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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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002418
First Posted: August 31, 2001
Last Update Posted: August 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Boehringer Ingelheim
Triangle Pharmaceuticals
Information provided by:
Bristol-Myers Squibb
  Purpose
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 Intervention Phase
HIV Infections Drug: Emivirine Drug: Hydroxyurea Drug: Nevirapine Drug: Stavudine Drug: Didanosine Phase 2

Study Type: Interventional
Study Design: 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 NLM:


Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment: 25
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


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     History of Changes
Other Study ID Numbers: 292D
ICC 601
First Submitted: November 2, 1999
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:
Infection
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Protease Inhibitors
HIV Protease Inhibitors
Nevirapine
Reverse Transcriptase Inhibitors
Stavudine
Didanosine
Emivirine
Hydroxyurea
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Antineoplastic Agents
Antisickling Agents
Antimetabolites