HIV Infections
Conditions
Keywords
Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Nelfinavir
Brief summary
The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.
Detailed description
Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.
Interventions
DRUGIndinavir sulfate
DRUGNelfinavir mesylate
DRUGLamivudine
DRUGStavudine
Sponsors
Merck Sharp & Dohme LLC
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
You may be eligible for this study if you: * Are HIV positive. * Have a viral load (level of HIV in your blood) of at least 10,000 copies/ml within 45 days of study entry. * Have a CD4 cell count of at least 100 cells/mm3 within 45 days of study entry. * Have a normal chest X-ray. * Have never taken protease inhibitors or 3TC. * Are 16 years of age or older. * Agree to practice sexual abstinence or use barrier methods of birth control (e.g., condoms).
Exclusion criteria
You will not be eligible for this study if you: * Have an active opportunistic (AIDS-related) infection or cancer. * Have certain types of Kaposi's sarcoma. * Have hepatitis. * Have chronic diarrhea. * Have a history of certain medical conditions. * Are allergic to any of the study medications. * Are taking certain medications. * Are pregnant or breast-feeding.
Countries
United States
Outcome results
None listed