HIV-1 Resistance at Screening for HIV Prevention Studies

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Microbicide Trials Network
ClinicalTrials.gov Identifier:
NCT01204814
First received: September 16, 2010
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
HIV
Procedure: Laboratory Testing
Other: Counseling/referral

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Prevalence of HIV-1 Drug Resistance Within a Female Screening Population for HIV Prevention Trials

Resource links provided by NLM:


Further study details as provided by Microbicide Trials Network:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood Plasma


Enrollment: 1074
Study Start Date: August 2010
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV-infected Procedure: Laboratory Testing
Completion of behavorial questionnaire; HIV testing;CD4-positive T cell counts; Plasma viral HIV-1 RNA levels (viral load); Identification of drug resistance mutations in HIV-1 by standard and sensitive assays; Categorization of infection as recent or chronic using current incidence testing algorithms; Follow-up visits with laboratory evaluations
HIV-uninfected Other: Counseling/referral
Completion of behavorial questionnaire; HIV testing; Referred to HIV-prevention trial;

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women of reproductive age who are interested in participating in HIV prevention trials

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204814

Locations
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, Isipingo
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, South Africa
South African Medical Research Council, HIV Prevention Research Unit
Overport, Durban, KwaZulu-Natal, South Africa, 3630
Sponsors and Collaborators
Microbicide Trials Network
Investigators
Study Chair: Urvi Parikh, PhD MTN Virology CORE
  More Information

No publications provided

Responsible Party: Microbicide Trials Network
ClinicalTrials.gov Identifier: NCT01204814     History of Changes
Other Study ID Numbers: MTN-009, 5U01AI068633-04
Study First Received: September 16, 2010
Last Updated: September 5, 2013
Health Authority: South Africa: South African Medical Research Council
United States: Institutional Review Board

Keywords provided by Microbicide Trials Network:
HIV
Drug resistance
mutations
ARV's

ClinicalTrials.gov processed this record on July 28, 2014