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

NCT01618058 | Completed DMC

• 1 other identifier: IPM 007
• Study Type: observational
• Target: 151
• Locations: 2 countries
• Sites: 5

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.

Conditions

HIV Infections

Keywords

HIV Infections; Anti-HIV Agents; HIV-1

Outcome Measures

Primary Outcomes (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.

  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.

  12 months

Study Arms (2)

ARV-Treated Participants

Those participants who received dapivirine during HIV seroconversion

Drug: No Investigational Product

ARV-Naive Participants

Those participants who received placebo during HIV seroconversion

Drug: No Investigational Product

Interventions

No Investigational Product DRUG

This study is observational in nature and no investigational product will be used. Groups: ARV-Treated Participants, ARV-Naive Participants

ARV-Naive Participants; ARV-Treated Participants

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead

Study Sites (5)

Project Ubuzima

Kiyovu, Kigali, Rwanda

Location

Qhakaza Mbokodo

Ladysmith, KwaZulu-Natal, South Africa

Location

Prevention for HIV and AIDS Project (PHIVA)

Pinetown, KwaZulu-Natal, South Africa

Location

Madibeng Centre for Research (MCR)

Brits, 0250, South Africa

Location

Maternal, Adolescent and Child Health (MatCH)

Plessislaer, 3216, South Africa

Location

Related Publications (1)

• Steytler J, van der Ryst E, Craig C, Van Baelen B, Nuttall J, van Niekerk N, Mellors J, Parikh U, Wallis C; IPM 007 Study Team. Clinical Presentation, Treatment Response, and Virology Outcomes of Women Who Seroconverted in the Dapivirine Vaginal Ring Trials-The Ring Study and DREAM. Clin Infect Dis. 2023 Feb 8;76(3):389-397. doi: 10.1093/cid/ciac804.

  PMID: 36189636 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Linda-Gail Bekker

  Desmond Tutu HIV Centre

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: June 13, 2012
• Study Start: October 4, 2012
• Primary Completion: August 6, 2019
• Study Completion: August 6, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

RW (1); ZA (4)