NCT00214812

Brief Summary

This study will assess the distribution of a microbicidal gel in the vagina and confirm the presence of bare spots. MRIs will be done with and without the addition of the MRI contrast Gadolinium to the microbicide in order to determine whether the bare spots are an artifact of the MRI technique.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

October 25, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

October 24, 2005

Conditions

HIV Infections

Keywords

HIV SeronegativityHIV

Outcome Measures

Primary Outcomes (2)

  • Presence or absence of bare spots with and without Gd.

  • Quantification and location of bare spots.

Interventions

HEC placebo gelDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • year old women
  • normal Pap smear
  • not pregnant

You may not qualify if:

  • abnormal pelvic exam
  • history of claustrophobia
  • allergy to product formulation
  • pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Research Unit, U of Penn Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kurt Barnhart, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kurt Barnhart, MD

CONTACT

215 662 2974

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

June 1, 2005

Last Updated

October 25, 2005

Record last verified: 2005-09

Locations

US(1)