Effect Of A CCR5 Coreceptor Antagonist On The Latency And Reservoir Of HIV-1
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 viral reservoir prevents antiretroviral therapy from being interrupted; therefore, patients are obliged to continue with treatment for a period calculated to be greater than 60 years.
Despite the important advances in knowledge of the biology of this reservoir, we still have no real knowledge about its dynamics. The opportunity to carry out a clinical trial for the first time with CCR5 coreceptor antagonists is exceptional, since the results could provide important information on the nature of this reservoir.
If maintenance of the reservoir is a dynamic process, inclusion of CCR5 inhibitors is expected to lead to a reduction in the size of this reservoir. This effect could be critical when including IAT (viral reactivation), since, in theory, it would be necessary to act on a smaller reservoir. Current consensus is that it would be necessary to act on almost 100% of the viral reservoir (approximately 1,000,000 cells).
The study has also been designed to enable us to understand the biochemical and molecular mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Pilot Study Of The Effect Of A CCR5 Coreceptor Antagonist On The Latency And Reservoir Of HIV-1 In Patients Taking Highly Active Antiretroviral Therapy|
- Frequency of resting CD4+ T cells infected by a replicative virus [ Time Frame: 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Adult patients with HIV infection and a viral load that has been suppressed for a long period (less than 50 copies/mL for at least 2 years) while on antiretroviral therapy.The treatment group will maintain the habitual antiretroviral therapy combined with maraviroc.
Maraviroc (INN), 300 mg tablets. A dose of 300 mg will be administered every 12 hours.
|Hospital Universitario Ramon Y Cajal|
|Madrid, Spain, 28034|
|Principal Investigator:||Santiago Moreno Guillen, MD,PhD||HOSPITAL UNIVERSITARIO RAMON Y CAJAL. MADRID|