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

Completed

• Conditions: HIV Infections
• Interventions: Drug: No Investigational Product

• Registration Number: NCT01618058
• Lead Sponsor: International Partnership for Microbicides, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-13
• Study Start: 2012-10-04
• Primary Completion: 2019-08-06
• Study Completion: 2019-08-06
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 151

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ARV-Treated Participants	No Investigational Product	Those participants who received dapivirine during HIV seroconversion
ARV-Naive Participants	No Investigational Product	Those participants who received placebo during HIV seroconversion

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (5)

Prevention for HIV and AIDS Project (PHIVA); 🇿🇦 Pinetown, Kwazulu Natal, South Africa

Maternal, Adolescent and Child Health (MatCH); 🇿🇦 Plessislaer, South Africa

Project Ubuzima; 🇷🇼 Kiyovu, Kigali, Rwanda

Qhakaza Mbokodo; 🇿🇦 Ladysmith, Kwazulu Natal, South Africa

Madibeng Centre for Research (MCR); 🇿🇦 Brits, South Africa