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: February 9, 2014
Last verified: December 2012
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: September 2008
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Raltegravir plus Truvada
Drug: Raltegravir, tenofovir, emtricitibine
Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
Active Comparator: Arm 2
Efavirenz plus Truvada
Drug: Efavirenz plus tenofovir with emtricitibine
efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734344

Locations
United States, Alabama
UAB 1917 Clinic
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Sonya Heath, M. D. Department of Medicine Divison of Infectious Disease
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00734344     History of Changes
Other Study ID Numbers: F080416007
Study First Received: August 12, 2008
Last Updated: February 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir
Tenofovir disoproxil
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 16, 2014