A Safety Study of Dapivirine Vaginal Ring in Africa

HIV Infections Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety of an Intravaginal Matrix Ring With Dapivirine in Healthy, HIV-Negative Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071174
• Other study ID #: IPM 015
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 17, 2010
• Last updated: August 1, 2011
• Start date: April 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilMalawi: College of Medicine Research and Ethics CommitteeRwanda: Ministry of HealthTanzania: Food & Drug AdministrationKenya: Institutional Review BoardZambia: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety of a silicone elastomer vaginal ring containing 25mg dapivirine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women between 18 and 40 years of age inclusive who can provide informed consent

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

• Healthy and self-reported sexually active

• HIV-negative

• On a stable form of contraception and willing to continue OR have undergone surgical sterilization at least 3 months prior to enrollment

• 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

• Upon pelvic/speculum examination and colposcopy at the time of enrolment, the cervix and vagina appear normal as determined by the investigator

• Asymptomatic for genital infections at the time of enrolment

• Willing to refrain from use of vaginal products or objects within 14 days from enrollment and for the duration of the study

• Willing to answer to acceptability, adherence and behavioural assessments throughout the study

• Willing to refrain from participation in any other research study for the duration of their participation

• Willing to provide adequate locator information for study retention purposes and be reachable per local standard procedures

Exclusion Criteria:

• Currently pregnant or last pregnancy within 3 months prior to enrolment

• Currently breast-feeding

• Participated in any other research study within 60 days prior to screening

• Previously participated in any HIV vaccine study

• Untreated urogenital infections within 2 weeks prior to enrolment

• Presence of any abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy

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

• Pap smear result at screening that requires cryotherapy, biopsy, treatment or further evaluation

• Any Grade 2, 3 or 4 baseline (screening) haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Events

• Any abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrolment

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

• Any serious acute, chronic or progressive disease

• Any condition(s) that, in the opinion of the investigator, might interfere with adherence to study requirements or evaluation of the study objectives

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• Dapivirine
Vaginal ring containing 25mg dapivirine; One ring inserted every 28 days for 84 days (3 rings total)
• Placebo
Vaginal Ring containing no drug substance

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute (KEMRI)	Kisumu
Malawi	University of North Carolina Project	Lilongwe
South Africa	Madibeng Centre for Research	Brits	North West
South Africa	Desmond Tutu HIV Foundation Masiphumelele	Cape Town	Western Cape
South Africa	Desmond Tutu HIV Foundation Nyanga	Cape Town	Western Cape
South Africa	Reproductive Health and HIV Research Unit (RHRU)	Edendale	Kwazulu Natal
South Africa	Qhakaza Mbokodo	Ladysmith	Kwazulu Natal
South Africa	Be Part Yoluntu Centre Mbekweni	Paarl	Western Cape
South Africa	Prevention for HIV and AIDS Project (PHIVA)	Pinetown	Kwazulu Natal
Tanzania	Kilimanjaro Christian Medical Centre (KCMC)	Moshi

Sponsors (1)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.

Countries where clinical trial is conducted

Kenya,  Malawi,  South Africa,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as determined by the proportion of women in each arm experiencing protocol-specified events, including AEs, laboratory abnormalities, cervico-vaginal abnormalities, abnormal vaginal flora/pH during the study.		16 weeks	Yes
Secondary	Acceptability of the product determined by questionnaire.		16 weeks	No
Secondary	Adherence to the protocol-specific product regimen as determined by self-report and clinician observation at each study visit.		12 weeks	No