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

Completed · Phase 1 · Has a placebo group

Conditions studied: Safety Issues

In brief

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.

Key facts

Study ID

NCT06274398

Run by

Eastern Virginia Medical School

People needed

21

Starts

2024-01-16

Expected to finish

2025-05-16

Last updated by the study team

2025-07-25

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.

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
• Current symptoms or evidence on clinical examination of atypical rectal or vaginal discharge
• Continued need for, or use during the 14 days prior to the rectal biopsy, of the following medications:
• Aspirin or more than 4 doses of NSAIDs
• Warfarin, heparin (LMW or unfractionated), platelet aggregation inhibitors, or fibrinolytic agents
• Any form of rectally administered medications or agents (excluding lubricants or douching)
• Continued need for, or use during the 90 days prior to enrollment, of the following medications:
• Systemic immunomodulatory agents
• Supraphysiologic doses of steroids, except for short course steroids <7 days duration, at the discretion of the investigator
• Experimental medications, vaccines, or biologicals (except for COVID-19 vaccines available through the emergency use authorization)
• Use of moderate or strong CYP inducers/inhibitors (see appendix I)

Where it is running

• Emory Clinic — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.