A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC
- Conditions
- HIV Infections
- Registration Number
- NCT00002208
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
To demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease inhibitor- and 3TC-naive HIV-1-seropositive patients. To characterize the steady-state pharmacokinetic profiles of indinavir, ZDV (or d4T), and 3TC in the presence of each other, for both the control and test regimen groups.
- Detailed Description
Patients are randomized to 1 of 2 arms:
Arm A: Indinavir plus ZDV plus 3TC. Arm B: Indinavir (test dose) plus ZDV plus 3TC. NOTE: d4T may be substituted for zidovudine for toxicity management. Patients are stratified based on prior use of nucleoside analogs (naive vs experienced to ZDV, dideoxyinosine \[ddI\], dideoxycytidine \[ddC\], and d4T) and screening viral RNA results (lower than 50,000 copies/mL vs more than 50,000 copies/mL).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
LAC/USC Med Ctr
🇺🇸Los Angeles, California, United States
Kaiser Med Ctr
🇺🇸San Francisco, California, United States
Wilmington Hosp / Med Ctr of Delaware
🇺🇸Wilmington, Delaware, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Washington Univ
🇺🇸St. Louis, Missouri, United States
Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit
🇺🇸Stony Brook, New York, United States
Scroll for more (5 remaining)Univ of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States