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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

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ClinicalTrials.gov Identifier: NCT00002418
Recruitment Status : Terminated
First Posted : August 31, 2001
Last Update Posted : August 14, 2008
Boehringer Ingelheim
Triangle Pharmaceuticals
Information provided by:
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.

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002418

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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
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ClinicalTrials.gov Identifier: NCT00002418    
Other Study ID Numbers: 292D
ICC 601
First Posted: August 31, 2001    Key Record Dates
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:
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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