The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002381
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 2002

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002381 on ClinicalTrials.gov Archive Site
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The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine
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)

To determine the potential effects of 28 days of nevirapine treatment on the steady-state pharmacokinetics of nelfinavir and of stavudine (d4T), and to further evaluate the pharmacokinetics of nevirapine in combination with nelfinavir, and d4T compared to the historical controls treated with nevirapine but without nelfinavir or d4T. To determine the efficacy of long-term combination therapy of nevirapine, nelfinavir and d4T on viral load in patients who are non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor naive, and have <= 6 months prior d4T exposure at the time of screening.

The trial is an open-label study in patients with HIV-1 infection who are naive to treatment with NNRTI and protease inhibitor classes of antiretroviral drugs and have <= 6 months prior exposure to d4T at the time of screening. Part I of this trial is an investigation of potential pharmacokinetic interaction between nevirapine and nelfinavir in HIV-1-infected adults treated with d4T. Part II is an investigation of the long-term antiviral activity of the combination of nevirapine and nelfinavir on viral load as measured by HIV-1 RNA.

Interventional
Phase 1
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Nelfinavir mesylate
  • Drug: Nevirapine
  • Drug: Stavudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
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Inclusion Criteria

Patients must have:

  • Documented HIV infection.
  • CD4+ cell count >= 100 cells/mm3.
  • Plasma HIV-1 RNA >= 5000 copies/ml.

Prior Medication:

Allowed:

Previous antiretroviral therapy with zidovudine, lamivudine, didanosine, and dideoxycytidine.

Exclusion Criteria

Co-existing Condition:

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.
  • Renal insufficiency.

    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).
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002381
200F, 1100.1224
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Boehringer Ingelheim
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NIH AIDS Clinical Trials Information Service
August 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP