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

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

Sponsors

Lead sponsor: Merck Sharp & Dohme Corp.

Source NIH AIDS Clinical Trials Information Service
Brief Summary

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.

Overall Status Completed
Phase N/A
Study Type Interventional
Enrollment 540
Condition
Intervention

Intervention type: Drug

Intervention name: Indinavir sulfate

Intervention type: Drug

Intervention name: Stavudine

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).

Gender: All

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: No

Location
facility Merck & Co Inc
Location Countries

United States

Verification Date

January 1996

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Primary purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov