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
NCT number | NCT01618058 |
Other study ID # | IPM 007 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 4, 2012 |
Est. completion date | August 6, 2019 |
Verified date | September 2019 |
Source | International Partnership for Microbicides, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
International Partnership for Microbicides, Inc. |
Rwanda, South Africa,
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 |
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