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

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.

Both microbicide and placebo recipients in IPM 027 who have become HIV infected (HIV-1 or HIV-2) while participating in IPM 027 will be offered enrolment in IPM 007 at the exit visit of IPM 027, i.e. approximately 6 weeks after identification of HIV seroconversion.

This study includes all active IPM clinical research centres that enrol participants for IPM microbicide trials.

• ARV-Treated Participants
  Those participants who received dapivirine during HIV seroconversion
  Intervention: Drug: No Investigational Product
• ARV-Naive Participants
  Those participants who received placebo during HIV seroconversion
  Intervention: Drug: No Investigational Product

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.