Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study
United States21 participantsStarted 2024-01-16
Plain-language 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.
Who can participate
Age range
18 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Exclusion criteria
. Currently infected with hepatitis virus and/or has liver disease
. Current or chronic history of kidney disease or CrCl \<60 ml/min
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency and intensity of Adverse Events
Timeframe: from enrollment until Day 57 (after last rectal dose administration of study product)
2
Pharmacokinetics (PK) (maximum concentration (Cmax)) in blood
Timeframe: baseline and at 24, 48, and 72 hours after last rectal dose administration of study product in each Dosing Phase.
3
PK (Cmax) in rectal secretions
Timeframe: baseline and at 24, 48, and 72 hours after last rectal dose administration of study product in each Dosing Phase.
4
PK (Cmax) in rectal mucosal tissue
Timeframe: at 24 and 72 hours after last rectal dose administration of study product in each Dosing Phase.
. 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)