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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00734344
First received: August 12, 2008
Last updated: August 18, 2014
Last verified: August 2014

August 12, 2008
August 18, 2014
September 2008
August 2012   (final data collection date for primary outcome measure)
RNA, CBC and CD4 results [ Time Frame: All CBC, CD4 and safety labs realtime, RNA results realtime at least every 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00734344 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute HIV Infection
  • Drug: Raltegravir, tenofovir, emtricitibine
    Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
  • Drug: Efavirenz plus tenofovir with emtricitibine
    efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
  • Active Comparator: Arm 1
    Raltegravir plus Truvada
    Intervention: Drug: Raltegravir, tenofovir, emtricitibine
  • Active Comparator: Arm 2
    Efavirenz plus Truvada
    Intervention: Drug: Efavirenz plus tenofovir with emtricitibine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00734344
F080416007
No
University of Alabama at Birmingham
University of Alabama at Birmingham
Merck Sharp & Dohme Corp.
Principal Investigator: Sonya Heath, M. D. Department of Medicine Divison of Infectious Disease
University of Alabama at Birmingham
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP