Safety IssuesPhase 1RITE PrEPNCT06274398
Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study
A Phase 1 study testing TAF/EVG rectal insert in people with Safety Issues, run by Eastern Virginia Medical School at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- TAF/EVG rectal insert
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2024to 16 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
- Known or suspected allergy to study product components
- Use of pre-exposure prophylaxis (PrEP) for HIV prevention within 3 months prior to enrollment, and/or anticipated use and/or unwillingness to abstain from PrEP during trial participation
- Use of post-exposure prophylaxis (PEP) for potential HIV exposure within 6 months prior to enrollment
- Pregnant and breastfeeding persons, or intent to become pregnant within the next 6 months
- Participation in other studies involving the use of drugs, medical devices, rectal and genital products, or vaccines within the past 90 days.
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Rectally Administered Tenofovir Alafenamide/Elvitegravir Inserts
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.
Read the detailed description
The purpose of this study is to collect data regarding the safety and pharmacokinetics of repeat dosing schedules of TAF and EVG administered rectally to inform the development of future studies to assess the efficacy of this drug combination and mode of administration for use as on-demand PrEP in individuals at risk of acquiring HIV-1 infection.
Eligible participants will be stratified according to sex assigned at birth and then randomized 1:1 to either receive TAF/EVG inserts or placebo for self-administration during the study phases. During Phase 1, participants will self-administer two TAF/EVG or placebo rectal inserts for 3 consecutive days and return to the clinic at 24, 48, and 72 hours after the last dose for biological sample collection. During Phase 2, participants will administer two TAF/EVG or placebo rectal inserts every other day for 7 doses and return to the clinic at 24 hours, 48 hours, 72 hours and 7 days after the final dose for biological sample collection. There will be a washout period of 7 to 28 days between the study phases.
- Conditions
- Safety Issues
- Being tested
- TAF/EVG rectal insert, Matching placebo rectal insert
- Keywords
- rectal insert, HIV, pre-exposure prophylaxis (PrEP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAF/EVG rectal insertDrug
Phase 1: rectal inserts applied daily for 3 consecutive days Phase 2: rectal inserts applied every other day for 14 days
Matching placebo rectal insertDrug
Phase 1: rectal inserts applied daily for 3 consecutive days Phase 2: rectal inserts applied every other day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | 2 TAF/EVG (20/16mg) rectal inserts Receives: Drug: TAF/EVG rectal insert |
| Placebo | Placebo comparator | 2 Matching placebo inserts Receives: Drug: Matching placebo rectal insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and intensity of Adverse Events
Safety measured by Grade 2 and higher adverse events (AEs)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
concentrations of TFV and EVG
Measured: 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
concentrations TFV-DP and EVG
Measured: at 24 hours after last rectal dose administration of study product in each Dosing Phase.
Cytokine Profiles
To assess a change in cytokine profiles in rectal and vaginal secretions
Measured: 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
To assess a change to the microbiome composition in rectum and vagina
Measured: at baseline and at 24, 48, and 72 hours after last rectal dose administration of study product in Dosing Phases 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start16 Jan 2024
- Primary completion31 Mar 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Placebo-controlled, Double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- CONRAD, Emory University, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Cassie Grimsley Ackerley, MD, MSc, Principal investigator, Emory School of MedicineRichard E Haaland, Study chair, Centers for Disease Control and PreventionGustavo F Doncel, MD, PhD, Study chair, CONRAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274398
- Sponsor's protocol ID
- RITE Study
- Acronym
- RITE PrEP
- Status last verified
- Feb 2025
- First submitted
- 31 Jan 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Rectally Administered Tenofovir Alafenamide/Elvitegravir Inserts
- ClinicalTrials.gov ID
- NCT06274398
- Acronym / sponsor ID
- RITE PrEP / RITE Study
- Conditions
- Safety Issues
- Keywords
- rectal insert, HIV, pre-exposure prophylaxis (PrEP)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- CONRAD, Emory University, Centers for Disease Control and Prevention
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to collect data regarding the safety and pharmacokinetics of repeat dosing schedules of TAF and EVG administered rectally to inform the development of future studies to assess the efficacy of this drug combination and mode of administration for use as on-demand PrEP in individuals at risk of acquiring HIV-1 infection.
Eligible participants will be stratified according to sex assigned at birth and then randomized 1:1 to either receive TAF/EVG inserts or placebo for self-administration during the study phases. During Phase 1, participants will self-administer two TAF/EVG or placebo rectal inserts for 3 consecutive days and return to the clinic at 24, 48, and 72 hours after the last dose for biological sample collection. During Phase 2, participants will administer two TAF/EVG or placebo rectal inserts every other day for 7 doses and return to the clinic at 24 hours, 48 hours, 72 hours and 7 days after the final dose for biological sample collection. There will be a washout period of 7 to 28 days between the study phases.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Placebo-controlled, Double-blind
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: TAF/EVG rectal insert2 TAF/EVG (20/16mg) rectal inserts |
| Placebo | Placebo comparator | Drug: Matching placebo rectal insert2 Matching placebo inserts |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (31 listed)
- 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:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAF/EVG rectal insertPhase 1: rectal inserts applied daily for 3 consecutive days Phase 2: rectal inserts applied every other day for 14 days | Drug | Active |
| Matching placebo rectal insertPhase 1: rectal inserts applied daily for 3 consecutive days Phase 2: rectal inserts applied every other day for 14 days | Drug | Placebo |
Primary outcome
Frequency and intensity of Adverse Events
Time frame: from enrollment until Day 57 (after last rectal dose administration of study product)
Safety measured by Grade 2 and higher adverse events (AEs)
Pharmacokinetics (PK) (maximum concentration (Cmax)) in blood
Time frame: baseline and at 24, 48, and 72 hours after last rectal dose administration of study product in each Dosing Phase.
concentrations of TFV-DP and EVG
PK (Cmax) in rectal secretions
Time frame: baseline and at 24, 48, and 72 hours after last rectal dose administration of study product in each Dosing Phase.
concentrations of TFV-DP and EVG
PK (Cmax) in rectal mucosal tissue
Time frame: at 24 and 72 hours after last rectal dose administration of study product in each Dosing Phase.
concentrations of TFV-DP and EVG
4 secondary outcomes
PK (Cmax) in cervicovaginal secretions
Time frame: 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
Time frame: at 24 hours after last rectal dose administration of study product in each Dosing Phase.
Cytokine Profiles
Time frame: 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
Time frame: at baseline and at 24, 48, and 72 hours after last rectal dose administration of study product in Dosing Phases 1 and 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cassie Grimsley Ackerley, MD, MSc principal investigator
Emory School of Medicine
Richard E Haaland study chair
Centers for Disease Control and Prevention
Gustavo F Doncel, MD, PhD study chair
CONRAD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAF/EVG rectal insert in people with Safety Issues, run by Eastern Virginia Medical School at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and intensity of Adverse Events (time frame: from enrollment until Day 57 (after last rectal dose administration of study product)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.