Observational Study of HIV Infection in Participants of Seroconvert During Dapivirine Vaginal Ring Trials
This study is enrolling participants by invitation only.
Sponsor:
International Partnership for Microbicides, Inc.
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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
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 May 21, 2013