HIV Infections
Conditions
Keywords
HIV Infections, Anti-HIV Agents, HIV-1
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.
Interventions
This study is observational in nature and no investigational product will be used. Groups: ARV-Treated Participants, ARV-Naive Participants
Sponsors
International Partnership for Microbicides, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Rwanda, South Africa
Outcome results
None listed