Trial record 2 of 37 for:    " May 30, 2012":" June 29, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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 Intervention
HIV Infections
Drug: No Investigational Product

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 68
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618058

Locations
Rwanda
Project Ubuzima
Kiyivu, 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 Foundation
  More Information

No publications provided

Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT01618058     History of Changes
Other Study ID Numbers: IPM 007
Study First Received: June 8, 2012
Last Updated: August 20, 2012
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 28, 2014