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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Nelfinavir mesylate
Drug: Nevirapine
Drug: Stavudine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 24
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002381

Locations
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
Sponsors and Collaborators
Boehringer Ingelheim
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002381     History of Changes
Other Study ID Numbers: 200F, 1100.1224
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Drug Therapy, Combination
Nevirapine
Stavudine
RNA, Viral
Nelfinavir
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Nevirapine
Stavudine
Nelfinavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Antimetabolites
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on September 14, 2014