A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients

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

Summary

The purpose of this study is to see if it is safe and effective to give indinavir sulfate plus stavudine to HIV-infected patients who have already been treated with zidovudine.

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

Details

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

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Prophylaxis with aerosolized pentamidine, topical antifungals, TMP / SMX, dapsone, or isoniazid.

Patients must have:

• HIV infection.

• CD4 count 50 - 500 cells/mm3.

• Prior AZT use for more than 6 months OR documented intolerance to AZT with more than 6 months use of another anti-HIV therapy other than d4T or any protease inhibitor.

• No active opportunistic infection or visceral Kaposi's sarcoma.

NOTE:

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

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Symptomatic neuropathy.

• Acute hepatitis.

Concurrent Medication:

Excluded:

• Antiretrovirals other than specified in protocol.

• Chronic therapy for an active opportunistic infection.

• Immunosuppressive therapy.

Prior Medication:

Excluded:

• Any prior protease inhibitor or d4T.

• Any nucleoside analogs within 2 weeks prior to study entry.

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

Required:

• More than 6 months of prior AZT unless intolerant, in which case more than 6 months of another anti-HIV therapy (other than protease inhibitors or d4T).