An Expanded Safety Study of Dapivirine Gel 4789 in Africa

NCT ID: NCT00917904

Last Updated: 2011-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-09-30

Brief Summary

The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use by healthy women in South Africa.

Detailed Description

To reduce the influence of adherence as a factor in the interpretation of efficacy results, IPM is considering using a DOT (Directly Observed Therapy) based method for vaginal microbicide gel delivery in a future Phase III study. IPM has denoted this DOT based method as Daily Monitored Adherence (DMA). IPM014B is a Phase I/II study designed: (1) to assess and compare the safety of a once daily application of Dapivirine Gel 4789, 0.05% 2.5g and a matching vehicle placebo gel; (2) to assess the acceptability of a once daily application of Dapivirine gel 4789, 0.05% 2.5g and a matching vehicle placebo gel; and (3) to assess the feasibility of utilizing the DMA method for a large-scale phase III efficacy study.

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Healthy

Keywords

HIV Infections; Acquired Immunodeficiency Syndrome; Healthy; HIV seronegativity

Study Design

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

Study Groups

vehicle placebo gel

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

dosage form: vaginal gel

frequency: once daily

duration: 6 weeks

dapivirine gel

Group Type: EXPERIMENTAL

dapivirine

Intervention Type: DRUG

dosage form: vaginal gel

dosage: 1.25mg dapivirine/day

frequency: once daily

duration: 6 weeks

Interventions

dapivirine

dosage form: vaginal gel

dosage: 1.25mg dapivirine/day

frequency: once daily

duration: 6 weeks

Intervention Type: DRUG

placebo

dosage form: vaginal gel

frequency: once daily

duration: 6 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Women 18 to 40 years of age inclusive who can give written informed consent

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

3. Agree to daily application of gel and monitoring as per Daily Monitored Adherence (DMA) method

4. Healthy and self-reported sexually active

5. HIV-negative as determined by a HIV rapid test at time of enrollment

6. 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

7. 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

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

9. Asymptomatic for genital infections at the time of enrollment

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

11. Willing to answer acceptability and adherence questionnaires throughout the study

12. Willing to refrain from participation in any other research study for the duration of this study

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

Exclusion Criteria

1. Currently pregnant or last pregnancy outcome within 3 months prior to enrolment

2. Currently breast-feeding

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

4. Previously participated in any HIV vaccine study

5. Untreated urogenital infections (either symptomatic or asymptomatic) within 2 weeks prior to enrollment

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

7. History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction

8. Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation

9. Any Grade 2, 3 or 4 baseline haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Experiences

10. Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrollment

11. Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex

12. Any serious acute, chronic or progressive disease

13. 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

IPM

Principal Investigators

Dr Annalene Nel

Role: STUDY_DIRECTOR

Beijing Immupeutics Medicine Technology Limited

Locations

Be Part Clinic, Mbekweni

Paarl, Eastern Cape, South Africa

Madibeng Centre for Research

Brits, North West, South Africa

Desmond Tutu HIV Foundation, Masiphumelele

Cape Town, Western Cape, South Africa

Countries

Kenya; Malawi; Rwanda; Tanzania; South Africa

Related Links

http://www.ipmglobal.org/

IPM website

Other Identifiers

IPM 014B

Identifier Type: -

Identifier Source: org_study_id