Based in part on these results, AZT was selected by nucleoside chemist Janet Rideout as one of 11 compounds to send to the NCI for testing in that organizations HIV antiviral assay.In February 1985, the NCI scientists found that AZT had potent efficacy in vitro. Several months later, a phase 1 clinical trial of AZT at the NCI was initiated at the NCI and Duke University,. In doing this Phase I trial, they built on their experience in doing an earlier trial, with suramin, another drug that had shown effective anti-HIV activity in the laboratory. This initial trial of AZT proved that the drug could be safely administered to patients with HIV, that it increased their CD4 counts, restored T cell immunity as measured by skin testing, and that it showed strong evidence of clinical effectiveness, such as inducing weight gain in AIDS patients. It also showed that levels of AZT that worked in vitro could be injected into patients in serum and suppository form, and that the drug penetrated deeply only into infected brains. Patent filed and FDA approval
A rigorous double-blind, placebo-controlled randomized trial of AZT was subsequently conducted by Burroughs-Wellcome and proved that AZT safely prolongs the lives of people with HIV. Burroughs-Wellcome filed for a patent for AZT in 1985. The Anti-Infective Advisory Committee to United States Food and Drug Administration (FDA) voted ten to one to recommend the approval of AZT.
The fluid is drained by gravity, a syringe, or by connection to a vacuum bottle. Several litres of fluid may be drained during the procedure; however, if more than two litres are to be drained, it will usually be done over the course of several treatments. After the desired level of drainage is complete, the plastic sheath is removed and the puncture site bandaged. The plastic sheath can be left in place with a flow control valve and protective dressing if further treatments are expected to be necessary.If fluid drainage in cirrhotic ascites is more than 5 litres, patients may receive intravenous serum albumin (25% albumin, 8g/L) to prevent hypotension (low blood pressure). There has been debate as to whether albumin administration confers benefit, but a recent 2016 meta-analysis concluded that it can reduce mortality after large-volume paracentesis significantly. However, for every end-point investigated, while albumin was favorable as compared to other agents (e.g., plasma expanders, vasoconstrictors), these were not statistically significant and the meta-analysis was limited by the quality of the studies — two of which that were in fact unsuitable — included in it.The procedure generally is not painful and does not require sedation. The patient is usually discharged within several hours following post-procedure observation provided that blood pressure is otherwise normal and the patient experiences no dizziness. Fluid analysis
The serum-ascites albumin gradient can help determine the cause of the ascites.The ascitic white blood cell count can help determine if the ascites is infected.