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Sponsors and Collaborators: |
University of Alabama at Birmingham Merck |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00734344 |
This is a single-site, investigator-initiated, open-label, randomized/controlled clinical trial to compare the viral load response in plasma (and, in a subset of subjects, in gastrointestinal lymphoid tissue reservoirs) in subjects with acute/early HIV-1 infection treated with 12 weeks of raltegravir-based versus efavirenz-based ART (each combined with tenofovir/emtricitabine). Subjects will receive a self-limited course of therapy rather than a commitment to life-long HAART, as has been the experimental approach in a variety of clinical protocols in the United States and Europe. Subjects will complete a 12 week course of therapy, and those who meet treatment-response and safety criteria will then undergo a similarly intensive period of virology and immunology monitoring to compare the timing and dynamics of any observed virologic rebound following the treatment intervention.
Condition | Intervention | Phase |
---|---|---|
Acute HIV Infection |
Drug: Raltegravir, tenofovir, emtricitibine Drug: Efavirenz plus tenofovir with emtricitibine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Official Title: | Pilot Study of Raltegravir/Tenofovir/Emtricitabine Versus Efavirenz/Tenofovir/Emtricitabine for Adults With Acute HIV-1 Infection: Exploring the Role of Integrase Inhibition in Early HIV Pathogenesis |
Estimated Enrollment: | 20 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Active Comparator
Raltegravir plus Truvada
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Drug: Raltegravir, tenofovir, emtricitibine
Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
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Arm 2: Active Comparator
Efavirenz plus Truvada
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Drug: Efavirenz plus tenofovir with emtricitibine
efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
|
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kerry Upton, RN | 205-975-9128 |
Principal Investigator: | Sonya Heath, M. D. | Department of Medicine Divison of Infectious Disease |
Responsible Party: | UAB Dept. of Medicine, Division of Infectious Disease ( Dr. Sonya Heath ) |
Study ID Numbers: | F080416007 |
Study First Received: | August 12, 2008 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00734344 |
Health Authority: | United States: Institutional Review Board |
Virus Diseases Efavirenz Sexually Transmitted Diseases, Viral Emtricitabine HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Tenofovir Retroviridae Infections Immunologic Deficiency Syndromes Tenofovir disoproxil |
Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |