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Antiretroviral Agent

TAF/EVG Vaginal Insert for HIV Prevention

Phase 1

Recruiting

Research Sponsored by Eastern Virginia Medical School

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Assigned female sex at birth

Aged 18 to 50 years (inclusive) at Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of study, an average of 3 months

Awards & highlights

Study Summary

This trial will study a new vaginal insert to prevent HIV/HSV infection. Used daily for 3 days, then every other day for 14 days.

Who is the study for?

This trial is for healthy women aged 18-50 who are not pregnant, do not plan to become pregnant or breastfeed during the study, and use effective contraception. They must have a normal cervicovaginal exam, no history of significant allergies to study products, no recent treatments for certain STIs or use of investigational drugs/devices. Participants should be HIV-negative with an intact uterus and cervix.Check my eligibility

What is being tested?

The MATRIX-001 study tests the safety and pharmacokinetics (how the drug moves through the body) of TAF/EVG vaginal inserts compared to placebo inserts. The goal is to see if these can prevent HIV/HSV infection when used before sexual activity. Women will use them daily for three days then every other day for two weeks.See study design

What are the potential side effects?

Potential side effects may include local irritation or discomfort in the vaginal area due to insert usage. Since this is a safety trial, part of its purpose is to identify any additional side effects from using TAF/EVG vaginal inserts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was assigned female at birth.

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I am between 18 and 50 years old.

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I am over 21 and have had a normal Pap smear in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of study, an average of 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of study, an average of 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of study, an average of 3 months 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 and Severity of Adverse Events

Secondary outcome measures

Modeled in vitro Pharmacodynamics (PD) for HIV

Modeled in vitro Pharmacodynamics (PD) for Herpes simplex virus (HSV)

Number of participants who find using the vaginal insert acceptable.

+4 more

Other outcome measures

Modeled Tissue PD

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention

TAF/EVG (20/16mg) vaginal insert

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo insert

0 / 3Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

CONRADOTHER

58 Previous Clinical Trials

11,553 Total Patients Enrolled

University of PittsburghOTHER

1,723 Previous Clinical Trials

16,343,096 Total Patients Enrolled

Eastern Virginia Medical SchoolLead Sponsor

69 Previous Clinical Trials

14,391 Total Patients Enrolled

Frequently Asked Questions

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

Is the age limit of 35 years for this clinical trial rigidly enforced?

"Aspiring participants must be aged 18 or greater, yet younger than 50 to qualify for this clinical trial."

Answered by AI

Has the FDA sanctioned Active as a viable medical treatment?

"Given the paucity of data available from Phase 1 trials, our team at Power has assigned Active a safety rating of 1."

Answered by AI

May I enroll in this research endeavor?

"To take part in this clinical trial, individuals must have safety concerns and fall between the ages of 18 and 50. At present, a total of 60 participants are being recruited."

Answered by AI

Is this experiment currently enrolling participants?

"As indicated on clinicaltrials.gov, the recruitment process for this medical trial has concluded; it was published in October of 2023 and last updated shortly thereafter. However, there are currently 34 other trials that require participants to join their study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert

2023. "Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06087913.