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CROSSOVER STUDY OF ON-DEMAND PREP FORMULATIONS COMPARING RECTAL AND ORAL TENOFOVIR | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

CROSSOVER STUDY OF ON-DEMAND PREP FORMULATIONS COMPARING RECTAL AND ORAL TENOFOVIR

A PHASE 2 CROSSOVER STUDY OF ON-DEMAND PREP FORMULATIONS COMPARING RECTAL AND ORAL TENOFOVIR-BASED PREP EVALUATING EXTENDED SAFETY, ACCEPTABILITY, AND PHARMACOKINETICS/PHARMACODYNAMICS

NCT06560684•National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

This is a Phase 2, multi-site, two-period, open label randomized crossover (Period 1 and 2) study. Participants are randomized 1:1 to one of two 8-week on-demand product sequences - TFV douche then oral F/TDF or oral F/TDF then TFV douche - with a 2 to 4-week washout period in between. Domains of safety, acceptability, adherence, and PK/PD (sub-study only) are assessed for each product.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Men aged 18 years or older at the time of screening informed consent
•2. Willing and able to provide informed consent to take part in the study
•3. Able to read at a level required for the study components (e.g., CASI and SMS)
•4. Have access to device and the internet for completion of study procedures
•5. Understand and agree to local STI reporting requirements
•6. Non-reactive/negative HIV test results at screening and enrollment
•7. A history of consensual RAI at least five times in their lifetime and at least once in the prior 3 months
•8. Received or self-administered an enema or rectal douche more than half the time prior to engaging in RAI in the past year.
•9. Willing and able to use condoms for all sexual intercourse for the duration of participation
•10. Agrees not to participate in other research studies involving drugs, biologics, medical devices, vaccines, anal products, or genital products for the duration of the study
+7 more criteria

Exclusion Criteria

•1. Any reactive/positive HIV test at screening or at least one reactive/positive test result at enrollment, even if HIV infection is not confirmed
•2. History of active (including chronic) hepatitis B virus (HBV) infection, as documented by positive HBV surface antigen (HBsAg) at screening
•3. Co-enrollment in any other interventional research study that may interfere with this study (as provided by self-report or other available documentation). Exceptions may be made after consultation with the Clinical Management Committee (CMC).
•4. ≥ Grade 2 clinically significant laboratory abnormality at baseline as defined by The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 dated July 2017, except for estimated glomerular filtration rate (eGFR), which must be \>75 mL/min/1.73m\^2. (Coagulation (PT/INR) results ≥ Grade 2 are not exclusionary for the main study).
•5. Significant colorectal symptom(s) as determined by medical history or by participant self-report (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, history of inflammatory bowel disease, presence of symptomatic external hemorrhoids, and presence of any painful anorectal conditions that would be tender to manipulation)
•6. At screening, participant-reported symptoms and/or clinical or laboratory diagnosis of active rectal or reproductive tract infection requiring treatment per current CDC guidelines or symptomatic urinary tract infection (UTI)
•a.Infections requiring treatment include chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, genital sores or ulcers, and, if clinically indicated, genital warts.
•Note: if an STI apart from HIV is detected, the participant will be referred for treatment and, upon documented confirmation of definitive treatment, can be retested in three weeks for evidence of adequate treatment.
•7. History of an underlying clinically significant cardiac arrhythmia or renal disease
•8. History of severe or recent cardiac or pulmonary event
+13 more criteria

Locations (8)

Alabama CRS (Site ID# 31788)

Birmingham, Alabama, United States

UCLA CARE Center CRS

Los Angeles, California, United States

Hope Clinic CRS

Lawrenceville, Georgia, United States

Johns Hopkins University CRS

Baltimore, Maryland, United States

Fenway Health (FH) CRS

Boston, Massachusetts, United States

Weill Cornell Chelsea CRS

New York, New York, United States

Chapel Hill CRS (3201)

Chapel Hill, North Carolina, United States

University of Pittsburgh CRS

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

October 29, 2024

Primary Completion Date

May 15, 2026

Completion Date

May 15, 2026

Last Updated

January 16, 2026

Enrollment

150

ESTIMATED participants

Conditions

Tenofovir

Interventions

Oral F/TDF Pills

DRUG

TFV rectal douche

DRUG

Effect of Long-Term Use of Tenofovir (TDF) on Bone Density in Patients With Chronic Hepatitis B

NCT06990438

Tenofovir Disoproxil FumarateBone Density+1 more

View study

COMPLETEDPHASE1

Coital Pharmacokinetics/Pharmacodynamics (PK/PD) of Tenofovir Gel

NCT01687205

Pharmacokinetics of 1% Tenofovir Gel Following CoitusPharmacodynamics of 1% Tenofovir Gel Following Coitus

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CROSSOVER STUDY OF ON-DEMAND PREP FORMULATIONS COMPARING RECTAL AND ORAL TENOFOVIR

Inclusion Criteria

Exclusion Criteria

Effect of Long-Term Use of Tenofovir (TDF) on Bone Density in Patients With Chronic Hepatitis B

Coital Pharmacokinetics/Pharmacodynamics (PK/PD) of Tenofovir Gel

Tenofovir-DF Versus Hydroxychloroquine in the Treatment of Hospitalized Patients With COVID-19 (TEDHICOV)