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.
|Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations|
|Patients were recruited at 5 clinical centres in Sydney|
|Significant events and approaches for the overall study following participant enrollment, but prior to group assignment|
|A screening period of less than 42 days prior to commencement of study drugs was employed|
Participant Flow: Overall Study
|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|