New vaginal insert could block HIV and herpes – early trial underway

NCT ID NCT06087913

Completed Prevention Sponsor: Eastern Virginia Medical School Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-stage trial tested a vaginal insert containing two anti-HIV drugs (tenofovir alafenamide and elvitegravir) in 68 healthy women. The insert was used daily for 3 days then every other day for 14 days. The goal was to check safety and measure drug levels in the body, as a first step toward creating an on-demand method to prevent HIV and HSV infection during sex.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: tenofovir alafenamide and elvitegravir vaginal insert
What this could lead to: If successful, this could lead to a new on-demand, event-driven method for preventing HIV and HSV infection during sex.
What could go wrong: This is a very early Phase 1 safety study with only 68 participants. It does not test whether the insert actually prevents infection, and many early-stage products fail to show effectiveness in later trials.

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Conditions

The condition(s) this trial relates to.

herpes simplex infectious disease prevention target HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SAFETY ISSUES

Contacts and locations

Locations

CAPRISA eThekwini Clinical Research Site

Durban, South Africa
Eastern Virginia Medical School Clinical Research Clinic (EVMS CRC)

Norfolk, Virginia, 23507, United States
Kenya Medical Research Institute (KEMRI)

Thika, Kenya

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