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Observational Study of HIV Infected Women Previously Enrolled in Other Microbicide Trials
This study is currently recruiting participants.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), August 2008
Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Microbicide Trials Network
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00514098
  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

MedlinePlus related topics: AIDS
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: An Observational Cohort Study of Women Following HIV-1 Seroconversion in Microbicide Trials

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

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

Click here for the Microbicide Trials Network Web site  This link exits the ClinicalTrials.gov site
Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site

Publications:
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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Microbicide
Seroconversion
Treatment Experienced
Treatment Naive

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009