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HIVPhase 1NCT02904369

PK and PD Study of Oral F/TAF for HIV Prevention

A Phase 1 study testing Emtricitabine, Tenofovir alafenamide and Tenofovir disoproxil in people with HIV, run by CONRAD at 3 sites in 2 countries.

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 multi-center Phase I study is designed to characterize the PK and PD of F/TAF oral tablets to assess systemic and genital tract bioavailability in healthy women. The oral tablets to be used in the study are F/TAF (200/10 mg), F/TAF (200/25 mg) and F/TDF (200/300 mg, Truvada). Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
Emtricitabine, Tenofovir alafenamide and Tenofovir disoproxil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
3 sitesin 2 countries
Study dates
6 Oct 2016to 21 Nov 2017
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 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18 to 50 years, inclusive
  • General good health (by volunteer history and per investigator judgment) without any clinically significant systemic disease (including, but not limited to significant liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis or bone disease, and diabetes) and with an intact gastrointestinal tract, uterus and cervix.
  • History of regular menstrual cycles (for cycling women), by volunteer report
  • Estimated calculated creatinine clearance (eCcr) of at least 80 mL/min
  • Body Mass Index (BMI) of ≥18 and <35kg/m2; and a total body weight >45 kg (99.2 lbs)
  • History of Pap smears and follow-up consistent with standard clinical practice as outlined in the Study Manual or willing to undergo a Pap smear at Visit 1
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  • Willing to give voluntary consent and sign an informed consent form
  • Willing and able to comply with protocol requirements, including swallowing tablets
  • May not be using progestin-only hormonal contraception and must be protected from pregnancy by:
  • Condoms
  • Combined hormonal contraceptive (acceptable, but recruitment efforts should be made to limit as much as possible the number of women using them in the study, such that they do not represent the majority of participants.)
  • Copper IUD
  • Sterilization of either partner
  • Heterosexual abstinence
  • Same sex relationship
  • If in a relationship, must be in a mutually monogamous relationship with a partner who is not known to be HIV positive and has no known risk of sexually transmitted infections (STIs)

Who cannot join

  • Currently pregnant
  • Currently breastfeeding or planning to breastfeed during the course of the study
  • History of sensitivity/allergy to any component of the study products, topical anesthetic, or to both silver nitrate and Monsel's solution
  • In the last three months, diagnosed with or treated for any STI
  • Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, HIV, or Hepatitis B surface antigen (HBsAg)
  • Symptomatic bacterial vaginosis (BV)
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  • Current, active Hepatitis C infection
  • Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding, discharge, etc.)
  • Known bleeding disorder that could lead to prolonged or continuous bleeding with biopsy
  • Systemic use in the last two weeks or anticipated use during the study of any of the following: corticosteroids, antibiotics, anticoagulants or other drugs known to prolong bleeding and/or clotting, antifungals, or antivirals or antiretrovirals (e.g. acyclovir, valacyclovir, Viread®, Atripla®, Emtriva®, or Complera®), or drugs that may interact with TAF (e.g., protease inhibitors, anticonvulsants, antimycobacterials, St. John's Wort). See Table 1 from the Patient Information brochure below:
  • Current or anticipated chronic use of NSAIDs or Tylenol for the duration of the study
  • Positive urine drug screen, or known current drug or alcohol abuse which could impact study compliance. Note: therapeutic use of benzodiazepines is acceptable; investigator may discuss with CONRAD participants that may be eligible for enrollment despite a positive drug screen (e.g., false positives, use of cold medications).
  • Participation in any other investigational trial with use of a drug/device within the last 30 days or planned participation in any other investigational with use of a drug/device trial during the study
  • Grade 2 or higher laboratory abnormality, per the 2014 update of the Division of AIDS, National Institute of Allergy and Infectious Disease (DAIDS) Table for Grading the Severity of Adverse Events, or clinically significant laboratory abnormality as determined by the clinician
  • Abnormal finding on laboratory or physical examination or a social or medical condition in the volunteer which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Eastern Virginia Medical School Clinical Research Center

