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 - Tabular View

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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.

Study NCT00002418. Last updated on August 13, 2008. Information provided by Bristol-Myers Squibb

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	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
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
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.
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Pharmacokinetics Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections
Intervention ^†	Drug: Emivirine Drug: Hydroxyurea Drug: Nevirapine Drug: Stavudine Drug: Didanosine
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Terminated
Enrollment ^†	25
Start Date ^†
Completion Date
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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00002418
Organization ID	292D
Secondary IDs ^††	ICC 601
Study Sponsor ^†	Bristol-Myers Squibb
Collaborators ^††	Boehringer Ingelheim Pharmaceuticals Triangle Pharmaceuticals
Investigators ^†
Information Provided By	Bristol-Myers Squibb
Verification Date	March 2000
First Received Date ^†	November 2, 1999
Last Updated Date	August 13, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.