HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy
This study is designed to determine how quickly HIV-1 is cleared from the blood in treatment-experienced patients beginning a salvage therapy regimen that includes the integrase inhibitor raltegravir. The hypothesis is that HIV-1 is cleared as rapidly in these patients as in treatment-naive patients starting a raltegravir-based regimen.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy|
- first- and second-phase decay rates of plasma HIV-1 RNA [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- 1. As exploratory analyses, to compare the observed first-phase decay rate of plasma HIV-1 RNA in treatment-experienced patients receiving raltegravir to treatment-naïve patients in other studies. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- 2. Quantify changes in the intracellular levels of HIV-1 proviral DNA and LTR circles during raltegravir therapy. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- 3. Correlate changes in the intracellular DNA compartments with first- and second-phase plasma HIV-1 RNA clearance rates. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Peripheral blood mononuclear cells will be tested for HIV-1 DNA levels. The cell pellets obtained from each of the samples will be tested for 1) total HIV-1 DNA and 2-LTR circles using real-time quantitative PCR and 2) integrated proviral DNA using Alu real-time nested PCR.
|Study Start Date:||June 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
antiretroviral-experienced patients requiring raltegravir to construct an adequately potent antiretroviral regimen.
Other: blood drawing
Subjects will have been prescribed raltegravir (400 mg BID) by their primary physicians. Such subjects will have frequent blood sampling in this study to monitor the virologic response to raltegravir therapy.
This pilot study will closely examine the viral dynamics of both HIV-1 RNA and DNA in treatment-experienced subjects initiating raltegravir. The data derived from this study will further elucidate the effects of antiviral therapy on viral decay and help refine current viral dynamics models. In addition, results of this study will generate hypotheses for further testing regarding the mechanisms of action of integrase inhibitor therapy in salvage regimens. Lastly, this viral dynamic study on a unique cohort will provide an opportunity to further validate the effectiveness of the methods of measuring rate of decrease of viral RNA and DNA in piloting potential potent drug regimens.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709397
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Daniel R Kuritzkes, MD||Brigham and Women's Hospital|