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

Launched by MERCK SHARP & DOHME LLC · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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).