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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Microbicide Trials Network
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Microbicide Trials Network
ClinicalTrials.gov Identifier:
NCT00514098
First received: August 8, 2007
Last updated: September 17, 2014
Last verified: September 2014

August 8, 2007
September 17, 2014
August 2008
November 2020   (final data collection date for primary outcome measure)
HIV disease progression comparison [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To compare HIV disease progression 12 months post seroconversion among participants assigned to an active agent compared to placebo/control participants.
Not Provided
Complete list of historical versions of study NCT00514098 on ClinicalTrials.gov Archive Site
  • HIV disease progression comparison [ Time Frame: Total duration of follow up ] [ Designated as safety issue: No ]
    To compare virologic and immunologic responses following initiation of antiretroviral therapy among participants assigned to an active agent versus placebo/control participants.
  • Virologic and immunologic response comparison [ Time Frame: Total duration of follow up ] [ Designated as safety issue: No ]
    To compare virologic and immunologic responses following initiation of antiretroviral therapy among participants assigned to an active agent versus placebo/control participants.
  • HIV-1 drug resistance profile comparison [ Time Frame: Total duration of follow up ] [ Designated as safety issue: No ]
    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.
  • Sexual behavior and partnership status changes [ Time Frame: Total duration of follow up ] [ Designated as safety issue: No ]
    To describe post seroconversion changes in sexual behaviors and partnership status of participants.
Not Provided
HIV-1 drug resistance mutation evaluation [ Time Frame: Total duration of follow up ] [ Designated as safety issue: No ]
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.
Not Provided
 
Observational Study of HIV Infected Women Previously Enrolled in Other Microbicide Trials
An Observational Cohort Study of Women Following HIV-1 Seroconversion in Microbicide Trials

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood and urine collection, pelvic, vaginal, and cervicovaginal sampling

Probability Sample

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

HIV Infections
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
November 2020
November 2020   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Malawi,   South Africa,   Uganda,   Zambia,   Zimbabwe
 
NCT00514098
MTN-015, 5UM1AI068633, 10529
No
Microbicide Trials Network
Microbicide Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Sharon A. Riddler, MD University of Pittsburgh
Microbicide Trials Network
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP