HIV Infections
Conditions
Keywords
HIV-1, Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors
Brief summary
To demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease inhibitor- and 3TC-naive HIV-1-seropositive patients. To characterize the steady-state pharmacokinetic profiles of indinavir, ZDV (or d4T), and 3TC in the presence of each other, for both the control and test regimen groups.
Detailed description
Patients are randomized to 1 of 2 arms: Arm A: Indinavir plus ZDV plus 3TC. Arm B: Indinavir (test dose) plus ZDV plus 3TC. NOTE: d4T may be substituted for zidovudine for toxicity management. Patients are stratified based on prior use of nucleoside analogs (naive vs experienced to ZDV, dideoxyinosine \[ddI\], dideoxycytidine \[ddC\], and d4T) and screening viral RNA results (lower than 50,000 copies/mL vs more than 50,000 copies/mL).
Interventions
DRUGIndinavir sulfate
DRUGLamivudine
DRUGStavudine
DRUGZidovudine
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
Patients must have: * HIV-1 seropositive status. * CD4 count greater than 100 cells/mm3. * Viral RNA above 10,000 copies/mL. * Consent from parent or guardian if less than 18 years of age.
Exclusion criteria
Prior Medication: Excluded: * Prior therapy with protease inhibitors. * Prior therapy with 3TC.
Countries
United States
Outcome results
None listed