Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Indinavir; Lamivudine; Ritonavir; Stavudine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Have a CD4 cell count of 75 cells/mm3 or more and a viral load of 5,000 copies/ml or more.

• Are age 16 or older (consent of a parent or guardian required if under 18).

• Agree to practice abstinence or use barrier methods of birth control (such as condoms).

• Are willing to stop taking all anti-HIV drugs except study drugs. (Patients may be able to continue taking drugs for other infections.)

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have cancer, lung disease, severe hepatitis, or active AIDS-related infections. (Certain AIDS-related infections such as Kaposi's sarcoma may be allowed).

• Have ever taken 3TC, abacavir (ABC), or a protease inhibitor (such as IDV or RTV).

• Have changed their medications in the last 2 weeks.

• Are allergic to IDV, RTV, d4T, or 3TC.

• Have used certain medications (see the technical summary for more detail).

• Are pregnant or breast-feeding.