A Safety and Efficacy Trial of Dapivirine Vaginal Ring in Africa

HIV Infections Clinical Trial

Official title:

A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Phase III Safety and Efficacy Trial of a Vaginal Matrix Ring With Dapivirine for the Prevention of HIV-1 Infection in Women

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01337583
• Other study ID #: IPM 009B
• Status: Withdrawn
• Phase: Phase 3
• First received: April 13, 2011
• Last updated: June 8, 2012
• Start date: July 2011
• Est. completion date: July 2014

Study information

• Verified date: June 2012
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control CouncilMalawi: College of Medicine Research and Ethics CommitteeKenya: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This is a double-blind, randomized, placebo-controlled Phase III study to asses the safety and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women >18 and <40 years of age who can provide informed consent

• Available for all visits and consent to follow all procedures scheduled for the trial

• Generally healthy and self-reported sexually active (defined as an average of at least one penetrative penile vaginal coital act per month for the last 3 months prior to enrolment)

• HIV-negative as determined by the HIV algorithm applied at screening and enrolment

• On a stable form of contraception and willing to continue on stable contraception for the duration of the clinical trial;

• Asymptomatic for genital infections at the time of enrolment (if a woman is diagnosed with any clinically significant treatable STI, she must have initiated treatment at least 1 week prior to enrolment and have completed the full course of treatment)

• Willing to answer questions about adherence, sexual behaviour, vaginal practices and ring acceptability;

• Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures (e.g., by home visit or telephone; or via family or close neighbour contacts [confidentiality to be maintained])

• Willing to refrain from participation in another research trial using drugs, vaccines, medical devices, microbicides or oral pre-exposure prophylaxis investigational drugs for the duration of the IPM 009B trial;

• In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle defined as having a minimum of 21 days and a maximum of 35 days between menses;

• Willing to refrain from use of vaginal products or objects including spermicides, tampons, female condoms, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method), douches and drying agents within 14 days from enrolment and for the duration of the trial.

Exclusion Criteria:

• Currently pregnant or last pregnancy within 3 months prior to screening;

• Currently breast-feeding

• Participated in another research trial using drugs, medical devices, microbicides or oral pre-exposure prophylaxis agents within 60 days prior to screening

• Previously participated or currently participating in any HIV vaccine trial

• Untreated, clinically significant urogenital infections (either symptomatic or asymptomatic), e.g., urinary tract or other sexually transmitted infections, or other gynaecological symptoms within 1 week prior to enrolment

• History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction, incontinence or urge incontinence

• Any gynaecological surgery within 90 days prior to enrolment

• Any Grade 3 or 4 baseline haematology, chemistry or urinalysis laboratory value according to the DAIDS Table for Grading Adverse Experiences, or clinically significant Grade 2 findings

• Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or a silicone elastomer

• Any history of diabetes mellitus and chronic use of oral steroid therapy and any uncontrolled serious chronic or progressive disease

• Cervical cytology at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation [this includes any findings of atypical squamous cells of undetermined significance (ASCUS)]

• Any condition(s) that, in the opinion of the investigator, might put the participant at risk, or interfere with the trial objectives, or adherence to trial requirements

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• Infection

Intervention

Other:
• Dapivirine
Vaginal ring containing 25mg dapivirine; one ring inserted every 28 days for at least 15 months
• Placebo
Vaginal Ring containing no drug substance

Drug:
• Dapivirine

Locations

Country	Name	City	State
Kenya	Suba District Hospital	Mbita
Malawi	University of North Carolina Project	Lilongwe
South Africa	Desmond Tutu HIV Foundation, Nyanga (DTHF)	Nyanga	Cape Town
South Africa	Prevention of HIV / AIDS (PHIVA) Project	Pinetown	KwaZulu Natal
South Africa	Maternal, Adolescent and Child Health (MatCH)	Plessislaer

Sponsors (1)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.

Countries where clinical trial is conducted

Kenya,  Malawi,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy as determined by HIV-1 seroconversion rate per person-years of product use, measured at the end of the investigational product use period.	The primary endpoint is HIV-1 seroconversion measured by rapid and specialized laboratory tests according to a comprehensive HIV testing algorithm. This algorithm employs a series of high specificity and high sensitivity immunoassay-based HIV blood tests that minimize the chance of false positive results to determine if a subject is positive for HIV. Endpoint confirmation of HIV infection is by Western blot.	15 months	No
Primary	Safety as determined by grade 3 and 4 AE's, clinically significant grade 2 laboratory findings (based on DAIDS grading) and all serious AE's.	This will be measured by self-reports, physical examination, safety laboratory tests and other specialised investigations.	15 months	Yes
Secondary	Adherence to the protocol-specific product regimen as determined by self-reported diary cards and questionnaires.		15 months	No
Secondary	The incidence of curable STI's or pregnancy as determined by STI testing and pregnancy testing.		15 months	No