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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Microbicide Trials Network.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Microbicide Trials Network
ClinicalTrials.gov Identifier:
NCT00514098
First received: August 8, 2007
Last updated: August 24, 2011
Last verified: August 2011
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Microbicide Trials Network:

Biospecimen Retention:   Samples With DNA

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)
Detailed 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 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women who are diagnosed with HIV-1 during participation in previous microbicide trials

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514098

Locations
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         
Sponsors and Collaborators
Microbicide Trials Network
Investigators
Study Chair: Sharon A. Riddler, MD University of Pittsburgh
  More Information

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 July 23, 2014