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Vaginal Gel Distribution Imaging 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 to 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 study how well a topical gel spreads in the human vagina and if it reaches the upper genital tract.

Who is the study for?
This trial is for women aged 18 to 45 with normal Pap test results, regular menstrual cycles, and not pregnant. Participants must be willing to use contraception. It excludes those with abnormal pelvic exams, pregnancy or breastfeeding, hypertension, hemolytic anemia, latex allergy, claustrophobia or other MRI contraindications.Check my eligibility
What is being tested?
The study is testing how well a topical gel spreads inside the human vagina using advanced MRI techniques. Researchers will look at whether any areas are not covered by the gel and if it reaches the upper genital tract.See study design
What are the potential side effects?
Since this trial involves imaging rather than medication or invasive procedures, side effects may include discomfort from lying still during the MRI and potential allergic reactions to any contrast material used.

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
1. Number and size of bare spots, before and after simulated coitus.
2. Number of women with migration of gel into the endocervical canal and/or endometrial canal before and after simulated coitus.

Find a Location

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
3,261 Previous Clinical Trials
5,483,000 Total Patients Enrolled
Kurt Barnhart, MDPrincipal InvestigatorUniversity of Pennsylvania Medical Center
3 Previous Clinical Trials
462 Total Patients Enrolled

Media Library

Topical Gel Application Clinical Trial Eligibility Overview. Trial Name: NCT00260767 — Phase 1
HIV/AIDS Research Study Groups:
HIV/AIDS Clinical Trial 2023: Topical Gel Application Highlights & Side Effects. Trial Name: NCT00260767 — Phase 1
Topical Gel Application 2023 Treatment Timeline for Medical Study. Trial Name: NCT00260767 — Phase 1

Frequently Asked Questions

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

Could I potentially become a participant in this clinical experiment?

"This trial is seeking six patients, aged between 18 and 45 with HIV. To be considered eligible for participation, additional requirements include not being pregnant and the use of effective contraception if applicable to female participants within this age range."

Answered by AI

What level of danger is associated with this therapeutic approach?

"As this is only a Phase 1 trial, our team at Power rated its safety as a 1 on the scale due to lack of evidence in regard to efficacy and safety."

Answered by AI

Are adults aged 30 and over welcome to participate in the trial?

"This medical trial is seeking patients who are of legal age and less than 45 years old."

Answered by AI
~4 spots leftby Mar 2025