The Safety and Effectiveness of Didanosine Plus Stavudine Plus Delavirdine Mesylate Plus MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if it is safe and effective to give MKC-442, didanosine (ddI), stavudine (d4T), and delavirdine (DLV) to HIV-positive patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborators: Pharmacia and Upjohn; Triangle Pharmaceuticals
• Treatments: Delavirdine; Didanosine; Emivirine; HIV Protease Inhibitors; Hydroxyurea; Protease Inhibitors; Stavudine

Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.

• Are at least 18 years old.

• Have experienced treatment failure on a previous anti-HIV drug combination that contained at least one protease inhibitor. Your viral load must be between 5,000 and 50,000 copies/ml after 6 months of continuous treatment with that drug combination.

• Agree to use a barrier method of birth control, such as condoms, during the study.

Exclusion Criteria

You will not be eligible for this study if you:

• Have a history of certain medical conditions, such as pancreatitis, peripheral neuropathy, seizure disorder, or AIDS-related cancer (except for Kaposi's sarcoma).

• Are allergic to any of the study drugs.

• Have ever taken certain anti-HIV medications including non-nucleoside reverse transcriptase inhibitors (NNRTIs), ddI, or d4T.

• Have taken certain other medications including interleukin-2, interferon or a vaccine within 30 days of study entry.

• Have received radiation therapy or chemotherapy within 30 days of study entry. (Local radiation therapy is allowed.)

• Abuse alcohol or drugs.

• Are pregnant or breast-feeding.