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Integrase Inhibitor

High Eudragit MK-2048 vaginal film for Pharmacokinetics (FAME103 Trial)

Phase 1
Waitlist Available
Led By Katherine Bunge, MD
Research Sponsored by Hillier, Sharon, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 28 days
Awards & highlights

FAME103 Trial Summary

This trial is to test whether a vaginal film can deliver a drug for seven days. Two different film formulations will be compared for safety and how well the drug is absorbed.

Eligible Conditions
  • Pharmacokinetics
  • Safety

FAME103 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Grade 2 or Higher Adverse Events
Secondary outcome measures
Area Under the Cervical Tissue Homogenate Concentration Versus Time Curve of MK-2048
Area Under the Cervicovaginal Lavage Fluid Concentration Versus Time Curve of MK-2048
Area Under the Plasma Concentration Versus Time Curve of MK-2048
+2 more
Other outcome measures
HIV Antibodies
Mean Change in Nugent Score
Median Fold Change in Percent Inhibition of Human Immunodeficiency Virus-1 Replication in Cervicovaginal Lavage Fluid

FAME103 Trial Design

2Treatment groups
Active Control
Group I: High Eudragit MK-2048 vaginal filmActive Control1 Intervention
Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®).
Group II: Low Eudragit MK-2048 vaginal filmActive Control1 Intervention
Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®).

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Hillier, Sharon, PhDLead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,200 Total Patients Enrolled
2 Trials studying Pharmacokinetics
56 Patients Enrolled for Pharmacokinetics
Sharon L Hillier, PhDStudy ChairUniversity of Pittsburgh
10 Previous Clinical Trials
2,196 Total Patients Enrolled
1 Trials studying Pharmacokinetics
50 Patients Enrolled for Pharmacokinetics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048
Katherine Bunge 2020. "Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04319718.
~8 spots leftby Apr 2025
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