group_label>
    <other_name>Zidovudine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female ≥ 18 years of age.&#xD;
&#xD;
          2. Provide written or thump printed informed consent prior to all trial-related&#xD;
             procedures&#xD;
&#xD;
          3. HIV-1 positive with an indication to start antiretroviral therapy (ART) according to&#xD;
             WHO and/or country guidelines&#xD;
&#xD;
          4. ART naïve, including no history of antiretroviral medication during PMTCT or PEP&#xD;
&#xD;
          5. Patient agrees not to take any concomitant medication during the trial without&#xD;
             informing the investigator. Traditional medicines should be specified with concomitant&#xD;
             medications.&#xD;
&#xD;
          6. Availability throughout the study&#xD;
&#xD;
          7. Female patients of childbearing potential must have a negative pregnancy test and&#xD;
             agree to use a highly effective method of birth control throughout participation in&#xD;
             the trial and for 10 weeks after last dose (to cover duration of ovulation).&#xD;
&#xD;
          8. Agree to have home visits or active tracing if lost to follow up or any other event&#xD;
             justifying a rapid visit of the patient at the clinical trial centre.&#xD;
&#xD;
          9. CD4 count ≥100 cells/μl&#xD;
&#xD;
         10. Hb ≥9.5 g/dl&#xD;
&#xD;
         11. Platelets ≥50,000 cells/mm3&#xD;
&#xD;
         12. Neutrophils ≥500 cells/ mm3&#xD;
&#xD;
         13. Bilirubin &lt;2.5 x uln&#xD;
&#xD;
         14. ALT &lt;2.5 x uln&#xD;
&#xD;
         15. Exclusion of Severe hepatic insufficiency (PT&lt;50%)&#xD;
&#xD;
         16. Creatinine clearance calculated by Cockroft's formula ≥50 ml/min&#xD;
&#xD;
         17. Urine dipstick for protein and blood: negative or trace&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Deficiency in the patient, rendering it difficult, if not impossible, for him/her to&#xD;
             take part in the trial or understand the information provided to him/her&#xD;
&#xD;
          2. Presence of an uncontrolled, ongoing, opportunistic infection or of any severe or&#xD;
             progressive disease including active TB or any other justified reason which in the&#xD;
             opinion of the investigator could significantly inhibit study procedures. This&#xD;
             includes any clinical signs possibly associated with any WHO stage 3 or 4, with still&#xD;
             unconfirmed diagnosis such as fever, weight loss, diarrhoea or unexplained cough.&#xD;
&#xD;
          3. HIV-2 infection&#xD;
&#xD;
          4. Pregnancy or lactating mother&#xD;
&#xD;
          5. Unlikely to comply with protocol as judged by the principal investigator or his&#xD;
             designate&#xD;
&#xD;
          6. Use of experimental therapeutic agents within 30 days of study entry.&#xD;
&#xD;
          7. Hepatitis B with positive HBsAg.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Hoelscher, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Department for Infectious Diseases and Tropical Medicine, Klinikum of the University of Munich, Leopoldstrasse 5, 80802, Munich, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service des Maladies Infectieuses et Tropicales, CHU de Treichville,</name>
      <address>
        <city>Abidjan</city>
        <zip>BPV3</zip>
        <country>Côte D'Ivoire</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NIMR - Mbeya Medical Research Programme,</name>
      <address>
        <city>Mbeya</city>
        <zip>PO Box 2410</zip>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Côte D'Ivoire</country>
    <country>Tanzania</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>March 6, 2018</last_update_submitted>
  <last_update_submitted_qc>March 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>Michael Hoelscher</investigator_full_name>
    <investigator_title>Chief Investigator</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Fozivudine</keyword>
  <keyword>Zidovudine</keyword>
  <keyword>FATI</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lamivudine</mesh_term>
    <mesh_term>Zidovudine</mesh_term>
    <mesh_term>Efavirenz</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01714414
org study id: LMU-IMPH-FATI-01
nct id: NCT01714414
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
A prospective, multicenter, open, randomized Phase 2a trial to confirm a sustained
      virological suppression defined as HIV-RNA <50 copies/ml of 3 different doses of Fozivudine
      in context to a standard Zidovudine based antiretroviral therapy regimen after 24 weeks of
      treatment in ART naïve, non subtype B HIV-1 infected individuals from Tanzania and Ivory
      Coast.
The study will evaluate four different oral 1st line antiretroviral regimens: three study
      arms will contain different doses of Fozivudine (FZD) plus Lamivudine (3TC) in a twice daily
      or once daily application plus once daily Efavirenz. The 4th study arm will contain standard
      Zidovudine (AZT)/Lamivudine (3TC) twice daily in a fixed dose combination plus once daily
      Efavirenz. The treatment duration will be 24 weeks.

      In a pharmacokinetic Sub-Study Pharmacokinetic (PK) characteristics will be determined under
      controlled conditions in a sub population to evaluate PK values of the study drugs.

      Primary Objective

      The primary objective is to confirm a sustained virological suppression (HIV RNA <50
      copies/ml) after 24 weeks of treatment between three different doses of Fozivudine (FZD)
      based antiretroviral 1st line treatment regimen in context to a standard Zidovudine (ZDV)
      based treatment regimen in non subtype B HIV-1 infected individuals from Africa.

