The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Nelfinavir mesylate (Drug); Nevirapine (Drug); Stavudine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim
Summary
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.
Clinical Details
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)
Study design: Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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).
Locations and Contacts
Saint Francis Mem Hosp / HIV Care Unit, San Francisco, California 94109, United States
Roger Williams Med Ctr, Providence, Rhode Island 02908, United States
Additional Information
Last updated: June 23, 2005
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