HIV in the Female Genital Tract

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00067106
First received: August 11, 2003
Last updated: September 25, 2008
Last verified: September 2008

August 11, 2003
September 25, 2008
July 2003
March 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00067106 on ClinicalTrials.gov Archive Site
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HIV in the Female Genital Tract
Antiviral Therapy and HIV in the Genital Tract of Women

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.

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
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Blood and genital tract collection

Non-Probability Sample

HIV-infected women who are failing their current antiretroviral regimen and those who are fully suppressed on antiretroviral therapy

HIV Infections
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  • 1
    Participants 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. Participants in Group 1 will be followed no more than 42 months.
  • 2
    Participants will have study visits for blood and genital tract collections at study entry and then every 4 weeks for 12 months
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
March 2009
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria for Women Responding to Antiretroviral Medication Regimen

  • HIV-infected
  • Viral load below detectable limits for at least 6 months prior to study entry
  • Have not failed an antiretroviral regimen or have failed only one previous antiretroviral regimen

Inclusion Criteria for Women Failing Antiretroviral Medication Regimen

  • HIV-infected
  • Viral load more than 1,000 copies/ml on at least two occasions, with one viral load more than 10,000 copies/ml
  • Expect to change to a new antiretroviral regimen
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00067106
AI04350
Not Provided
Susan Cu-Uvin, MD, The Miriam Hospital, Brown Medical School
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Susan Cu-Uvin, MD The Miriam Hospital, Brown Medical School
National Institute of Allergy and Infectious Diseases (NIAID)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP