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
|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.|
|ClinicalTrials.gov Identifier: NCT00002418|
Recruitment Status : Terminated
First Posted : August 31, 2001
Last Update Posted : August 14, 2008
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|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Emivirine Drug: Hydroxyurea Drug: Nevirapine Drug: Stavudine Drug: Didanosine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||25 participants|
|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|
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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.
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
|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|
|Other Study ID Numbers:||
|First Posted:||August 31, 2001 Key Record Dates|
|Last Update Posted:||August 14, 2008|
|Last Verified:||March 2000|
Drug Therapy, Combination
Reverse Transcriptase Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers