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

Phase 2

Terminated

• Conditions: HIV Infections

• Registration Number: NCT00002418
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus MKC-442. Hydroxyurea (HU) may be added.

Detailed Description

Patients receive a regimen of didanosine, stavudine, nevirapine, and MKC-442 for 24 weeks. Throughout the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. Patients who experience virologic failure have the option of adding hydroxyurea to their treatment regimen or discontinuing from the study. After Week 24, patients with documented virologic response may continue treatment with didanosine, stavudine, nevirapine, and MKC-442, and, if applicable, hydroxyurea until a change in virologic status occurs (i.e., the patient experiences virologic failure). Follow-up visits are conducted every 4 to 12 weeks until permanent discontinuation from the study.

Study Timeline

• Study First Submitted: 1999-11-02
• Status Verified: 2000-03
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2008-08-13
• Last Update Posted: 2008-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

Univ of Colorado / Health Science Ctr; 🇺🇸 Denver, Colorado, United States

Brown Univ School of Medicine; 🇺🇸 Providence, Rhode Island, United States

AIDS Research Consortium of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Pacific Oaks Med Group; 🇺🇸 Beverly Hills, California, United States

Hampton Roads Med Specialists; 🇺🇸 Hampton, Virginia, United States