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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
HIV |
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 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 |

- 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
- 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
- • 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

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 |
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

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
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 |
Study Chair: | Urvi Parikh, PhD | MTN Virology CORE |
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 |