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

One Year Study in HIV-1 Seropositive, AZT-Experienced Patients to Evaluate the Safety and Efficacy of MK-639 Administered Concomitantly With Stavudine (d4T)

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.

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).