An Expanded Safety Study of Dapivirine Gel 4759 in Africa

NCT00917891 | Completed Phase 1 DMC

• 1 other identifier: IPM 014A
• Study Type: interventional
• Target: 280
• Locations: 5 countries
• Sites: 10

Brief Summary

The purpose of this study is to determine whether dapivirine gel 4759 is safe for daily use by healthy women in Kenya, Malawi, Rwanda, South Africa and Tanzania.

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Keywords

HIV Infections; Acquired Immunodeficiency Syndrome; Healthy; HIV seronegativity

Outcome Measures

Primary Outcomes (3)

• Gynaecological examinations, including pelvic/speculum examination and colposcopy, and laboratory STI testing.

  Week 0, 1, 2, 4, 6 & 10

• Safety laboratory tests

  enrollment & last day of gel use

• Adverse event/serious adverse event reports

  throughout study

Secondary Outcomes (2)

• Questionnaires concerning acceptability and adherence to daily use of vaginal gel.

  Week 0, 2, 6 & 10

• Documentation of adherence to the DMA method including the Applicator Collection Checklist, focus groups and male interviews.

  throughout study

Study Arms (2)

vehicle placebo gel

PLACEBO COMPARATOR

Drug: placebo

dapivirine gel

EXPERIMENTAL

Drug: dapivirine

Interventions

dapivirine DRUG

dosage form: vaginal gel dosage: 1.25mg dapivirine/day frequency: once daily duration: 6 weeks

dapivirine gel

placebo DRUG

dosage form: vaginal gel frequency: once daily duration: 6 weeks

vehicle placebo gel

Eligibility Criteria

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

You may qualify if:

• Women 18 to 40 years of age inclusive who can give written informed consent
• Available for all visits and consent to follow all procedures scheduled for the study
• Agree to daily application of gel and monitoring as per Daily Monitored Adherence (DMA) method
• Healthy and self-reported sexually active
• HIV-negative as determined by a HIV rapid test at time of enrollment
• On a stable form of contraception and willing to continue on this stable method of contraception, OR, Have undergone surgical sterilisation 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 36 days between menses
• Upon pelvic/speculum examination and colposcopy at the time of enrollment, the cervix and vagina appear normal as determined by the investigator
• Asymptomatic for genital infections at the time of enrollment
• Willing to refrain from use of vaginal products or objects within 14 days prior to enrollment and for the duration of the study
• Willing to answer acceptability and adherence questionnaires throughout the study
• Willing to refrain from participation in any other research study for the duration of this study
• 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 outcome 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 (either symptomatic or asymptomatic) within 2 weeks prior to enrollment
• Presence of 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, urethral obstruction
• Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation
• Any Grade 2, 3 or 4 baseline haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Experiences
• Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrollment
• Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex
• 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

Kisumu, Kenya

Location

Johns Hopkins Project, College of Medicine

Blantyre, Malawi

Location

Projet Ubuzima

Kigali, Rwanda

Location

Be Part Clinic, Mbekweni

Paarl, Eastern Cape, South Africa

Location

Qhakaza Mbokodo

Ladysmith, KwaZulu-Natal, South Africa

Location

Prevention for HIV and AIDS Project

Pinetown, KwaZulu-Natal, South Africa

Location

Ndlela HIV Research and Clinical Tirals Unit

Agincourt, Mpumalanga, South Africa

Location

Madibeng Centre for Research

Brits, North West, South Africa

Location

Desmond Tutu HIV Foundation, Nyanga

Cape Town, Western Cape, South Africa

Location

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

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; Slow Virus 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, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 10, 2009
• Study Start: November 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 12, 2011

Record last verified: 2011-09

Locations

MA (1); RW (1); KE (1); ZA (6); TA (1)