HIV-1 Resistance at Screening for HIV Prevention Studies

HIV Clinical Trial

Official title:

Prevalence of HIV-1 Drug Resistance Within a Female Screening Population for HIV Prevention Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204814
• Other study ID #: MTN-009
• Secondary ID: 5U01AI068633-04
• Status: Completed
• Start date: August 2010
• Est. completion date: July 2011

Study information

• Verified date: June 2021
• Source: Microbicide Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1074
• Est. completion date: July 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
South Africa	South African Medical Research Council, Botha's Hill	Durban	KwaZulu Natal
South Africa	South African Medical Research Council, HIV Prevention Research Unit	Durban	KwaZulu-Natal
South Africa	South African Medical Research Council, Isipingo	Durban	KwaZulu Natal
South Africa	South African Medical Research Council, RK Khan (Chatsworth)	Durban	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	South African Medical Research Council	Tongaat	KwaZulu Natal

Sponsors (2)

Lead Sponsor	Collaborator
Microbicide Trials Network	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

South Africa, 

References & Publications (2)

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. 2 — View 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, Sout — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mutations in HIV-1 reverse transcriptase and protease known to be associated with drug resistance	2 years
Secondary	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	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	2 years
Secondary	• 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	• Plasma HIV-1 RNA levels and CD4-positive T cell counts; Plasma HIV-1 RNA levels and CD4-positive T cell counts	2 years