drugset / Trial / NCT00002124

A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination With Zidovudine (ZDV) Versus ZDV Alone in HIV-1 Infected Individuals With CD4 Counts of 200-500mm3

NCT00002124

Phase 3 Completed 1250 enrolled Pharmacia and Upjohn
Double-blindTreatment

Summary

PART I: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of three fixed doses of delavirdine mesylate (DLV) in combination with zidovudine (AZT) versus AZT alone in HIV-positive patients. PART II: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of ZDV plus 3TC with or without DLV versus ZDV plus DLV in HIV-positive patients.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Delavirdine Small molecule
Subject Lamivudine Other / unclassified
Background Zidovudine Small molecule