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Sponsors and Collaborators: |
Bristol-Myers Squibb Boehringer Ingelheim Pharmaceuticals Triangle Pharmaceuticals |
Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00002418 |
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 II |
MedlinePlus related topics: | AIDS AIDS Medicines |
ChemIDplus related topics: | Didanosine Stavudine Hydroxyurea Nevirapine MKC 442 |
Study Type: | Interventional |
Study Design: | Treatment, Pharmacokinetics Study |
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 |
Estimated Enrollment: | 25 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
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 |
Bristol-Myers Squibb |
Boehringer Ingelheim Pharmaceuticals |
Triangle Pharmaceuticals |
Study ID Numbers: | 292D, ICC 601 |
First Received: | November 2, 1999 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00002418 |
Health Authority: | United States: Food and Drug Administration |
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