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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618058
• Other study ID #: IPM 007
• Status: Completed
• Start date: October 4, 2012
• Est. completion date: August 6, 2019

Study information

• Verified date: September 2019
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: August 6, 2019
• Est. primary completion date: August 6, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection

Intervention

Drug:
• No Investigational Product
This study is observational in nature and no investigational product will be used. Groups: ARV-Treated Participants, ARV-Naive Participants

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.

Countries where clinical trial is conducted

Rwanda,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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