Effect Of An Integrase Inhibitor 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 an integrase inhibitor 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 an integrase inhibitor 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 An Integrase Inhibitor On The Latency And Reservoir Of HIV-1 In Patients Taking Highly Active Antiretroviral Therapy|
- To evaluate, by means of a clinical trial, the effect of therapy with an integrase inhibitor (Raltegravir) on the cell reservoir of HIV-1 on patients taking HAART [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Raltegravir (INN), 400 mg tablets, developed and supplied by Merck Sharp & Dohme. A dose of 400 mg will be administered every 12 hours
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807443
|Hospital Universitario Ramon Y Cajal|
|Madrid, Spain, 28034|
|Principal Investigator:||Santiago Moreno Guillen, MD,PhD||HOSPITAL UNIVERSITARIO RAMON Y CAJAL. MADRID|