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

Start Over

Newton Kumwenda, MPH, PhD

College of Med. JHU CRS
Blantyre, Malawi

Francis Martinson, PhD, MBChB

University of North Carolina Lilongwe
Lilongwe, Malawi

Helen Rees

Wits Reproductive Health Institute (WRHI)
Johannesburg, South Africa

CAPRISA- The Aurum Institute
Johannesburg, South Africa

Nesri Padayatchi

CAPRISA eThewkini
Durban, South Africa

Sharika Gappoo

South African Medical Research Council, Tongaat
Durban, South Africa

Zola Msiska

Botha's Hill CRS
Durban, South Africa

Overport CRS
Durban, South Africa

Elaine Smith

Isipingo CRS
Durban, South Africa

Zakir Gaffoor

Verulam CRS
Durban, South Africa

Brodie Daniels

Umkomaas CRS
Durban, South Africa

Perinatal HIV Research Unit (HPRU)
Johannesburg, South Africa

Nicola Coumi

R. K. Khan CRS
Durban, South Africa

Philippa Musoke, MD

Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS
Kampala, Uganda

Kamwala Clinic CRS
Kamwala, Zambia

Nyaradzo Mgodi

UZ-UCSF HIV Prevention Trials Unit
Harare, Zimbabwe

Thulani Magwali, MD

Seke South CRS
Chitungwiza, Zimbabwe

Tsitsi Magure, MB ChB, MMED

Spilhaus CRS
Hirare, Zimbabwe

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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