Observational Study of HIV Infection in Participants of Seroconvert During Dapivirine Vaginal Ring Trials

September 5, 2019 updated by: International Partnership for Microbicides, Inc.

A Long-Term Observational Cohort Study of HIV Infection in Participants Who Seroconvert After Enrolment in Dapivirine Vaginal Ring Trials

The purpose of this trial is to determine if exposure to ARV-containing investigational products in IPM clinical trials will impact the natural history of HIV infection as measured by the virologic, immunologic and clinical outcomes of participants who become HIV-positive during the IPM 027 trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

151

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
    • Kigali
      • Kiyovu, Kigali, Rwanda
        • Project Ubuzima
  • South Africa
      • Brits, South Africa, 0250
        • Madibeng Centre for Research (MCR)
      • Plessislaer, South Africa, 3216
        • Maternal, Adolescent and Child Health (MatCH)
    • Kwazulu Natal
      • Ladysmith, Kwazulu Natal, South Africa
        • Qhakaza Mbokodo
      • Pinetown, Kwazulu Natal, South Africa
        • Prevention for HIV and AIDS Project (PHIVA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Both microbicide and placebo recipients in IPM 027 who have become HIV infected (HIV-1 or HIV-2) while participating in IPM 027 will be offered enrolment in IPM 007 at the exit visit of IPM 027, i.e. approximately 6 weeks after identification of HIV seroconversion.

This study includes all active IPM clinical research centres that enrol participants for IPM microbicide trials.

Description

Inclusion Criteria:

  • Recent HIV seroconversion during participation in IPM 027, according to the HIV testing algorithm of that trial
  • Ability and willingness to provide informed consent
  • Willingness to give the research centre permission to share information with the primary health care provider (PHCP), and willingness to sign approved site-specific documentation to facilitate such sharing.

Exclusion Criteria:

  • Any condition that, in the opinion of the Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ARV-Treated Participants
Those participants who received dapivirine during HIV seroconversion
Drug: No Investigational Product

This study is observational in nature and no investigational product will be used.

Groups: ARV-Treated Participants, ARV-Naive Participants
ARV-Naive Participants
Those participants who received placebo during HIV seroconversion
Drug: No Investigational Product

This study is observational in nature and no investigational product will be used.

Groups: ARV-Treated Participants, ARV-Naive Participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To identify HIV drug resistant mutations following recent seroconversion in plasma and vaginal secretions and change in resistant mutations over time in participants previously exposed to an ARV-based microbicide or a placebo.
Time Frame: 12 months
The primary outcome will be assessed by viral genotype assay at baseline and at exit from the protocol, to assess the occurrence and frequency of acquiring a drug resistant HIV virus during follow-up.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Partnership for Microbicides, Inc.

Investigators

  • Study Chair: Linda-Gail Bekker, Desmond Tutu HIV Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2012

Primary Completion (Actual)

August 6, 2019

Study Completion (Actual)

August 6, 2019

Study Registration Dates

First Submitted

June 8, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (Estimate)

June 13, 2012

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 5, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPM 007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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