Microbicide Trials Network

MTN-009

Details

Protocol Title: 
Prevalence of HIV-1 Drug Resistance within a Female Screening Population for HIV Prevention Trials
DAIDS Protocol ID: 
10791
Status: 
Participants off Study and Primary Analysis Completed

Protocol Chair(s)

Photini Kiepiela (Protocol Co-Chair)
Urvi Parikh (Protocol Co-Chair)

Description

MTN-009 was a multi-site, cross-sectional study that provided an estimate of the prevalence of antiretroviral (ARV) drug resistance mutations in the population of women who present to study sites to be pre-screened or screened for participation in an HIV prevention trial. Limited data exist on the prevalence of HIV infection or HIV drug resistance among individuals who are potential users of ARV-based prevention products. Secondary objectives included: 1) the identification and evaluation of behavioral indicators including self or sexual partner(s) exposures to ARV drugs as risk factors for drug resistant HIV infection; and 2) characterization of the degree of immunodeficiency and risk of disease progression by quantifying plasma HIV-1 RNA and CD4-positive T cells among women who test HIV-positive when presenting to screen for participation in an HIV prevention trial.  Exploratory objectives included the identification of polymorphic or subtype-specific sequence changes in HIV-1 that may impact susceptibility to ARVs and the estimation of the proportion of HIV-positive women who have chronic versus recent HIV infection. Preliminary results were presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI), March 5-8, 2012 in Seattle WA.

Other Study Info

Sponsor:

Division of AIDS, US National Institute of Allergy and Infectious Diseases

US National Institutes of Health