Antiviral Therapy and HIV in the Female Genital Tract

Completed

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID: NCT00067106
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 130
Starts: 2003-07-01
Expected to finish: 2009-03-01
Last updated by the study team: 2015-05-19

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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:
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

You may not qualify if…

Women not on antiretroviral therapy

Where it is running

The Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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