An Expanded Safety Study of Dapivirine Gel 4789 in Africa

Healthy Clinical Trial

Official title:

A Double-blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety and Acceptability of Dapivirine Gel 4789, 0.05%, 2.5g, a Vaginal Microbicide, Conducted Using Daily Monitored Adherence in Healthy, HIV-Negative Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917904
• Other study ID #: IPM 014B
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 8, 2009
• Last updated: December 13, 2011
• Start date: July 2009
• Est. completion date: September 2010

Study information

• Verified date: December 2011
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Healthy
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

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

Locations

Country	Name	City	State
South Africa	Madibeng Centre for Research	Brits	North West Province
South Africa	Desmond Tutu HIV Foundation, Masiphumelele	Cape Town	Western Cape
South Africa	Be Part Clinic, Mbekweni	Paarl	Eastern Cape

Sponsors (1)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gynaecological examinations, including pelvic/speculum examination and colposcopy, and laboratory STI testing.		Week 0, 1, 2, 4, 6 & 10	Yes
Primary	Safety laboratory tests		enrollment & last day of gel use	Yes
Primary	Adverse event/serious adverse event reports		throughout study	Yes
Secondary	Questionnaires concerning acceptability and adherence to daily use of vaginal gel.		Week 0, 2, 6 & 10	No
Secondary	Documentation of adherence to the DMA method including the Applicator Collection Checklist, focus groups and male interviews.		throughout study	No

External Links

•   IPM website