Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00002375
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to see if it is safe and effective to treat HIV-infected patients with indinavir (IDV) plus nelfinavir (NFV), 2 anti-HIV medications.
It is thought that IDV plus NFV will be a safe drug combination for treating HIV.
- Detailed Description
It is hypothesized that the administration of indinavir with nelfinavir will be generally safe and well tolerated.
This is a parallel, time-lagged, 2-stage, multiple-dose, 24-week study in HIV-1 seropositive patients. In the 3-week, randomized, double-blind phase of Stage A, patients receive either indinavir plus nelfinavir (Group A1: 9 patients) or indinavir placebo plus nelfinavir placebo (Group A2: 3 patients) for the first week. In Week 2, patients in Group A1 have the nelfinavir dose increased. This dose escalation for nelfinavir is contingent upon the patient having completed 1 week of the study drugs without experiencing Grade 3 or worse toxicity and/or serious drug-related adverse events. Patients in Group A2 continue to receive placebo until Week 3, at which time they receive indinavir plus nelfinavir (initial dose), while patients in Group A1 continue with indinavir plus nelfinavir (escalated dose). At Week 4 all patients in Stage A (including those originally assigned to receive placebo) receive open-label indinavir plus nelfinavir (escalated dose) for the remainder of the 24 weeks.
After at least 6 patients in Stage A have completed at least 2 weeks of therapy with nelfinavir plus indinavir with acceptable tolerability, Stage B begins. In the 2-week, randomized, double-blind phase of Stage B, patients receive either indinavir plus nelfinavir (Group B1: 9 patients) or indinavir placebo plus nelfinavir placebo (Group B2, 3 patients). After 2 weeks, all patients in Stage B (including those originally assigned to receive placebo) receive open-label indinavir plus nelfinavir for the remainder of the 24 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
UCSD Treatment Ctr / Dept of Medicine and Pediatrics
🇺🇸San Diego, California, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Univ of Pittsburgh / Graduate School of Public Health
🇺🇸Pittsburgh, Pennsylvania, United States