    Norfolk, Virginia, 23507

  • Magee-Womens Research Institute and Foundation

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

Dominican Republic1 site

  • Profamilia

    Santo Domingo

Other trials in Dominican Republic

About this study

Official title: Exploratory Pharmacokinetic and Pharmacodynamic Study of Oral F/TAF for the Prevention of HIV Acquisition

This multi-center Phase I study is designed to characterize the PK and PD of F/TAF oral tablets to assess systemic and genital tract bioavailability in healthy women. The oral tablets to be used in the study are F/TAF (200/10 mg), F/TAF (200/25 mg) and F/TDF (200/300 mg, Truvada). Samples will be obtained before, during and after dosing in two study phases.

Read the detailed description

The purpose of this multi-center Phase I protocol, titled Exploratory Pharmacokinetic and Pharmacodynamic Study of Oral F/TAF for the Prevention of HIV Acquisition is to assess local and systemic pharmacokinetics (PK), pharmacodynamics (PD), and safety characteristics of three oral tablets: F/TAF (200/10 mg), F/TAF (200/25 mg) and F/TDF (200/300 mg).

The study will enroll healthy, non-pregnant, HIV negative, premenopausal women (aged 18-50) who are not at risk of pregnancy and will have two phases: a Single Dose phase (one site only) and a Multiple Dose phase (all three sites).

The enrollment goal is for approximately 72 participants to complete the study. All 72 women are expected to undergo the Multiple Dose phase and the 24 women expected to complete the study at the EVMS site are also expected to undergo the Single Dose phase.

In the Single Dose phase, approximately 24 women will be randomized to one of two products: F/TAF (200/25 mg) or F/TDF (200/300 mg), and will undergo blood, cervicovaginal (CV), and rectal sample collections before and after a single dose for PK and PD assessments. In the Multiple Dose phase, approximately 72 women will be randomized to one of three products: F/TAF (200/10 mg), F/TAF (200/25 mg) or F/TDF (200/300 mg), and will undergo blood, CV, and rectal sample collections for PK and PD assessments before, during and after two weeks of daily dosing.

Conditions
HIV
Being tested
Emtricitabine, Tenofovir alafenamide, Tenofovir disoproxil

What participants receive

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

  • EmtricitabineDrug

  • Tenofovir alafenamideDrug

  • Tenofovir disoproxilDrug

Study groups in NCT02904369
Study groupRoleWhat they receive
F/TAF 200/10ExperimentalEmtricitabine (FTC) + Tenofovir Alafenamide (TAF) (200/10 mg)
Receives: Drug: Emtricitabine; Drug: Tenofovir alafenamide
F/TAF 200/25ExperimentalEmtricitabine (FTC) + Tenofovir Alafenamide (TAF) (200/25 mg)
Receives: Drug: Emtricitabine; Drug: Tenofovir alafenamide
F/TDF 200/300Active comparatorEmtricitabine (FTC) + Tenofovir Disoproxil Fumarate (TDF) (200/300 mg)
Receives: Drug: Emtricitabine; Drug: Tenofovir disoproxil

What is being measured

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

  1. Plasma, cervicovaginal and rectal fluid concentrations of tenofovir alafenamide (TAF), tenofovir (TFV), and emtricitabine (FTC)

    Concentrations after use of study tablets after single dose, and during (plasma) and after two weeks of daily dosing

    Measured: Day 17

  2. PBMC concentrations of tenofovir-diphosphate (TFV-DP), emtricitabine-triphosphate (FTC-TP), deoxyadenosine triphosphate (dATP) and deoxycytidine triphosphate (dCTP)

    Concentrations after use of study tablets after single dose, and during and after two weeks of daily dosing

