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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Microbicide Trials Network |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00514098 |
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.
Condition |
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HIV Infections |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | An Observational Cohort Study of Women Following HIV-1 Seroconversion in Microbicide Trials |
Blood and urine collection, pelvic, vaginal, and cervicovaginal sampling
Estimated Enrollment: | 500 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
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 last until May 31, 2013, 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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Women who are diagnosed with HIV-1 during participation in previous microbicide trials
Inclusion Criteria:
Exclusion Criteria:
Malawi | |
College of Med. JHU CRS | Recruiting |
Blantyre, Malawi | |
Contact: Stacey Hurst 265-8-204404 shurst@jhu.medcol.mw | |
Principal Investigator: Newton Kumwenda, MPH, PhD | |
University of North Carolina Lilongwe | Recruiting |
Lilongwe, Malawi | |
Contact: Kimberly Reynolds 265-1-755954 kreynolds@unclilongwe.org.mw | |
Principal Investigator: Francis Martinson, MPH, PhD, MB ChB | |
South Africa | |
R. K. Khan CRS | Recruiting |
Durban, South Africa | |
Contact: Kodwa Mpepho 27-31-2423600 kodwa.mpepho@mrc.ac.za | |
Principal Investigator: Nicola Coumi | |
Zambia | |
Kamwala Clinic CRS | Recruiting |
Kamwala, Zambia | |
Contact: Cheri Reid, BSN, MPH 260-21-1293661 ext 141 cheri.reid@cidrz.org | |
Principal Investigator: Muzala Kapina, MD, ChB | |
Zimbabwe | |
Seke South CRS | Recruiting |
Chitungwiza, Zimbabwe | |
Contact: Margaret Mlingo 263-4-2915421 margaret@uz-ucsf.co.zw | |
Principal Investigator: Thulani Magwali, MD | |
Spilhaus CRS | Recruiting |
Hirare, Zimbabwe | |
Contact: Margaret Mlingo 263-4-2915421 margaret@uz-ucsf.co.zw | |
Principal Investigator: Tsitsi Magure, MB ChB, MMED |
Study Chair: | Sharon A. Riddler, MD | University of Pittsburgh |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | MTN-015, 1-U01-AI068633-01 |
Study First Received: | August 8, 2007 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00514098 |
Health Authority: | United States: Federal Government |
Microbicide Seroconversion Treatment Experienced Treatment Naive |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |