A Multicenter, Open-Label, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate/d4T/3TC Versus Indinavir Sulfate/Nelfinavir Mesylate/d4T/3TC in HIV-Infected Individuals

Merck Sharp & Dohme LLC46 sites in 1 country220 target enrollmentAugust 31, 2001

ConditionsHIV Infections

DrugsIndinavir sulfate Nelfinavir mesylate Lamivudine Stavudine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HIV Infections
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 220
Locations: 46
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.

Detailed Description

Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.

Registry

clinicaltrials.gov

Start Date

August 31, 2001

End Date

TBD

Last Updated

20 years ago

Study Type

Interventional

Sex

All