    Measured: Day 17

  3. Cervicovaginal tissue concentrations of TAF, TFV, FTC, TFV-DP, FTC-TP, dATP and dCTP

    Concentrations after use of study tablets after single dose, and after two weeks of daily dosing

    Measured: Day 17

  4. Pharmacokinetic parameter (Cmax) of F/TAF in the systemic compartment

    Concentrations after use of study tablets after single dose, and during and after two weeks of daily dosing

    Measured: Day 17

  5. p24 antigen production in cervicovaginal and rectal tissue infected with HIV

    p24 antigen production in CV tissue infected with HIV ex vivo after a single dose, and in CV and rectal tissue infected with HIV ex vivo after two weeks of daily dosing compared to baseline

    Measured: Day 17

  6. Anti-HIV activity in cervicovaginal and rectal fluid (TZM-bl inhibition measured as mean percent reduction compared to control)

    Anti-HIV activity in CV and rectal fluid after a single dose, and after two weeks of daily dosing compared to baseline

    Measured: Day 17

  7. Pharmacokinetic parameter (Tmax) of F/TAF in the systemic compartment

    Concentrations after use of study tablets after single dose, and during and after two weeks of daily dosing

    Measured: Day 17

  8. Pharmacokinetic parameter (AUC) of F/TAF in the systemic compartment

    Concentrations after use of study tablets after single dose, and during and after two weeks of daily dosing

    Measured: Day 17

Secondary outcomes (1)

  1. Number of participants with Grade 2 or higher adverse events

    Changes from baseline in adverse events

    Measured: Baseline, Day 17

Timeline

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

  1. First posted19 Sep 2016 (estimated)
  2. Study start6 Oct 2016
  3. Primary completion21 Nov 2017
  4. Study completion21 Nov 2017

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02904369
Sponsor's protocol ID
A15-137
Status last verified
Jan 2018
First submitted
1 Sep 2016
Last updated
19 Feb 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Tompkins LAR, Khoei A, Kapeljushnik O, Dumond J, Kashuba ADM, Tropsha A, Hubal R, Cottrell ML. HIV Pharmacology Data Repository: Setting the New Information-Sharing Standard for Clinical and Preclinical Pharmacokinetic Studies. Clin Pharmacol Ther. 2025 Dec;118(6):1340-1349. doi: 10.1002/cpt.3699. Epub 2025 May 12.

    PubMed 40354181

  • Ouattara LA, Thurman AR, Jacot TA, Cottrell M, Sykes C, Blake K, Fang X, Ju S, Vann NC, Schwartz J, Doncel GF. Genital Mucosal Drug Concentrations and anti-HIV Activity in Tenofovir-Based PrEP Products: Intravaginal Ring vs. Oral Administration. J Acquir Immune Defic Syndr. 2022 Jan 1;89(1):87-97. doi: 10.1097/QAI.0000000000002820.

    PubMed 34878438

  • Thurman AR, Schwartz JL, Cottrell ML, Brache V, Chen BA, Cochon L, Ju S, McGowan I, Rooney JF, McCallister S, Doncel GF. Safety and Pharmacokinetics of a Tenofovir Alafenamide Fumarate-Emtricitabine based Oral Antiretroviral Regimen for Prevention of HIV Acquisition in Women: A Randomized Controlled Trial. EClinicalMedicine. 2021 May 23;36:100893. doi: 10.1016/j.eclinm.2021.100893. eCollection 2021 Jun.

    PubMed 34041459

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Emtricitabine, Tenofovir alafenamide and Tenofovir disoproxil in people with HIV, run by CONRAD at 3 sites in 2 countries.

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 16 inclusion and 15 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Dominican Republic. 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?

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?

Plasma, cervicovaginal and rectal fluid concentrations of tenofovir alafenamide (TAF), tenofovir (TFV), and emtricitabine (FTC) (time frame: Day 17). The study lists 8 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 NCT02904369, which also lists 3 linked publications.

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 19 Feb 2018.

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