Status:
WITHDRAWN
Immune Responses in Patients Treated With Raltegravir
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
Hypothesis: Treatment with raltegravir does not alter V(D)J recombination or immune responses to neoantigens. A process known as V(D)J recombination is essential for developing lymphocytes and the sp...
Detailed Description
V(D)J recombination is essential for developing lymphocytes and the specific functioning of the immune system. Germline gene coding segments become rearranged to create functional immunoglobulin and T...
Eligibility Criteria
Inclusion
- HIV-1 infected males, as determined by ELISA and Western blot;
- \>18 years of age;
- Current ARV therapy with efavirenz + Truvada® for \>52 weeks;
- HIV-1 RNA (bDNA) \<50 copies/ml for at least 52 weeks;
- No history of hepatitis A vaccine, and HAV antibody negative.
Exclusion
- any immunomodulatory therapy within 24 weeks of screening or during the trial;
- any type of vaccine within 24 weeks of screening or during the trial;
- current opportunistic infection, malignancy, acute infection, or febrile illness;
- history of hypersensitivity to a vaccine, components of a vaccine, or components of a vaccine container.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00785967
Start Date
January 1 2009
End Date
August 1 2011
Last Update
April 14 2015
Active Locations (1)
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1
Immune Deficiency Treatment Centre, Montreal General Hospital, McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4