A Two Year Study of the Clinical Efficacy of the Combination of Emtricitabine, Tenofovir, and Nevirapine
NCT00344461 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2021-11-01
Summary
Open label, two year study of the clinical efficacy of the combination of FTC, Tenofovir, and Nevirapine. Sixty HIV infected patients without previous exposure to antiretroviral therapy will be enrolled. Study will include a pharmacokinetic substudy to evaluate the interaction of FTC and Nevirapine. Truvada may be used.
Conditions
Interventions
- DRUG
-
Nevirapine, FTC, and Tenofovir
One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.
Sponsors & Collaborators
- collaborator INDUSTRY
-
University of Maryland, Baltimore
lead OTHER
Principal Investigators
-
Robert R Redfield, MD · University of Maryland, School of Medicine, IHV
-
Charles E Davis, MD · University of Maryland, School of Medicine, IHV
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-03-31
- Primary Completion
- 2008-07-31
- Completion
- 2008-07-31
Countries
- United States
Study Locations
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