Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection
Status: | Completed |
---|---|
Conditions: | Infectious Disease, HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 19 - Any |
Updated: | 4/21/2016 |
Start Date: | September 2008 |
End Date: | September 2012 |
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
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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.
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