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

International Partnership for Microbicides (IPM)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: No Investigational Product

Study type: Observational

Funder types: Industry

Identifiers

NCT01618058

IPM 007

Details and patient eligibility

About

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.

Enrollment: 151 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

151 participants in 2 patient groups

ARV-Treated Participants

Description:

Those participants who received dapivirine during HIV seroconversion

Treatment:

Drug: No Investigational Product

ARV-Naive Participants

Description:

Those participants who received placebo during HIV seroconversion

Treatment:

Drug: No Investigational Product