Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients

Launched by MERCK SHARP & DOHME LLC · Aug 30, 2001

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• You may be eligible for this study if you:
• • Are HIV-positive.
• • Have a CD4 count of at least 100 cells/mm3.
• • Have a plasma viral load (level of HIV in the blood) of at least 30,000 copies/ml.
• • Are at least 18 years old.
• • Exclusion Criteria
• You will not be eligible for this study if you:
• • Have ever been treated with any protease inhibitors (PIs).