The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection (PINT)
This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
CSajjadi, Kirby Institute
First received: February 28, 2008
Last updated: May 23, 2013
Last verified: May 2013
Results First Received: April 11, 2012
|Study Design:||Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment|
Drug: Tenofovir + emtricitabine + raltegravir.
|Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.|
|No text entered.|
Number of Participants
|Between 18 and 65 years||16|
Region of Enrollment
|1. Primary:||Mean Change From Baseline Plasma HIV RNA (Log Copies/mL) [ Time Frame: 12 times within 48 weeks. ]|
Limitations and Caveats
|Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data|
|Limited cohort (n=16) of exclusively male participants treated with a licensed regimen of combination antiretroviral therapy with the primary focus being a detailed examination of virus decay characteristics|