Last updated on March 2019

Observational Study of HIV Infected Women Previously Enrolled in Other Microbicide Trials


Brief description of study

A new approach to HIV prevention currently being studied includes the use of topical microbicides and orally administered anti-HIV drugs. The purpose of this study is to better understand the impact of microbicides in women who are diagnosed with HIV-1 during participation in previous microbicide trials.

Detailed Study Description

It is necessary to monitor HIV over long periods of time in order to better understand the impact of microbicides and anti-HIV drugs on the progression of HIV infection in those who become infected or are unknowingly already infected while receiving these drugs. The purpose of this study is to determine the effects of microbicides or oral anti-HIV drugs over time in HIV infected women who were previously enrolled in other microbicide trials.

The study will remain open to accrual for the duration of MTN funding, and will use two follow-up visit schedules, one based on the date of diagnosis in the parent study, and one based on the initiation of antiretroviral treatment (ART). Participants who have not initiated ART at the time of enrollment in this study will follow the schedule based on the date of diagnosis. Participants who have already begun ART at the time of enrollment will follow the schedule based on the date of ART initiation. Individuals enrolled with a starting date based on the date of ART initiation will have their first follow-up visit at Week 2 before resuming the rest of the schedule. On both schedules, follow-up visits occur at Months 1, 3, and 6 and every 6 months thereafter. Interim visits may be performed at any time during follow-up, and participants will be asked to attend a final study visit prior to their termination from the study. Participants may enroll any time after their HIV diagnosis and can leave the study at any time.

A physical exam; medical and medication history assessment; blood and urine collection; and pelvic, cervicovaginal lavage, and vaginal swab sampling will occur at all visits. A behavioral assessment will occur at select visits, and adherence and social harms assessments will occur at most visits. Sexually transmitted infection risk reduction/contraception and HIV-1 secondary counseling will occur at most visits. In addition, condoms will be provided at all visits to reduce further HIV transmission. ART will not be provided by this study.

Clinical Study Identifier: NCT00514098

Contact Investigators or Research Sites near you

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College of Med. JHU CRS

Blantyre, Malawi

Wits Reproductive Health Institute (WRHI)

Johannesburg, South Africa

CAPRISA- The Aurum Institute

Johannesburg, South Africa

CAPRISA eThewkini

Durban, South Africa

Botha's Hill CRS

Durban, South Africa

Overport CRS

Durban, South Africa

Isipingo CRS

Durban, South Africa

Verulam CRS

Durban, South Africa

Umkomaas CRS

Durban, South Africa

Perinatal HIV Research Unit (HPRU)

Johannesburg, South Africa

R. K. Khan CRS

Durban, South Africa

Kamwala Clinic CRS

Kamwala, Zambia

Seke South CRS

Chitungwiza, Zimbabwe

Spilhaus CRS

Hirare, Zimbabwe

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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