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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT01618058
First received: June 8, 2012
Last updated: August 20, 2012
Last verified: August 2012

June 8, 2012
August 20, 2012
June 2012
December 2015   (final data collection date for primary outcome measure)
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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01618058 on ClinicalTrials.gov Archive Site
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Observational Study of HIV Infection in Participants of Seroconvert During Dapivirine Vaginal Ring Trials
A Long-Term Observational Cohort Study of HIV Infection in Participants Who Seroconvert After Enrolment in 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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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.

HIV Infections
Drug: No Investigational Product

This study is observational in nature and no investigational product will be used.

Groups: ARV-Treated Participants, ARV-Naive Participants

  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
68
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
South Africa,   Rwanda
 
NCT01618058
IPM 007
Yes
International Partnership for Microbicides, Inc.
International Partnership for Microbicides, Inc.
Not Provided
Study Chair: Linda-Gail Bekker Desmond Tutu HIV Foundation
International Partnership for Microbicides, Inc.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP