Antiviral Therapy and HIV in the Female Genital Tract
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      HIV is found in both the blood and the genital tract. This study will compare the levels and
      types of HIV found in the blood with the levels and types of HIV found in the female genital
      tract.

      Study hypotheses: 1) In the presence of antiretroviral therapy, viral replication within the
      female genital tract may lead to the development of drug resistance that is different from
      that of virus in the blood plasma. 2) Antiretroviral drug levels in the female genital tract
      may often be lower than in the blood plasma and differences in drug exposure may be
      associated with differences in virus replication and selection of resistant HIV variants
      during drug failure. 3) HIV can be recovered in vitro from cells in the female genital tract
      during successful therapy, and it may be genetically different from the HIV variants
      recovered from the blood cell latent reservoir on the same visit.
    

Detailed description: 
      Approximately 42 million adults are living with HIV/AIDS. The predominant mode of HIV
      transmission worldwide is through heterosexual contact. While many behavioral and biologic
      factors are associated with sexual transmission of HIV, viral load has been identified as the
      chief predictor of the risk of sexual transmission. Research has shown a strong correlation
      between blood plasma viral load and genital tract viral load. Antiretroviral medications can
      reduce blood plasma and genital tract HIV RNA levels, but antiretrovirals also lead to drug
      resistant HIV. In the United States and Europe, 2% to 27% of newly infected patients are
      infected with drug resistant HIV. There are reports of resistant genotypic variants in the
      genital tract that differ from variants found in the blood.

      Understanding the dynamics of HIV in the genital tract is of great importance in strategies
      to control transmission of HIV. This study will evaluate the levels and variants of HIV in
      the blood and genital tracts of women taking antiretroviral medication.

      Both women who are failing their current antiretroviral regimen (Group 1) and those who are
      fully suppressed on antiretroviral therapy (Group 2) will be enrolled in this study. Women in
      Group 1 will have study visits at study entry, 2 weeks after changing medications, then every
      4 weeks until the amount of HIV in the blood and genital tract are undetectable. Drug levels
      in the blood and genital tract will also be measured at the first visit and after changing
      medications. Once the level of HIV is undetectable, women will be seen every 3 months for 36
      months. Women in Group 1 will be followed no more than 42 months. Women in Group 2 will have
      study visits for blood and genital tract collections at study entry and then every 4 weeks
      for 12 months.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-infected women who are failing their current antiretroviral regimen and those who are
        fully suppressed on antiretroviral therapy
      
Biospecimen description: 
      Blood and genital tract collection
    
Keywords: HIV; Women; Genital tract; Treatment experienced; Drug resistance