An Expanded Safety Study of Dapivirine Gel 4789 in Africa

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
HIV Infections; Acquired Immunodeficiency Syndrome; Healthy	Drug: dapivirine; Drug: placebo	Phase 1; Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
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.
Study Start Date :	July 2009
Actual Primary Completion Date :	September 2010
Actual Study Completion Date :	September 2010

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: vehicle placebo gel	Drug: placebo; dosage form: vaginal gel frequency: once daily duration: 6 weeks
Experimental: dapivirine gel	Drug: dapivirine; dosage form: vaginal gel dosage: 1.25mg dapivirine/day frequency: once daily duration: 6 weeks

Outcome Measures

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Primary Outcome Measures :

1. Gynaecological examinations, including pelvic/speculum examination and colposcopy, and laboratory STI testing. [ Time Frame: Week 0, 1, 2, 4, 6 & 10 ]
2. Safety laboratory tests [ Time Frame: enrollment & last day of gel use ]
3. Adverse event/serious adverse event reports [ Time Frame: throughout study ]

Secondary Outcome Measures :

1. Questionnaires concerning acceptability and adherence to daily use of vaginal gel. [ Time Frame: Week 0, 2, 6 & 10 ]
2. Documentation of adherence to the DMA method including the Applicator Collection Checklist, focus groups and male interviews. [ Time Frame: throughout study ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Locations

South Africa
Be Part Clinic, Mbekweni
Paarl, Eastern Cape, South Africa
Madibeng Centre for Research
Brits, North West Province, South Africa
Desmond Tutu HIV Foundation, Masiphumelele
Cape Town, Western Cape, South Africa, 7975

Sponsors and Collaborators

International Partnership for Microbicides, Inc.

Investigators

Study Director:	Dr Annalene Nel	IPM

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

IPM website 

Responsible Party:	Annalene Nel, IPM
ClinicalTrials.gov Identifier:	NCT00917904 History of Changes
Other Study ID Numbers:	IPM 014B
First Posted:	June 10, 2009
Last Update Posted:	December 14, 2011
Last Verified:	December 2011

Keywords provided by International Partnership for Microbicides, Inc.:

HIV Infections; Acquired Immunodeficiency Syndrome; Healthy; HIV seronegativity

Additional relevant MeSH terms:

HIV Infections; Immunologic Deficiency Syndromes; Acquired Immunodeficiency Syndrome; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections	Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immune System Diseases; Slow Virus Diseases