A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States

NCT ID: NCT00799058

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-06
• Study Completion Date: 2011-01-08

Brief Summary

A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women

Detailed Description

This was a double-blind, randomized, placebo-controlled trial, to be conducted over 10 months at five research centers in the USA among 180 healthy, sexually active women, to assess the safety and acceptability of dapivirine Gel 4759, 0.05% 2.5 g, and dapivirine Gel 4789, 0.05% 2.5 g, both vaginal microbicides containing dapivirine, compared to the vaginal HEC-based Universal placebo gel, 2.5 g, containing no active ingredient, used once daily for a period of 12 weeks.

Conditions

HIV-1 Infections

Study Design

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

Study Groups

dapivirine gel 4789

will be applied by participants once daily for 12-weeks treatment period

Group Type: ACTIVE_COMPARATOR

dapivirine 4789

Intervention Type: DRUG

dapivirine gel 4789, 0.05%, 2.5g applied once daily

dapivirine gel 4759

Will be applied by participants once daily for12-weeks treatment period

Group Type: ACTIVE_COMPARATOR

dapivirine gel 4759

Intervention Type: DRUG

dapivirine gel 4759, 0.05%, 2.5g applied once daily

HEC-based placebo gel, 2.5g containing no Dapivirine

Will be applied once daily for 12-weeks treatment period

Group Type: PLACEBO_COMPARATOR

Drug placebo

Intervention Type: DRUG

HEC-based universal placebo gel, 2.5g applied once daily

Interventions

dapivirine 4789

dapivirine gel 4789, 0.05%, 2.5g applied once daily

Intervention Type: DRUG

dapivirine gel 4759

dapivirine gel 4759, 0.05%, 2.5g applied once daily

Intervention Type: DRUG

Drug placebo

HEC-based universal placebo gel, 2.5g applied once daily

Intervention Type: DRUG

Other Intervention Names

TMC120; TMC120; HEC-based placebo gel, 2.5g

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 trial

3. Healthy and self-reported sexually active

4. HIV-negative as determined by an HIV test at time of enrollment

5. Willing to be on a stable form of contraception

6. In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle

7. Upon pelvic/speculum examination and colposcopy at the enrollment visit, the cervix and vagina appear normal as determined by qualified research center staff

8. Asymptomatic for genital infections at the time of enrollment

9. Willing to refrain from use of vaginal products or objects for 14 days prior to enrollment and for the duration of the trial.

10. Documentation of no abnormality on Pap smear within 90 days prior to randomization;

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

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

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

14. Willing to abstain from all the following criteria beginning 48 hours prior to each trial visit:

• Vaginal intercourse
• Oral contact with her genitalia
• Internal vaginal washing
• Penetration of the vagina by fingers, sex toys, or any other objects, including medications

15. Willing to abstain from all of the following for 3 days after biopsy procedures:

• Vaginal intercourse
• Oral contact with her genitalia
• Internal vaginal washing
• Penetration of the vagina by fingers, sex toys, or any other objects, including medications

Exclusion Criteria

1. Currently pregnant or having had their last pregnancy outcome within 3 months prior to screening

2. Currently breast-feeding, or having breastfed within 3 months prior to screening

3. Receipt of any investigational agent within 60 days prior to screening

4. Previously participated in any HIV vaccine trial

5. Untreated urogenital infections within 2 weeks prior to enrollment

6. Presence of any 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, or urethral obstruction

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

9. History of symptomatic or asymptomatic HSV-2

10. Any Grade 2, 3 or 4 hematology, chemistry or urinalysis laboratory abnormality at baseline

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

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

13. Any serious acute, chronic or progressive disease

14. Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial 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

Responsibility Role: SPONSOR

Principal Investigators

Dr Annalene Nel

Role: STUDY_CHAIR

International Partnership for Microbicides

Locations

University of Alabama at Birmingham, Alabama Microbicide Clinical Research Site (AMCRS)

Birmingham, Alabama, United States

Harbor-UCLA Medical Center

Torrance, California, United States

University of Illinois at Chicago

Chicago, Illinois, United States

SNBL Clinical Pharmacology Center

Baltimore, Maryland, United States

Albert Einstein College of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

IPM 020

Identifier Type: -

Identifier Source: org_study_id