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

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ClinicalTrials.gov Identifier: NCT01618058
Recruitment Status : Enrolling by invitation
First Posted : June 13, 2012
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.

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.

Condition or disease Intervention/treatment
HIV Infections Drug: No Investigational Product

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Long-Term Observational Cohort Study of HIV Infection in Participants Who Seroconvert After Enrolment in Dapivirine Vaginal Ring Trials
Study Start Date : June 2012
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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

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

Groups: ARV-Treated Participants, ARV-Naive Participants





Primary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618058


Locations
Rwanda
Project Ubuzima
Kiyovu, Kigali, Rwanda
South Africa
Qhakaza Mbokodo
Ladysmith, Kwazulu Natal, South Africa
Prevention for HIV and AIDS Project (PHIVA)
Pinetown, Kwazulu Natal, South Africa
Madibeng Centre for Research (MCR)
Brits, South Africa, 0250
Maternal, Adolescent and Child Health (MatCH)
Plessislaer, South Africa, 3216
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Chair: Linda-Gail Bekker Desmond Tutu HIV Centre

Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT01618058     History of Changes
Other Study ID Numbers: IPM 007
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Keywords provided by International Partnership for Microbicides, Inc.:
HIV Infections
Anti-HIV Agents
HIV-1

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases