Status:
COMPLETED
Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV-1
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with a viral load below 50 copies/mL is the main limitation to eradication of the virus from the body. This vira...
Eligibility Criteria
Inclusion
- After receiving information on the design and objectives of the study, the possible risks involved, and the fact that they can refuse to collaborate at any time, patients will give their informed consent to participate in the study and agree to provide material for the cellular and molecular studies.
- Aged over 18 years.
- Chronic HIV infection
- Antiretroviral therapy with at least 3 drugs for at least 2 years and with no modifications expected during the study. Antiretroviral drugs can be switched due to intolerance as long as plasma viremia remains controlled.
- Undetectable viral load determined by ultrasensitive techniques (\<50 copies HIV RNA/mL) for at least 2 years.
- CD4+ T lymphocyte count above 350 cells/mm3.
- Understand the objective of the study and be available to make frequent visits to the hospital.
Exclusion
- Previous failure of antiretroviral therapy, understood as a rebound in viral load that can be detected after having reached undetectable levels. Low-grade increases (\<200 copies of HIV RNA/mL) and transitory increases (blips) resolved without modifying antiretroviral therapy are excluded.
- Proven resistance against the antiretroviral drugs under study.
- Planned interruption of antiretroviral therapy.
- Taking immunosuppressive or immunostimulating medication of any type, including valproic acid.
- Taking a fusion inhibitor (enfuvirtide).
- Pregnancy or intention to become pregnant during the study.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00807443
Start Date
September 1 2009
End Date
December 1 2011
Last Update
February 1 2013
Active Locations (1)
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1
Hospital Universitario Ramon Y Cajal
Madrid, Madrid, Spain, 28034