A Safety Study of Dapivirine Vaginal Ring in Africa

NCT ID: NCT01071174

Last Updated: 2011-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-07-31

Brief 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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo Ring

Vaginal Ring containing no drug substance

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Vaginal Ring containing no drug substance

Dapivirine Ring

Dapivirine Vaginal Ring 25mg

Group Type: EXPERIMENTAL

Dapivirine

Intervention Type: OTHER

Vaginal ring containing 25mg dapivirine; One ring inserted every 28 days for 84 days (3 rings total)

Interventions

Dapivirine

Vaginal ring containing 25mg dapivirine; One ring inserted every 28 days for 84 days (3 rings total)

Intervention Type: OTHER

Placebo

Vaginal Ring containing no drug substance

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

International Partnership for Microbicides, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

International Partnership for Microbicides

Principal Investigators

Dr Annalene Nel

Role: STUDY_DIRECTOR

Beijing Immupeutics Medicine Technology Limited

Locations

Kenya Medical Research Institute (KEMRI)

Kisumu, , Kenya

University of North Carolina Project

Lilongwe, , Malawi

Reproductive Health and HIV Research Unit (RHRU)

Edendale, KwaZulu-Natal, 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

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

Be Part Yoluntu Centre Mbekweni

Paarl, Western Cape, South Africa

Kilimanjaro Christian Medical Centre (KCMC)

Moshi, , Tanzania

Countries

Kenya; Malawi; South Africa; Tanzania

References

Nel A, Bekker LG, Bukusi E, Hellstrӧm E, Kotze P, Louw C, Martinson F, Masenga G, Montgomery E, Ndaba N, van der Straten A, van Niekerk N, Woodsong C. Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa. PLoS One. 2016 Mar 10;11(3):e0147743. doi: 10.1371/journal.pone.0147743. eCollection 2016.

Reference Type: DERIVED

PMID: 26963505 (View on PubMed)

Other Identifiers

IPM 015

Identifier Type: -

Identifier Source: org_study_id