ClinicalTrials.gov
ClinicalTrials.gov Menu

HIV-1 Resistance at Screening for HIV Prevention Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01204814
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Microbicide Trials Network

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
HIV

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 Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 1074 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Prevalence of HIV-1 Drug Resistance Within a Female Screening Population for HIV Prevention Trials
Study Start Date : August 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
    Mutations in HIV-1 reverse transcriptase and protease known to be associated with drug resistance


Secondary Outcome Measures :
  1. 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 ]
    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. • 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 ]

    • Plasma HIV-1 RNA levels and CD4-positive T cell counts

    Plasma HIV-1 RNA levels and CD4-positive T cell counts



Biospecimen Retention:   Samples With DNA
Blood Plasma

Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204814


Locations
South Africa
South African Medical Research Council, Botha's Hill
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, South Africa
South African Medical Research Council, HIV Prevention Research Unit
Durban, KwaZulu-Natal, South Africa, 3630
Sponsors and Collaborators
Microbicide Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Urvi Parikh, PhD MTN Virology CORE
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Microbicide Trials Network
ClinicalTrials.gov Identifier: NCT01204814     History of Changes
Other Study ID Numbers: MTN-009
5U01AI068633-04 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: April 2015

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