NCT00309205

Brief Summary

Approximately 36 HIV-negative women, aged \>18 and \< 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. The volunteers will receive investigational product for a total of 42 days.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2006

Completed
Last Updated

September 1, 2009

Status Verified

August 1, 2009

First QC Date

March 30, 2006

Last Update Submit

August 31, 2009

Conditions

HIV InfectionsHIV-1

Keywords

HIV seronegativity

Outcome Measures

Primary Outcomes (1)

  • Local and systemic safety and tolerability.

Interventions

dapivirine (TMC120) vaginal gelDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • HIV-negative
  • Willing to participate and sign an informed consent form
  • Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
  • Willing to use two forms of contraception during the study
  • Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
  • Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses

You may not qualify if:

  • Currently pregnant or breast-feeding
  • Clinically detectable genital abnormality on the vulva, vaginal walls or cervix
  • Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion
  • Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization
  • Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment.
  • Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SGS Biopharma - Research Unit Stuivenberg

Antwerp, 2060, Belgium

Location

MeSH Terms

Conditions

HIV Infections

Interventions

DapivirineVaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsFeminine Hygiene ProductsEquipment and Supplies

Study Officials

  • Zeda Rosenberg, ScD

    Beijing Immupeutics Medicine Technology Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 30, 2006

First Posted

March 31, 2006

Study Start

December 1, 2005

Last Updated

September 1, 2009

Record last verified: 2009-08

Locations

BE(1)