Healthy VolunteerPhase 1DD-PrEP:NCT07349758
Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers
A Phase 1 study testing tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg in people with Healthy Volunteer and HIV Prevention, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of this study is to evaluate the pharmacokinetics of a one-time dosing of two F/TAF tablets over a 14-day period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, HIV Prevention
- What is being tested?
- tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2026to 1 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years of age, inclusive on the date of screening
- Provides written informed consent for the study
- Good general health, as determined by medical history, physical examination, vital signs, screening laboratory tests
- Non-reactive HIV test results within four weeks of enrollment
- An estimated glomerular filtration rate (eGFR) of ≥ 70 mL/min/1.73 m2 via the CKD-EPI 2021 eGFRCr equation
- Agrees to use condoms for all sexual events during study participation
- Willing to abstain from oral PrEP use outside of study products for the duration of the study
Who cannot join
- History of oral PrEP (F/TDF or F/TAF) use in the preceding two months
- Persons who have a reactive or positive HIV result from screening visit.
- Positive hepatitis B surface antigen (HBsAg) test
- Participants with a history of having a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption
- History of any behaviors that place the participant at high-risk for HIV acquisition (e.g., needle sharing, unprotected sex with ≥1 partner in the prior 2 weeks)
- Taking concomitant medications that that are known inducers/inhibitors of P-gp that would effect TAF absorption
- Pregnancy or lactation
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Jennifer Hoffmann, CRNP, 410-955-1318, jhoffm45@jh.edu
Pooja Akoijam, MD, 410-955-1201, pakoija1@jh.edu
About this study
Official title: DD-PrEP: Pharmacokinetic Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers
The goal of this study is to evaluate the pharmacokinetics of a one-time dosing of two F/TAF tablets over a 14-day period.
Read the detailed description
HIV prevention using oral pre-exposure prophylaxis (PrEP) with tenofovir-containing regimens is a promising strategy to reduce the incidence of HIV infection. The study participants will receive a double dose [2 tablets] of Descovy (tenofovir alafenamide [TAF] 25 mg/emtricitabine [FTC] 200mg; F/TAF) and be followed over the course of 14 days. Intensive pharmacokinetic (PK) will occur right after dose administration, and become sparser over the next 14 days. Understanding the PK of TAF, tenofovir (TFV), and FTC and the intracellular metabolites could be used to assess the protective and therapeutic plausibility of alternate, less frequent dosing regimens for PrEP.
- Conditions
- Healthy Volunteer, HIV Prevention
- Being tested
- tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg
- Keywords
- HIV PrEP, healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mgDrug
One-time dose of two F/TAF tablets
| Study group | Role | What they receive |
|---|---|---|
| F/TAF dosing | Experimental | Received one-time dosing of two F/TAF tablets Receives: Drug: tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracellular tenofovir-diphosphate concentrations (fmol/10^6)
Measured: 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start6 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Sunil Solomon, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349758
- Sponsor's protocol ID
- IRB00488588
- Other IDs
- DP1DA060602
- Acronym
- DD-PrEP:
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DD-PrEP: Pharmacokinetic Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07349758
- Acronym / sponsor ID
- DD-PrEP: / IRB00488588
- Conditions
- Healthy Volunteer, HIV Prevention
- Keywords
- HIV PrEP, healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 20 Jan 2026 (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.
The goal of this study is to evaluate the pharmacokinetics of a one-time dosing of two F/TAF tablets over a 14-day period.
Detailed description
HIV prevention using oral pre-exposure prophylaxis (PrEP) with tenofovir-containing regimens is a promising strategy to reduce the incidence of HIV infection. The study participants will receive a double dose [2 tablets] of Descovy (tenofovir alafenamide [TAF] 25 mg/emtricitabine [FTC] 200mg; F/TAF) and be followed over the course of 14 days. Intensive pharmacokinetic (PK) will occur right after dose administration, and become sparser over the next 14 days. Understanding the PK of TAF, tenofovir (TFV), and FTC and the intracellular metabolites could be used to assess the protective and therapeutic plausibility of alternate, less frequent dosing regimens for PrEP.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F/TAF dosing | Experimental | Drug: tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mgReceived one-time dosing of two F/TAF tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years of age, inclusive on the date of screening
- Provides written informed consent for the study
- Good general health, as determined by medical history, physical examination, vital signs, screening laboratory tests
- Non-reactive HIV test results within four weeks of enrollment
- An estimated glomerular filtration rate (eGFR) of ≥ 70 mL/min/1.73 m2 via the CKD-EPI 2021 eGFRCr equation
Key exclusion criteria (8 listed)
- History of oral PrEP (F/TDF or F/TAF) use in the preceding two months
- Persons who have a reactive or positive HIV result from screening visit.
- Positive hepatitis B surface antigen (HBsAg) test
- Participants with a history of having a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption
- History of any behaviors that place the participant at high-risk for HIV acquisition (e.g., needle sharing, unprotected sex with ≥1 partner in the prior 2 weeks)
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 |
|---|---|---|
| tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mgOne-time dose of two F/TAF tablets | Drug | F/TAF dosing |
Primary outcome
Intracellular tenofovir-diphosphate concentrations (fmol/10^6)
Time frame: 168 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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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.
Sunil Solomon, MD principal investigator
Johns Hopkins University
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 tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg in people with Healthy Volunteer and HIV Prevention, run by Johns Hopkins University 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Hoffmann, CRNP (410-955-1318, jhoffm45@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracellular tenofovir-diphosphate concentrations (fmol/10^6) (time frame: 168 hours). 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 13 Feb 2026.