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

• ClinicalTrials.gov Identifier: NCT00002418
• Recruitment Status: Terminated
• First Posted: August 31, 2001
• Last Update Posted: August 14, 2008
• Sponsor: Bristol-Myers Squibb
• Collaborators: Boehringer Ingelheim; Triangle Pharmaceuticals
• Information provided by: Bristol-Myers Squibb

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Emivirine; Drug: Hydroxyurea; Drug: Nevirapine; Drug: Stavudine; Drug: Didanosine	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 25 participants
• Primary Purpose: Treatment
• Official Title: A Phase II, 24-Week, Open-Label Study Designed to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Novel Combination Therapy With Videx (Didanosine), Zerit (Stavudine), Viramune (Nevirapine), and MKC-442 (With or Without Hydroxyurea) for the Treatment of HIV-1 Infection in Non-Nucleoside Reverse Transcriptase Inhibitor Naive Patients Who Failed Previous Protease Inhibitor Treatment

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

Pacific Oaks Med Group

Beverly Hills, California, United States, 90211

United States, Colorado

Univ of Colorado / Health Science Ctr

Denver, Colorado, United States, 80262

United States, Georgia

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States, 30308

United States, Rhode Island

Brown Univ School of Medicine

Providence, Rhode Island, United States, 02908

United States, Virginia

Hampton Roads Med Specialists

Hampton, Virginia, United States, 23666

Sponsors and Collaborators

Bristol-Myers Squibb

Boehringer Ingelheim

Triangle Pharmaceuticals

More Information

• ClinicalTrials.gov Identifier: NCT00002418
• Other Study ID Numbers: 292D; ICC 601
• First Posted: August 31, 2001
• Last Update Posted: August 14, 2008
• Last Verified: March 2000

Keywords provided by Bristol-Myers Squibb:

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

Additional relevant MeSH terms:

Infections; Nevirapine; Didanosine; Stavudine; Emivirine; Hydroxyurea; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents; Anti-HIV Agents; Anti-Retroviral Agents; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 Enzyme Inducers; Antineoplastic Agents; Antisickling Agents; Antimetabolites