Observational Study of HIV Infected Women Previously Enrolled in Other Microbicide Trials
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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 |
---|
HIV Infections |
Study Type: | Observational |
Study Design: | Observational Model: Case Control Time Perspective: 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 2012 (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.
![](https://webarchive.library.unt.edu/web/20130317081449im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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:
- Diagnosis of HIV-1 infection during participation in any Microbicide Trials Network (MTN) clinical trial (including HPTN 035 and HPTN 059), according to the HIV testing algorithm of the parent MTN trial
- Parent or guardian willing to provide informed consent, if applicable
Exclusion Criteria:
- Any condition that, in the opinion of the investigator, makes participation in the study unsafe or interferes with the study
![](https://webarchive.library.unt.edu/web/20130317081449im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 | |
Wits Reproductive Health Institute (WRHI) | Recruiting |
Johannesburg, Gauteng, South Africa, 2001 | |
Contact: Helen Rees 27 11 358-5344 hrees@rhru.co.za | |
CAPRISA- The Aurum Institute | Recruiting |
Johannesburg, Guateng, South Africa, 2571 | |
Contact: Gavin Churchyard 27 10 590 1301 gchurchyard@auruminstitute.org | |
South African Medical Research Council, Tongaat | Recruiting |
Durban, KwaZulu Natal, South Africa | |
Contact: Sharika Gappoo 27-31-242-3645 sharika.gappoo@mrc.ac.za | |
CAPRISA eThewkini | Recruiting |
Durban, KwaZulu Natal, South Africa, 4001 | |
Contact: Nesri Padayatchi padayatchin@ukzn.ac.za | |
Botha's Hill CRS | Recruiting |
Durban, KwaZulu-Natal, South Africa, 3660 | |
Contact: Zola Msiska 27-31-2423600 zmsiska@mrc.ac.za | |
Isipingo CRS | Recruiting |
Durban, KwaZulu-Natal, South Africa, 4133 | |
Contact: Elaine Smith 27-31-2423600 esmith@mrc.ac.za | |
Umkomaas CRS | Recruiting |
Durban, KwaZulu-Natal, South Africa | |
Contact: Brodie Daniels 27-31-2423600 bdaniels@mrc.ac.za | |
Overport CRS | Recruiting |
Durban, KwaZulu-Natal, South Africa, 4091 | |
Contact: Samantha Sukhdeo 27-31-2084535 Samantha.sukhdeo@mrc.ac.za | |
Verulam CRS | Recruiting |
Durban, KwaZulu-Natal, South Africa, 4390 | |
Contact: Zakir Gaffoor 27-32-5334145 Zakir.gaffoor@mrc.ac.za | |
Perinatal HIV Research Unit (HPRU) | Recruiting |
Johannesburg, Soweto, South Africa, 1804 | |
Contact: Baningi Mkhize 27 11 989 9705 mkhizeb@phru.co.za | |
R. K. Khan CRS | Recruiting |
Durban, South Africa | |
Contact: Kodwa Mpepho 27-31-2423600 kodwa.mpepho@mrc.ac.za | |
Principal Investigator: Nicola Coumi | |
Uganda | |
Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS | Recruiting |
Kampala, Uganda | |
Contact: Philippa Musoke, MD 256-41-541044 pmusoke@mujhu.org | |
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 | |
UZ-UCSF HIV Prevention Trials Unit | Recruiting |
Harare, Chitungwiza, Zimbabwe | |
Contact: Nyaradzo Mgodi 263 912 264 616 nmmgodi@uz-ucsf.co.zw | |
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 |
![](https://webarchive.library.unt.edu/web/20130317081449im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
Publications:
Responsible Party: | Microbicide Trials Network |
ClinicalTrials.gov Identifier: | NCT00514098 History of Changes |
Other Study ID Numbers: | MTN-015, 5U01AI068633, 1-U01-AI068633-01 |
Study First Received: | August 8, 2007 |
Last Updated: | August 24, 2011 |
Health Authority: | United States: Federal Government |
Keywords provided by Microbicide Trials Network:
Microbicide Seroconversion Treatment Experienced Treatment Naive |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 14, 2013