NCT04047420

Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Administered Rectally

A Phase 1 Open Label Safety and Pharmacokinetic Study of Rectal Administration of a Tenofovir Alafenamide/Elvitegravir Insert at Two Dose Levels

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of rectal administration of a tenofovir alafenamide (TAF)/elvitegravir (EVG) insert at two dose levels in HIV-uninfected individuals.

Detailed description

This study will evaluate the safety and pharmacokinetics of rectal administration of a tenofovir alafenamide (TAF)/elvitegravir (EVG) insert at two dose levels in HIV-uninfected individuals. All participants will receive a single TAF/EVG Insert at Study Visit 3. After a washout period of at least 7 days, participants will receive two TAF/EVG Inserts at Study Visit 7. The inserts will be administered rectally by study staff. After each dosing visit, samples will be collected over a 3-day period. Participants will attend 10 study visits and will be followed for approximately 6 to 13 weeks. Study visits may include physical and rectal examinations; collection of blood, urine, rectal and vaginal fluid; and interviews. The total duration of the study will be approximately 11 months.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	TAF/EVG Insert	TAF/EVG Insert (20/16 mg) administered rectally by study staff

Timeline

• Start date: 2019-12-11
• Primary completion: 2021-03-03
• Completion: 2021-04-07
• First posted: 2019-08-06
• Last updated: 2023-12-22
• Results posted: 2023-12-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study