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

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ClinicalTrials.gov Identifier: NCT00514098
Recruitment Status : Recruiting
First Posted : August 9, 2007
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
HIV Infections

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 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.


Study Design

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: An Observational Cohort Study of Women Following HIV-1 Seroconversion in Microbicide Trials
Study Start Date : August 2008
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. HIV disease progression comparison [ Time Frame: 12 months ]
    To compare HIV disease progression 12 months post seroconversion among participants assigned to an active agent compared to placebo/control participants.


Secondary Outcome Measures :
  1. HIV disease progression comparison [ Time Frame: Total duration of follow up ]
    To compare virologic and immunologic responses following initiation of antiretroviral therapy among participants assigned to an active agent versus placebo/control participants.

  2. Virologic and immunologic response comparison [ Time Frame: Total duration of follow up ]
    To compare virologic and immunologic responses following initiation of antiretroviral therapy among participants assigned to an active agent versus placebo/control participants.

  3. HIV-1 drug resistance profile comparison [ Time Frame: Total duration of follow up ]
    To compare the HIV-1 drug resistance profile, among antiretroviral therapy recipients at the time of virologic failure in participants assigned to an active agent versus placebo/control participants.

  4. Sexual behavior and partnership status changes [ Time Frame: Total duration of follow up ]
    To describe post seroconversion changes in sexual behaviors and partnership status of participants.


Other Outcome Measures:
  1. HIV-1 drug resistance mutation evaluation [ Time Frame: Total duration of follow up ]
    To evaluate the prevalence and persistence of HIV-1 drug resistance mutations in plasma and/or genital tract specimens after HIV-1 seroconversion using both standard and sensitive methods in specific subgroups of seroconverters.


Biospecimen Retention:   Samples With DNA
Blood and urine collection, pelvic, vaginal, and cervicovaginal sampling

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, PhD, MBChB         
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 Completed
Johannesburg, Guateng, South Africa, 2571
CAPRISA eThewkini Recruiting
Durban, KwaZulu Natal, South Africa, 4001
Contact: Nesri Padayatchi       padayatchin@ukzn.ac.za   
South African Medical Research Council, Tongaat Recruiting
Durban, KwaZulu Natal, South Africa
Contact: Sharika Gappoo    27-31-242-3645    sharika.gappoo@mrc.ac.za   
Botha's Hill CRS Recruiting
Durban, KwaZulu-Natal, South Africa, 3660
Contact: Zola Msiska    27-31-2423600    zmsiska@mrc.ac.za   
Overport CRS Completed
Durban, KwaZulu-Natal, South Africa, 4091
Isipingo CRS Recruiting
Durban, KwaZulu-Natal, South Africa, 4133
Contact: Elaine Smith    27-31-2423600    esmith@mrc.ac.za   
Verulam CRS Recruiting
Durban, KwaZulu-Natal, South Africa, 4390
Contact: Zakir Gaffoor    27-32-5334145    Zakir.gaffoor@mrc.ac.za   
Umkomaas CRS Recruiting
Durban, KwaZulu-Natal, South Africa
Contact: Brodie Daniels    27-31-2423600    bdaniels@mrc.ac.za   
Perinatal HIV Research Unit (HPRU) Completed
Johannesburg, Soweto, South Africa, 1804
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 Completed
Kamwala, Zambia
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
National Institute of Allergy and Infectious Diseases (NIAID)
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
5UM1AI068633 ( U.S. NIH Grant/Contract )
10529 ( Other Grant/Funding Number: DAIDS Protocol ID )
First Posted: August 9, 2007    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by Microbicide Trials Network:
Microbicide
Seroconversion
Treatment Experienced
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Infective Agents