Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study

NCT06274398 | Completed Phase 1 FDA Drug

• 1 other identifier: RITE Study
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days.

Conditions

Safety Issues

Keywords

rectal insert; HIV; pre-exposure prophylaxis (PrEP)

Outcome Measures

Primary Outcomes (4)

• Frequency and intensity of Adverse Events

  Safety measured by Grade 2 and higher adverse events (AEs)

  from enrollment until Day 57 (after last rectal dose administration of study product)

• Pharmacokinetics (PK) (maximum concentration (Cmax)) in blood

  concentrations of TFV-DP and EVG

  baseline and at 24, 48, and 72 hours after last rectal dose administration of study product in each Dosing Phase.

• PK (Cmax) in rectal secretions

  concentrations of TFV-DP and EVG

  baseline and at 24, 48, and 72 hours after last rectal dose administration of study product in each Dosing Phase.

• PK (Cmax) in rectal mucosal tissue

  concentrations of TFV-DP and EVG

  at 24 and 72 hours after last rectal dose administration of study product in each Dosing Phase.

Secondary Outcomes (4)

• PK (Cmax) in cervicovaginal secretions

  at baseline and at 24, 48, and 72 hours after last rectal dose administration of study product in each Dosing Phase.

• PK (Cmax) in cerviocovaginal mucosal tissues

  at 24 hours after last rectal dose administration of study product in each Dosing Phase.

• Cytokine Profiles

  at baseline and at 24, 48, and 72 hours after last rectal dose administration of study product in Dosing Phases 1 and 2

• Microbiome Profiles

  at baseline and at 24, 48, and 72 hours after last rectal dose administration of study product in Dosing Phases 1 and 2

Study Arms (2)

Active

EXPERIMENTAL

2 TAF/EVG (20/16mg) rectal inserts

Drug: TAF/EVG rectal insert

Placebo

PLACEBO COMPARATOR

2 Matching placebo inserts

Drug: Matching placebo rectal insert

Interventions

TAF/EVG rectal insert DRUG

Phase 1: rectal inserts applied daily for 3 consecutive days Phase 2: rectal inserts applied every other day for 14 days

Active

Matching placebo rectal insert DRUG

Phase 1: rectal inserts applied daily for 3 consecutive days Phase 2: rectal inserts applied every other day for 14 days

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals between the ages of 18-59 years
• Able to understand and give informed consent
• HIV-negative and willing to be tested for HIV
• Willing to undergo peripheral blood, urine, rectal secretion collection, and rectal biopsy sampling
• For those assigned female at birth: Willing to undergo cervicovaginal secretion collection
• Lifetime history of receptive anal intercourse
• No contraindication to rectal biopsy (at the investigator's discretion)
• For participants of childbearing potential: Willing to use an effective method of contraception for at least 30 days prior to enrollment and for the duration of study participation. Effective methods include:
• Hormonal methods
• Intrauterine device (IUD) inserted at least 30 days prior to enrollment
• Sterilization (of participant or partner)
• Sexually abstinent as defined by abstaining from penile-vaginal intercourse for 90 days prior to enrollment and intending to remain abstinent for the duration of study participation
• Willing to commit to using condoms for the duration of the study

You may not qualify if:

• Currently infected with hepatitis virus and/or has liver disease
• Current or chronic history of kidney disease or CrCl \<60 ml/min
• History of inflammatory bowel disease or other inflammatory, infiltrative, infectious, or vascular condition of the lower GI tract which at the judgement of the investigator, may be worsened by study procedures or may significantly distort the anatomy of the distal large bowel.
• Significant laboratory abnormalities at baseline, including but not limited to:
• Hemoglobin ≤ 10 g/dL
• Platelet count \<100,000
• Aspartate aminotransferase (AST) or alanine transaminase (ALT) \>1.3x ULN
• Serum creatinine \>1.3x upper limit of normal (ULN)
• PTT \> 1.5x ULN or International normalized ratio (INR) \>1.5x ULN
• Any known medical condition that, in the judgement of the investigators, increases the risk of local or systemic complications of biopsy procedures or pelvic examination, including but not limited to:
• Uncontrolled or severe cardiac arrhythmia
• Recent major abdominal, cardiothoracic, or neurological surgery in the last 12 months
• History of uncontrolled bleeding diathesis
• Current colonic, rectal, or cervicovaginal perforation, fistula, or malignancy
• Current symptoms or evidence on clinical examination of ulcerative, suppurative, or proliferative lesions of the cervicovaginal and/or anorectal mucosa

Sponsors & Collaborators

• Eastern Virginia Medical School: lead
• CONRAD: collaborator
• Emory University: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Study Officials

• Cassie Grimsley Ackerley, MD, MSc

  Emory School of Medicine

  PRINCIPAL INVESTIGATOR

• Richard E Haaland

  Centers for Disease Control and Prevention

  STUDY CHAIR

• Gustavo F Doncel, MD, PhD

  CONRAD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Placebo-controlled, Double-blind

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 23, 2024
• Study Start: January 16, 2024
• Primary Completion: March 31, 2025
• Study Completion: May 16, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)