The Safety and Effectiveness of MK-639 and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

• Status: Completed
• Trial end date: 1996-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the effects on CD4 counts and safety of MK-639 (indinavir, IDV) and AZT administered concomitantly to MK-639 alone and AZT alone in HIV-1 seropositive patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Indinavir; Zidovudine

Criteria

Inclusion Criteria

Patients must have:

• HIV seropositivity.

• Average CD4 count between 50 and 500 cells/mm3 based on 2 separate pre-study determinations at least 1 week apart.

Note:

• Patients with known hemophilia may be enrolled at the discretion of the investigator.

Prior Medication:

Excluded:

• Any protease inhibitor.

• Significant prior use (greater than 2 weeks) of nucleoside analogues.

• Chronic therapy for an active opportunistic infection. (Allowed:

• Prophylaxis with aerosolized pentamidine, trimethoprim/sulfamethoxazole, dapsone, topical antifungals, and isoniazid).

• Investigational agents or immunomodulators within 30 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Acute hepatitis.

• Lymphoma.

• Visceral Kaposi's sarcoma.

• Invasive cervical cancer.

• Active infection.

Concurrent Medication:

Excluded:

Anticipated immunosuppressive therapy.