A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients
Overview
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.
Full Title of Study: “One Year Study in HIV-1 Seropositive, AZT-Experienced Patients to Evaluate the Safety and Efficacy of MK-639 Administered Concomitantly With Stavudine (d4T)”
Study Type
- Study Type: Interventional
- Study Design
- Primary Purpose: Treatment
- Masking: Double
Interventions
- Drug: Indinavir sulfate
- Drug: Stavudine
Participating in This Clinical Trial
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).
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Merck Sharp & Dohme LLC
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