Status:
COMPLETED
Effect Of A CCR5 Coreceptor Antagonist On The Latency And Reservoir Of HIV-1
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborating Sponsors:
Pfizer
Conditions:
HIV-1
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.
- Demonstration of R5 viral tropism (use of CCR5 coreceptors) by phenotyping in plasma samples stored before antiretroviral therapy is started.
- 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 :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00795444
Start Date
March 1 2008
End Date
January 1 2015
Last Update
January 26 2015
Active Locations (1)
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1
Hospital Universitario Ramon Y Cajal
Madrid, Madrid, Spain, 28034