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

NCT ID: NCT00002418

Last Updated: 2008-08-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL

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.

Conditions

HIV Infections

Keywords

Drug Therapy, Combination; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Emivirine

Intervention Type: DRUG

Hydroxyurea

Intervention Type: DRUG

Nevirapine

Intervention Type: DRUG

Stavudine

Intervention Type: DRUG

Didanosine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are at least 18 years old.
• Are HIV-positive.
• 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 serious medical conditions, including pancreatitis, neuropathy, untreated seizures, or AIDS-related cancers, except Kaposi's sarcoma (KS).
• Are enrolled in another anti-HIV drug study while participating in this study.
• Have ever taken NNRTIs (such as NVP or MKC-442).
• Have ever taken ddI or d4T.
• Have taken certain medications within 30 days prior to study entry, including medications that affect your immune system (such as corticosteroids, interleukin-2, or interferon).
• Abuse alcohol or drugs.
• Have received chemotherapy or radiation therapy within 30 days prior to study entry. (Local radiation therapy is allowed.)
• Are allergic to any of the study drugs.
• Are pregnant or breast-feeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Triangle Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Locations

Pacific Oaks Med Group

Beverly Hills, California, United States

Univ of Colorado / Health Science Ctr

Denver, Colorado, United States

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Brown Univ School of Medicine

Providence, Rhode Island, United States

Hampton Roads Med Specialists

Hampton, Virginia, United States

Countries

United States

Other Identifiers

ICC 601

Identifier Type: -

Identifier Source: secondary_id

292D

Identifier Type: -

Identifier Source: org_study_id