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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