A Safety Study of Dapivirine Vaginal Ring in Africa

NCT01071174 | Completed Phase 1 DMC

• 1 other identifier: IPM 015
• Study Type: interventional
• Target: 280
• Locations: 4 countries
• Sites: 10

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

Keywords

HIV infections; Anti-HIV agents; HIV-1

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Acceptability of the product determined by questionnaire.

  16 weeks

• Adherence to the protocol-specific product regimen as determined by self-report and clinician observation at each study visit.

  12 weeks

Study Arms (2)

Placebo Ring

PLACEBO COMPARATOR

Vaginal Ring containing no drug substance

Other: Placebo

Dapivirine Ring

EXPERIMENTAL

Dapivirine Vaginal Ring 25mg

Other: Dapivirine

Interventions

Dapivirine OTHER

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

Dapivirine Ring

Placebo OTHER

Vaginal Ring containing no drug substance

Placebo Ring

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead

Study Sites (10)

Kenya Medical Research Institute (KEMRI)

Kisumu, Kenya

Location

University of North Carolina Project

Lilongwe, Malawi

Location

Reproductive Health and HIV Research Unit (RHRU)

Edendale, KwaZulu-Natal, South Africa

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

Brits, North West, South Africa

Location

Desmond Tutu HIV Foundation Masiphumelele

Cape Town, Western Cape, South Africa

Location

Desmond Tutu HIV Foundation Nyanga

Cape Town, Western Cape, South Africa

Location

Be Part Yoluntu Centre Mbekweni

Paarl, Western Cape, South Africa

Location

Kilimanjaro Christian Medical Centre (KCMC)

Moshi, Tanzania

Location

Related Publications (1)

• 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.

  PMID: 26963505 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Dapivirine

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

• Dr Annalene Nel

  Beijing Immupeutics Medicine Technology Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 19, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 2, 2011

Record last verified: 2011-08

Locations

ZA (7); TA (1); MA (1); KE (1)