A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: Stavudine; Drug: Lamivudine; Drug: Zidovudine; Drug: Indinavir sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002208

069-00

246M

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.