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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

151 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-04

Study Completion Date

2019-08-06

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ARV-Treated Participants

Those participants who received dapivirine during HIV seroconversion

No Investigational Product

Intervention Type DRUG

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

No Investigational Product

Intervention Type DRUG

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

Groups: ARV-Treated Participants, ARV-Naive Participants

Interventions

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No Investigational Product

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

Groups: ARV-Treated Participants, ARV-Naive Participants

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No