      Secondary Objectives

        1. HIV-RNA log10 reduction of HIV-RNA at 2, 4 and 8 weeks of treatment between different
           arms

        2. Virological response (HIV RNA <50 copies/ml) at 8 and 12 weeks of treatment between
           different arms

        3. Virological response (HIV RNA <400 copies/ml) at 8, 12 and 24 weeks of treatment between
           different arms

        4. Immunologic response: variation in CD4 lymphocytes between different arms

        5. Drug toxicity, particularly anaemia, neutropenia and gastrointestinal adverse events

        6. Resistance pattern for in patients with virological failure

        7. Clinical trial capacity building of African study sites within the FATI network

        8. Establishment of a Fozivudine Drug developing consortium (NET) including members of
           pharmaceutical manufacturers in Asia, Africa and Europe.

        9. Development and piloting of a capacity development monitoring and evaluation framework

      Pharmacological Objectives

        1. Pharmacokinetic assessments after the first intake of study drugs in a subset of study
           participants (Pharmacokinetic sub study)

        2. Pharmacokinetic assessments at steady state after four weeks of study drugs in a subset
           of study participants (Pharmacokinetic sub study)

      Study Population and Study Duration

      A total of 120 ART naive HIV-1 infected individuals with the indication to start
      antiretroviral treatment according to WHO and country guidelines will be enrolled at two
      study sites in Côte d'Ivoire and Tanzania. Each of the two sites will enroll 60 participants
      (15 participants per arm). For the PK Sub-Study 6 participants per study arm (total 24
      participants will be included.

      A minimum of 30% gender representation (female or male) participants will be requested per
      site. Recruitment, screening and enrollment of study participants are expected to be
      completed after 9 months. Patient treatment is 24 weeks. So patient related study procedures
      will take 15 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of patients with plasma HIV RNA < 50 copies/ml
time frame: at week 24
measure: Proportion of patients with plasma HIV RNA <50 copies/ml
time frame: at week 8 and 12
measure: Proportion of patients with plasma HIV RNA < 400 copies/ml
time frame: at week 8, 12 and 24
measure: Mean HIV log10 reduction compared to baseline
time frame: at week 2, 4 and 8
measure: Variation of circulating total lymphocyte count
time frame: up to week 24
measure: Variation of circulating CD4+ lymphocyte count
time frame: up to week 24
measure: Pharmacokinetic parameters (Cmax, AUC, CL/f, CLR, t1/2) before and after the first dose
time frame: Day 1
description: Various pharmacokinetic parameters (Cmax, AUC, CL/f, CLR, t1/2) will be assessed before the first treatment and during the course of 12 hours after the first treatment.
measure: Pharmacokinetic parameters (Cmax, AUC, CL/f, CLR, t1/2) at steady state
time frame: Week 4
description: Various pharmacokinetic parameters (Cmax, AUC, CL/f, CLR, t1/2) will be assessed during the course of 12 hours after 4 weeks of treatment.
measure: Proportion of clinical events stage 3 or 4 of WHO HIV classification
time frame: up to week 24
measure: Number of participants with Adverse Events as Measure of safety and tolerability
time frame: up to week 24
description: The number of Adverse Events and also the quality, severity and relatedness to study drug are documented and analysed.
measure: Incidence of resistance mutations after confirmed treatment failure (confirmed HIV RNA > 1000 copies/ml
time frame: at week 12 and week 24
arm group label: FZD 600mg twice daily
arm group type: Experimental
description: FZD 3 tablets (600mg) twice daily / 3TC 1 tablet (150mg) twice daily / EFV 1 capsule (600mg) once daily for the duration of 24 weeks
arm group label: FZD 800mg once daily
arm group type: Experimental
description: FZD 4 tablets (800mg) once daily / 3TC 2 tablets (150mg) once daily / EFV 1 capsule (600mg) once daily for the duration of 24 weeks
arm group label: FZD 1200mg once daily
arm group type: Experimental
description: FZD 6 tablets (1200mg) once daily / 3TC 2 tablets (150mg) once daily / EFV 1 capsule (600mg) once daily for the duration of 24 weeks
arm group label: AZT twice daily
arm group type: Active Comparator
description: 1 tablet Combivir(AZT 300mg/3TC 150mg) twice daily / EFV 1 capsule (600mg) once daily for the duration of 24 weeks
intervention type: Drug
intervention name: FZD
arm group label: FZD 1200mg once daily
arm group label: FZD 600mg twice daily
arm group label: FZD 800mg once daily
other name: Fozivudine
intervention type: Drug
intervention name: 3TC
arm group label: AZT twice daily
arm group label: FZD 1200mg once daily
arm group label: FZD 600mg twice daily
arm group label: FZD 800mg once daily
other name: Lamivudine
intervention type: Drug
intervention name: EFV
arm group label: AZT twice daily
arm group label: FZD 1200mg once daily
arm group label: FZD 600mg twice daily
arm group label: FZD 800mg once daily
other name: Efavirenz
intervention type: Drug
intervention name: AZT
arm group label: AZT twice daily
other name: Zidovudine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Hoelscher, Prof.
role: Study Director
affiliation: Department for Infectious Diseases and Tropical Medicine, Klinikum of the University of Munich, Leopoldstrasse 5, 80802, Munich, Germany
facility: 
facility: 
country: Côte D'Ivoire
country: Tanzania
responsible party type: Sponsor-Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: Michael Hoelscher
investigator title: Chief Investigator
mesh term: Lamivudine
mesh term: Zidovudine
mesh term: Efavirenz