CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed
Drug / intervention
Indinavir sulfate +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00000841
NCT00000841Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Phase III Study of Indinavir Sulfate With Open-Label Zidovudine (AZT) and Lamivudine (3TC) in Subjects With HIV Infection With CD4 Cell Counts <= 200 Cells/mm3 and >= 6 Months of Prior AZT Experience

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 31, 2001·Updated Nov 4, 2021

In Brief

A Phase 3 clinical trial evaluating Indinavir sulfate, Lamivudine, and 2 other interventions for HIV Infections. Completed, across 87 sites in 2 countries.

Detailed Summary

To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients. Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2001
Study CompletionJun 1, 1997
TodayJul 2, 2026
Posted 24.8 years ago

Interventions

Indinavir sulfatedrug

Lamivudinedrug

Stavudinedrug

Zidovudinedrug