Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection

NCT ID: NCT00734344

Last Updated: 2016-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-09-30

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 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.

Conditions

Acute HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

Raltegravir plus Truvada

Group Type: ACTIVE_COMPARATOR

Raltegravir

Intervention Type: DRUG

Raltegravir 400 mg. BID

Emtricitibine

Intervention Type: DRUG

200mg once daily

Tenofovir disoproxil twice daily

Intervention Type: DRUG

300mg twice daily

Arm 2

Efavirenz plus Truvada

Group Type: ACTIVE_COMPARATOR

Efavirenz

Intervention Type: DRUG

600 mg once daily

Emtricitibine

Intervention Type: DRUG

200mg once daily

Tenofovir disoproxil once daily

Intervention Type: DRUG

300mg once daily

Interventions

Raltegravir

Raltegravir 400 mg. BID

Intervention Type: DRUG

Efavirenz

600 mg once daily

Intervention Type: DRUG

Emtricitibine

200mg once daily

Intervention Type: DRUG

Tenofovir disoproxil once daily

300mg once daily

Intervention Type: DRUG

Tenofovir disoproxil twice daily

300mg twice daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Sonya Heath, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sonya Heath, M. D.

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine Divison of Infectious Disease

Locations

UAB 1917 Clinic

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

F080416007

Identifier Type: -

Identifier Source: org_study_id