Status:
COMPLETED
Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Acute HIV Infection
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Subjects 19 years of age or older who meet the NIH Acute Infection and Early Disease Research Program (AIEDRP) definition of acute or early HIV-1 infection. Briefly, acute HIV-1 infection is defined as \> 5000 copies per milliliter of HIV RNA and one of the following documented within a 7 day period of the initial positive PCR-based assay: 1) a negative HIV-1 EIA or 2) a positive EIA with a negative or indeterminant HIV-1 Western Blot test (interpreted based on current CDC guidelines). For the purposes of this protocol, early HIV-1 infection is defined as detectable HIV RNA by PCR-based assay, a positive HIV EIA, a positive HIV-1 Western blot, and one of the following: 1) a documented negative HIV EIA in the preceding 6 months or 2) an HIV detuned EIA standardized optical density measurement (defined as sample OD - negative control OD/ positive control OD) of \< 1.0 within 14 days of the positive HIV EIA (consistent with acute infection occurring in the past 120 days).
Exclusion
- Lack consistent evidence of seroconversion or documented appropriate antibody testing for persistent HIV infection during the screening and early follow-up period.
- Prior receipt of antiretroviral therapy.
- Serum creatinine \> 2.0 x upper limit of normal or a calculated creatinine clearance at time of screening \< 30 mL/min (and 0.85X this value for females).
- Alkaline phosphatase \>5 x upper limit of normal.
- AST (SGOT) and ALT (SGPT) \> 5 x upper limit of normal. Repeat of a laboratory screening test will be allowed for test results that are unexpected based on documented prior laboratory results or to monitor declining trends that may relate to the primary retroviral syndrome.
- Have any severe medical illness that the investigators feel will interfere with the ability to take therapy or that will result in making therapy too risky for the subject. This includes active tuberculosis treatment, severe liver disease due to alcoholism or viral hepatitis, or unstable cardiovascular or cerebrovascular disease.
- Have significant psychiatric illness or ongoing substance abuse that, in the opinion of the investigators, would compromise the ability of the subject to provide adequate informed consent or to adhere to the study procedures safely and consistently.
- Women who are pregnant or actively breastfeeding at the time of screening.
- Men or women who are actively attempting to become pregnant, or who are unable or unwilling to institute adequate birth control measures during the entire course of this treatment protocol.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00734344
Start Date
September 1 2008
End Date
September 1 2012
Last Update
May 30 2016
Active Locations (1)
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1
UAB 1917 Clinic
Birmingham, Alabama, United States, 35294