A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir

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

Keywords

ClinConnect Summary

All patients receive L-756423 plus indinavir plus two licensed nucleoside reverse transcriptase inhibitors (NRTIs), at least one to which the patient is naive. Patients remain on the drug regimen for 12 weeks (with possible extension to 16 weeks). Patients are evaluated with physical examinations and laboratory tests for blood and urine at Weeks 1, 2, 4, 6, 8, and 12 and two weeks post study. Plasma viral RNA is measured at Weeks 1, 2, 4, 6, 8, and 12. CD4 cell counts are measured at Weeks 2,4,8, and 12.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• You may be eligible for this study if you:
• • Are HIV-positive.
• • Are at least 18 years old.
• • Have a viral load of at least 1,000 copies/ml.
• • Have a CD4 cell count of at least 100 cells/mm3.
• • Have experienced treatment failure (your viral load increased significantly) within 24 weeks of study entry while taking indinavir.
• • Exclusion Criteria
• You will not be eligible for this study if you:
• • Are taking nonnucleoside reverse transcriptase inhibitors (NNRTIs).