Completed

Pharmacokinetic Interaction Study of Nevirapine and Nelfinavir in HIV-1 Infected Adults Treated with Stavudine

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What is being tested

Nelfinavir mesylate

+ Nevirapine

+ Stavudine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

From 18 to 65 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorBoehringer Ingelheim
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002381
Principal SponsorBoehringer Ingelheim
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

4 inclusion criteria required to participate
Plasma HIV-1 RNA >= 5000 copies/ml.
Documented HIV infection.
CD4+ cell count >= 100 cells/mm3.
Previous antiretroviral therapy with zidovudine, lamivudine, didanosine, and dideoxycytidine.
12 exclusion criteria prevent from participating
Investigational drugs within 30 days of first dose of study medication.
Hepatic insufficiency due to cirrhosis.
Radiotherapy, other than local skin radiotherapy treatment, within 12 weeks prior to study.
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.
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Saint Francis Mem Hosp / HIV Care Unit

San Francisco, United StatesOpen Saint Francis Mem Hosp / HIV Care Unit in Google Maps

Roger Williams Med Ctr

Providence, United States
Completed2 Study Centers