HIV-1 Resistance at Screening for HIV Prevention Studies

Completed

• Conditions: HIV

• Registration Number: NCT01204814
• Lead Sponsor: Microbicide Trials Network

Brief Summary

MTN-009 is a multi-site, cross-sectional study that will provide an estimate of the prevalence of ARV resistance in the population of women who present to study sites to be pre-screened or screened for participation in an HIV prevention trial. To date, a comprehensive surveillance of HIV drug resistance in newly diagnosed women of reproductive age has yet to be undertaken. The primary goal of MTN-009 is to assess the frequency of HIV drug resistance mutations among women who test HIV-positive when presenting to screen for participation in HIV prevention trials.

Detailed Description

MTN-009 is a multi-site, cross-sectional study that will provide an estimate of the prevalence of ARV resistance in the population of women who present to study sites to be pre-screened or screened for participation in an HIV prevention trial. To date, a comprehensive surveillance of HIV drug resistance in newly diagnosed women of reproductive age has yet to be undertaken. The primary goal of MTN-009 is to assess the frequency of HIV drug resistance mutations among women who test HIV-positive when presenting to screen for participation in HIV prevention trials. Secondary aims include the identification and evaluation of behavioral indicators including self or sexual partner(s) exposures to antiretroviral (ARV) drugs as risk factors for drug resistant HIV infection, as well as the 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 aims include 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.

The finding of significant resistance, or lack thereof, to ARV-based study products delivered vaginally or taken orally may guide decisions related to future microbicide and PrEP studies. In addition, MTN-009 will provide valuable comparison data for the resistance data obtained in MTN-015, the MTN seroconverter study.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-17
• Primary Completion: 2011-03
• Study Completion: 2011-07
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-17
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1074

Inclusion Criteria

• Present to an MTN-009 study site to pre-screen or screen for an HIV prevention trial
• Age 18-40 years, verified per site standard operating procedures (SOP)
• Able and willing to provide written informed consent for participation in MTN-009
• Able and willing to provide adequate locator information, as defined in site SOPs

Exclusion Criteria

• Any condition that, in the investigator's opinion, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achievement of the study objectives

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the frequency of HIV drug resistance mutations among women who test HIV-positive when presenting to screen for participation in HIV prevention trials	2 years	Mutations in HIV-1 reverse transcriptase and protease known to be associated with drug resistance

Secondary Outcome Measures

Name	Time	Method
To identify and evaluate behavioral indicators including self or sexual partner(s) exposures to ARV drugs as risk factors for drug resistant HIV infection in women who present for screening to participate in HIV prevention trials	2 years	Participant self-reported ARV drug exposures and other behaviors or herself or sexual partner(s) that may be associated with risk of drug resistant HIV-1 infections
• To characterize 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 for screening to participate in HIV prevention trials	2 years	• Plasma HIV-1 RNA levels and CD4-positive T cell counts; Plasma HIV-1 RNA levels and CD4-positive T cell counts

Trial Locations

Locations (7)

South African Medical Research Council, Isipingo; 🇿🇦 Durban, KwaZulu Natal, South Africa

South African Medical Research Council, Botha's Hill; 🇿🇦 Durban, KwaZulu Natal, South Africa

South African Medical Research Council, RK Khan (Chatsworth); 🇿🇦 Durban, KwaZulu Natal, South Africa

South African Medical Research Council, HIV Prevention Research Unit; 🇿🇦 Durban, KwaZulu-Natal, South Africa

South African Medical Research Council; 🇿🇦 Tongaat, KwaZulu Natal, South Africa

South African Medical Research Council, Umkomaas; 🇿🇦 Durban, KwaZulu Natal, South Africa

South African Medical Research Council, Verulam; 🇿🇦 Durban, KwaZulu Natal, South Africa