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Microbicide Gel Distribution for HIV Prevention

Phase 1
Waitlist Available
Led By Kurt Barnhart, MD
Research Sponsored by Biosyn
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-45 year old women
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will assess how well a microbicide gel is distributed in the vagina and whether it leaves any 'bare spots.' MRIs with and without a contrast agent will be used to determine if the bare spots are just an MRI technique artifact.

Who is the study for?
This trial is for women aged 18-45 who are not pregnant, have a normal Pap smear result, and do not suffer from claustrophobia. Women with allergies to the gel's ingredients, those who are pregnant or breastfeeding, or have abnormal pelvic exams cannot participate.Check my eligibility
What is being tested?
The study is testing how well a microbicidal gel spreads inside the vagina using MRI scans. Some MRIs will include Gadolinium contrast with the gel to see if it changes what they can see about the gel's coverage.See study design
What are the potential side effects?
Potential side effects may include discomfort from the MRI procedure or reactions to Gadolinium if used. The topical gel might cause local irritation or an allergic reaction in some individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged between 18 and 45.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Presence or absence of bare spots with and without Gd.
Quantification and location of bare spots.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BiosynLead Sponsor
7 Previous Clinical Trials
5,417 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,263 Previous Clinical Trials
5,483,231 Total Patients Enrolled
Kurt Barnhart, MDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
462 Total Patients Enrolled

Media Library

Microbicidal Gel (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00214812 — Phase 1
Human Immunodeficiency Virus Infection Research Study Groups:
Human Immunodeficiency Virus Infection Clinical Trial 2023: Microbicidal Gel Highlights & Side Effects. Trial Name: NCT00214812 — Phase 1
Microbicidal Gel (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00214812 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment open to those below the age of fifty?

"According to the eligibility guidelines, this medical trial is available for those aged 18 through 45. In contrast, there are 108 studies specifically aimed at minors and 353 trials targeting people over 65 years old."

Answered by AI

Is it possible to partake in this investigation?

"This medical study is recruiting 6 individuals with HIV infections between 18 and 45 years old who must meet the following qualifications: female, aged 18 to 45, and not expecting a child."

Answered by AI

Are there vacancies for patient participation in this clinical investigation?

"This clinical investigation is no longer recruiting individuals, as per the data found on clincialtrials.gov - it was first published in June 2005 and its most recent update came from October of that year. Nevertheless, there are presently 485 other studies actively seeking participants for their trials at this present moment."

Answered by AI

Has this particular therapy been endorsed by the Federal Drug Administration?

"Due to the limited evidence concerning its efficacy and safety, this treatment was given a score of 1 on our team's risk assessment scale."

Answered by AI
~0 spots leftby Mar 2025