Clinical trial NCT01204814: HIV-1 Resistance at Screening for HIV Prevention Studies
Official title: Prevalence of HIV-1 Drug Resistance Within a Female Screening Population for HIV Prevention Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV
Drug resistance
mutations
ARV's
Lead sponsor: Microbicide Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2010-09-17
Enrollment: 1074
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women of reproductive age who are interested in participating in HIV prevention trials

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: 2 years
measure: • 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
timeFrame: 2 years
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: South African Medical Research Council, Botha's Hill
state: KwaZulu Natal
city: Durban
country: South Africa
facility: South African Medical Research Council, Isipingo
state: KwaZulu Natal
city: Durban
country: South Africa
facility: South African Medical Research Council, RK Khan (Chatsworth)
state: KwaZulu Natal
city: Durban
country: South Africa
facility: South African Medical Research Council, Umkomaas
state: KwaZulu Natal
city: Durban
country: South Africa
facility: South African Medical Research Council, Verulam
state: KwaZulu Natal
city: Tongaat
country: South Africa
facility: South African Medical Research Council
state: KwaZulu Natal
city: Durban
country: South Africa
facility: South African Medical Research Council, HIV Prevention Research Unit
state: KwaZulu-Natal
Study officials:
affiliation: MTN Virology CORE
name: Urvi Parikh, PhD
role: STUDY_CHAIR
References:
citation: Parikh UM, Kiepiela P, Ganesh S, Gomez K, Horn S, Eskay K, Kelly C, Mensch B, Gorbach P, Soto-Torres L, Ramjee G, Mellors JW; MTN-009 Protocol Team. Prevalence of HIV-1 drug resistance among women screening for HIV prevention trials in KwaZulu-Natal, South Africa (MTN-009). PLoS One. 2013 Apr 9;8(4):e59787. doi: 10.1371/journal.pone.0059787. Print 2013.
citation: Mensch BS, Gorbach PM, Kelly C, Kiepiela P, Gomez K, Ramjee G, Ganesh S, Morar N, Soto-Torres L, Parikh UM. Characteristics Associated with HIV Drug Resistance Among Women Screening for an HIV Prevention Trial in KwaZulu-Natal, South Africa. AIDS Behav. 2015 Nov;19(11):2076-86. doi: 10.1007/s10461-015-1056-4.