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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 : Active, not recruiting
First Posted : August 9, 2007
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Microbicide Trials Network

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.


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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
Actual Study Start Date : June 25, 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




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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

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
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Malawi
College of Med. JHU CRS
Blantyre, Malawi
University of North Carolina Lilongwe
Lilongwe, Malawi
South Africa
Wits Reproductive Health Institute (WRHI)
Johannesburg, Gauteng, South Africa, 2001
CAPRISA- The Aurum Institute
Johannesburg, Guateng, South Africa, 2571
CAPRISA eThewkini
Durban, KwaZulu Natal, South Africa, 4001
South African Medical Research Council, Tongaat
Durban, KwaZulu Natal, South Africa
Botha's Hill CRS
Durban, KwaZulu-Natal, South Africa, 3660
Overport CRS
Durban, KwaZulu-Natal, South Africa, 4091
Isipingo CRS
Durban, KwaZulu-Natal, South Africa, 4133
Verulam CRS
Durban, KwaZulu-Natal, South Africa, 4390
Umkomaas CRS
Durban, KwaZulu-Natal, South Africa
Perinatal HIV Research Unit (HPRU)
Johannesburg, Soweto, South Africa, 1804
R. K. Khan CRS
Durban, South Africa
Uganda
Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS
Kampala, Uganda
Zambia
Kamwala Clinic CRS
Kamwala, Zambia
Zimbabwe
UZ-UCSF HIV Prevention Trials Unit
Harare, Chitungwiza, Zimbabwe
Seke South CRS
Chitungwiza, Zimbabwe
Spilhaus CRS
Harare, Zimbabwe
Sponsors and Collaborators
Microbicide Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Chair: Sharon A. Riddler, MD University of Pittsburgh

Additional Information:
Publications:
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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: September 25, 2019
Last Verified: July 2019
Keywords provided by Microbicide Trials Network:
Microbicide
Seroconversion
Treatment Experienced
Treatment Naive
Additional relevant MeSH terms:
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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