COMPLETED

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

Conditions

Safety Issues rectal insert HIV pre-exposure prophylaxis (PrEP)

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Double-Blind, Placebo-Controlled, Randomized Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Rectally Administered Tenofovir Alafenamide/Elvitegravir Inserts

Quick Facts

Study Start:2024-01-16

Study Completion:2025-05-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06274398

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 59 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Individuals between the ages of 18-59 years 2. Able to understand and give informed consent 3. HIV-negative and willing to be tested for HIV 4. Willing to undergo peripheral blood, urine, rectal secretion collection, and rectal biopsy sampling 5. For those assigned female at birth: Willing to undergo cervicovaginal secretion collection 6. Lifetime history of receptive anal intercourse 7. No contraindication to rectal biopsy (at the investigator's discretion) 8. 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: 1. Hormonal methods 2. Intrauterine device (IUD) inserted at least 30 days prior to enrollment 3. Sterilization (of participant or partner) 4. 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 5. Willing to commit to using condoms for the duration of the study	1. Currently infected with hepatitis virus and/or has liver disease 2. Current or chronic history of kidney disease or CrCl \<60 ml/min 3. 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. 4. Significant laboratory abnormalities at baseline, including but not limited to: 1. Hemoglobin ≤ 10 g/dL 2. Platelet count \<100,000 3. Aspartate aminotransferase (AST) or alanine transaminase (ALT) \>1.3x ULN 4. Serum creatinine \>1.3x upper limit of normal (ULN) 5. PTT \> 1.5x ULN or International normalized ratio (INR) \>1.5x ULN 5. 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: 1. Uncontrolled or severe cardiac arrhythmia 2. Recent major abdominal, cardiothoracic, or neurological surgery in the last 12 months 3. History of uncontrolled bleeding diathesis 6. Current colonic, rectal, or cervicovaginal perforation, fistula, or malignancy 7. Current symptoms or evidence on clinical examination of ulcerative, suppurative, or proliferative lesions of the cervicovaginal and/or anorectal mucosa 8. Current symptoms or evidence on clinical examination of atypical rectal or vaginal discharge 9. Continued need for, or use during the 14 days prior to the rectal biopsy, of the following medications: 1. Aspirin or more than 4 doses of NSAIDs 2. Warfarin, heparin (LMW or unfractionated), platelet aggregation inhibitors, or fibrinolytic agents 3. Any form of rectally administered medications or agents (excluding lubricants or douching) 10. Continued need for, or use during the 90 days prior to enrollment, of the following medications: 1. Systemic immunomodulatory agents 2. Supraphysiologic doses of steroids, except for short course steroids \<7 days duration, at the discretion of the investigator 3. Experimental medications, vaccines, or biologicals (except for COVID-19 vaccines available through the emergency use authorization) 11. Use of moderate or strong CYP inducers/inhibitors (see appendix I) 12. Known or suspected allergy to study product components 13. 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 14. Use of post-exposure prophylaxis (PEP) for potential HIV exposure within 6 months prior to enrollment 15. Pregnant and breastfeeding persons, or intent to become pregnant within the next 6 months 16. Participation in other studies involving the use of drugs, medical devices, rectal and genital products, or vaccines within the past 90 days. 17. 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.

Inclusion Criteria

Exclusion Criteria

1. Individuals between the ages of 18-59 years
2. Able to understand and give informed consent
3. HIV-negative and willing to be tested for HIV
4. Willing to undergo peripheral blood, urine, rectal secretion collection, and rectal biopsy sampling
5. For those assigned female at birth: Willing to undergo cervicovaginal secretion collection
6. Lifetime history of receptive anal intercourse
7. No contraindication to rectal biopsy (at the investigator's discretion)
8. 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:
1. Hormonal methods
2. Intrauterine device (IUD) inserted at least 30 days prior to enrollment
3. Sterilization (of participant or partner)
4. 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
5. Willing to commit to using condoms for the duration of the study

1. Currently infected with hepatitis virus and/or has liver disease
2. Current or chronic history of kidney disease or CrCl \<60 ml/min
3. 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.
4. Significant laboratory abnormalities at baseline, including but not limited to:
1. Hemoglobin ≤ 10 g/dL
2. Platelet count \<100,000
3. Aspartate aminotransferase (AST) or alanine transaminase (ALT) \>1.3x ULN
4. Serum creatinine \>1.3x upper limit of normal (ULN)
5. PTT \> 1.5x ULN or International normalized ratio (INR) \>1.5x ULN
5. 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:
1. Uncontrolled or severe cardiac arrhythmia
2. Recent major abdominal, cardiothoracic, or neurological surgery in the last 12 months
3. History of uncontrolled bleeding diathesis
6. Current colonic, rectal, or cervicovaginal perforation, fistula, or malignancy
7. Current symptoms or evidence on clinical examination of ulcerative, suppurative, or proliferative lesions of the cervicovaginal and/or anorectal mucosa
8. Current symptoms or evidence on clinical examination of atypical rectal or vaginal discharge
9. Continued need for, or use during the 14 days prior to the rectal biopsy, of the following medications:
1. Aspirin or more than 4 doses of NSAIDs
2. Warfarin, heparin (LMW or unfractionated), platelet aggregation inhibitors, or fibrinolytic agents
3. Any form of rectally administered medications or agents (excluding lubricants or douching)
10. Continued need for, or use during the 90 days prior to enrollment, of the following medications:
1. Systemic immunomodulatory agents
2. Supraphysiologic doses of steroids, except for short course steroids \<7 days duration, at the discretion of the investigator
3. Experimental medications, vaccines, or biologicals (except for COVID-19 vaccines available through the emergency use authorization)
11. Use of moderate or strong CYP inducers/inhibitors (see appendix I)
12. Known or suspected allergy to study product components
13. 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
14. Use of post-exposure prophylaxis (PEP) for potential HIV exposure within 6 months prior to enrollment
15. Pregnant and breastfeeding persons, or intent to become pregnant within the next 6 months
16. Participation in other studies involving the use of drugs, medical devices, rectal and genital products, or vaccines within the past 90 days.
17. 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.

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Emory Clinic

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Eastern Virginia Medical School

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-16

Study Completion Date2025-05-16

Study Record Updates

Study Start Date2024-01-16

Study Completion Date2025-05-16

Terms related to this study

Keywords Provided by Researchers

rectal insert
HIV
pre-exposure prophylaxis (PrEP)

Additional Relevant MeSH Terms

Safety Issues