The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine
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|ClinicalTrials.gov Identifier: NCT00002381|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Nelfinavir mesylate Drug: Nevirapine Drug: Stavudine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||24 participants|
|Masking:||None (Open Label)|
|Official Title:||An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (Viramune) and Nelfinavir (Viracept) and the Efficacy of This Combination Therapy in HIV-1 Infected Adults Treated With Stavudine [d4T] (Zerit)|
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have:
- Documented HIV infection.
- CD4+ cell count >= 100 cells/mm3.
- Plasma HIV-1 RNA >= 5000 copies/ml.
Previous antiretroviral therapy with zidovudine, lamivudine, didanosine, and dideoxycytidine.
Patients with the following symptoms and conditions are excluded:
- Malabsorption, severe chronic diarrhea, or the inability to maintain adequate oral intake.
- Undergoing treatment for an active infection.
- Hepatic insufficiency due to cirrhosis.
1. Systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 14 days of entry. Substances in these categories include:
- macrolide antibiotics (erythromycin, clarithromycin, azithromycin, dirithromycin), azole antifungals (ketoconazole, fluconazole, itraconazole), rifampin, rifabutin, and phenytoin.
- Previous exposure to non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as delavirdine, loviride, DMP 266, or nevirapine and/or protease inhibitors (PI) such as saquinavir, ritonavir, indinavir, and nelfinavir.
- > 6 months previous exposure to d4T.
- Investigational drugs within 30 days of first dose of study medication.
- Any antineoplastic agent within 12 weeks before starting study medication.
Radiotherapy, other than local skin radiotherapy treatment, within 12 weeks prior to study.
1. History of intravenous drug abuse or alcohol or substance abuse considered by the Investigator and BIPI Medical Monitor to be a significant impairment to health and compliance.
- Heavy smokers (e.g., > 20 cigarettes per day).
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): NCT00002381
|United States, California|
|Saint Francis Mem Hosp / HIV Care Unit|
|San Francisco, California, United States, 94109|
|United States, Rhode Island|
|Roger Williams Med Ctr|
|Providence, Rhode Island, United States, 02908|
|Other Study ID Numbers:||
|First Posted:||August 31, 2001 Key Record Dates|
|Last Update Posted:||June 24, 2005|
|Last Verified:||August 2002|
Drug Therapy, Combination
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
HIV Protease Inhibitors
Viral Protease Inhibitors