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TenofovirPhase 2NCT06560684

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

A Phase 2 study testing Oral F/TDF Pills and TFV rectal douche in people with Tenofovir, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Tenofovir
What is being tested?
Oral F/TDF Pills and TFV rectal douche
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
8 sitesUnited States
Study dates
29 Oct 2024to 16 Jun 2026
Phase
Phase 2
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 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men aged 18 years or older at the time of screening informed consent
  • Willing and able to provide informed consent to take part in the study
  • Able to read at a level required for the study components (e.g., CASI and SMS)
  • Have access to device and the internet for completion of study procedures
  • Understand and agree to local STI reporting requirements
  • Non-reactive/negative HIV test results at screening and enrollment
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  • A history of consensual RAI at least five times in their lifetime and at least once in the prior 3 months
  • Received or self-administered an enema or rectal douche more than half the time prior to engaging in RAI in the past year.
  • Willing and able to use condoms for all sexual intercourse for the duration of participation
  • 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
  • Willing and able to provide adequate locator information
  • Agrees not to knowingly engage in receptive or insertive sexual activity with another study participant for the duration of study participation.
  • Available to return for all study visits and within any site's catchment area
  • ADDITIONAL INCLUSION FOR THOSE IN THE PK/PD SUB-STUDY
  • Willing to refrain from occasional over-the-counter use of aspirin and NSAID use for 72 hours before and after each study biopsy visit
  • Willing to abstain from insertion of anything (e.g., drug/medication, penis, object, sex toy, or enema including take-home enema) into the anorectum for 72 hours before study drug dose and until 72 hours after each flexible sigmoidoscopy with biopsy collection, or one week after the study drug dose, whichever is later
  • Willing and able to use specific condoms and lubricant provided by the study clinic for all RAI for the duration of participation

Who cannot join

  • Any reactive/positive HIV test at screening or at least one reactive/positive test result at enrollment, even if HIV infection is not confirmed
  • History of active (including chronic) hepatitis B virus (HBV) infection, as documented by positive HBV surface antigen (HBsAg) at screening
  • 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).
  • ≥ 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).
  • 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)
  • 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)
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  • 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.
  • History of an underlying clinically significant cardiac arrhythmia or renal disease
  • History of severe or recent cardiac or pulmonary event
  • History of significant gastrointestinal bleeding
  • Use of F/TDF or use of F/TAF as HIV PrEP within 8 weeks prior to screening visit or anticipated use throughout study participation
  • Use of injectable PrEP within 8 weeks prior to the screening visit or anticipated use throughout study participation
  • Use of systemic or anorectal immunomodulatory medications, rectally administered products containing N-9 or corticosteroids, or any investigational products unless otherwise permitted within 4 weeks of screening or planned use at any time during study participation
  • Known allergic reaction to TFV or other components of the test articles
  • Current known partners with HIV, unless with sustained viral suppression on antiretroviral treatment (ART)
  • History of recurrent urticaria
  • Symptoms suggestive of acute HIV infection at screening or enrollment
  • Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease
  • ADDITIONAL EXCLUSION FOR THOSE IN THE PK/PD SUB-STUDY
  • Current medically-indicated use of warfarin or heparin or other anticoagulant medications associated with increased risk for bleeding following mucosal biopsy (e.g., daily high dose aspirin [>81 mg], non-steroidal anti-inflammatory drugs [NSAIDs], or Pradaxa®)
  • Previous use of injectable PrEP
  • ≥ Grade 2 laboratory result for coagulation testing (PT/INR) 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Johns Hopkins University CRS

    Baltimore, Maryland, 21287

  • Alabama CRS (Site ID# 31788)

    Birmingham, Alabama, 35222

  • Fenway Health (FH) CRS

    Boston, Massachusetts, 02215-4302

  • Chapel Hill CRS (3201)

    Chapel Hill, North Carolina, 27599-7215

  • Hope Clinic CRS

    Lawrenceville, Georgia, 30046

  • UCLA CARE Center CRS

    Los Angeles, California, 90035

  • Weill Cornell Chelsea CRS

    New York, New York, 10011

  • University of Pittsburgh CRS

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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

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.

Conditions
Tenofovir
Being tested
Oral F/TDF Pills, TFV rectal douche
Keywords
PrEP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral F/TDF PillsDrug

    For 8 weeks of each study period, the participant will take the study product at least weekly prior to anticipated RAI.

  • TFV rectal doucheDrug

    For 8 weeks of each study period, the participant will take the study product at least weekly prior to anticipated rectal anal intercourse (RAI).

Study groups in NCT06560684
Study groupRoleWhat they receive
Group AExperimentalThose participants assigned to Group A will start with the rectal TFV 660 mg douche for the first 8 weeks (Period 1) and then after a 2-4 week washout will switch to the on-demand oral F/TDF 200 mg/300 mg sequence for the next 8 weeks (Period 2).
Receives: Drug: Oral F/TDF Pills; Drug: TFV rectal douche
Group BExperimentalThose participants assigned to Group B will start with the on-demand oral F/TDF 200 mg/300 mg sequence for 8 weeks and then after a 2-4 week washout will switch to the rectal TFV 660 mg douche for the next 8 weeks (Period 2).
Receives: Drug: Oral F/TDF Pills; Drug: TFV rectal douche

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Grade 2 or higher adverse events during each study Period

    For eGFR, participants may enroll in the study with an eGFR value consistent with a grade 2 adverse event; thus, an exception will be made for eGFR, which will be considered a safety outcome if it worsens to a grade 3 or higher.

    Measured: Week 1 through 19

  2. Any adverse event leading to study product discontinuation during each study Period

    Measured: Week 1 through 19

  3. Self-report on ease of use, product liking, and likelihood of future use during each study Period

    measured via computer-assisted self-interview (CASI), with the scales for the specific questions ranging from 1 (lowest ranking) to 4 (highest ranking).

    Measured: Week 1 through 19

Secondary outcomes (4)

  1. Proportion of participants who reported being most likely to use the TFV douche in the future (following Period 2)

    Measured: Week 1 through 19

  2. Percent prescribed weekly doses taken in each Period using multiple subjective and objective measures

    Measured: Week 1 through 19

  3. TFV and FTC concentrations in blood plasma and rectal tissue biopsies

    (Sub-study only)

    Measured: Week 1 through 19

  4. TFV-DP and FTC-TP concentrations in PBMCs, rectal tissue biopsies, and mucosal mononuclear cells (MMC)

    (Sub-study only)

    Measured: Week 1 through 19

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start29 Oct 2024
  3. Primary completion16 Jun 2026
  4. Study completion16 Jun 2026

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06560684
Sponsor's protocol ID
HPTN 106
Other IDs
39002
Status last verified
Oct 2026
First submitted
2 Aug 2024
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oral F/TDF Pills and TFV rectal douche in people with Tenofovir, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites 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 17 inclusion and 23 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Grade 2 or higher adverse events during each study Period (time frame: Week 1 through 19). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06560684.

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 23 Oct 2026.

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