HIV Infections
Conditions
Keywords
Drug Therapy, Combination, HIV Protease Inhibitors, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Brief summary
The purpose of this study is to see if L-756423, an anti-HIV drug, is safe to give with indinavir and if it works well at lowering the level of HIV in the blood (viral load).
Detailed description
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.
Interventions
DRUGL-756423
DRUGIndinavir sulfate
Sponsors
Merck Sharp & Dohme LLC
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Countries
United States
Outcome results
None listed