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).
