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HIV-1Phase 1NCT04006704

Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets

A Phase 1 study of HIV-1, run by Janssen Pharmaceutica N.V., Belgium at 8 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

The primary purpose of this study is to assess the ability to swallow the scored film-coated darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablet, irrespective of the mode of intake (whole and split tablet). Read more about this study

Who is it for?
Ages 6 to 11 years
Conditions the study is for
HIV-1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
8 sitesin 2 countries
Study dates
10 Oct 2019to 6 Mar 2020
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 6 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Have a body weight of at least 25 kilogram (kg) and less than (<) 40 kg
  • Has documented chronic human immunodeficiency virus type 1 (HIV-1) infection
  • Must be on a stable antiretroviral (ARV) regimen for at least 3 months prior to screening
  • Has documented plasma HIV-1 ribonucleic acid (RNA) < 400 copies/milliliter (mL) within 6 months prior to screening
  • Parent(s) or their legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older)

Who cannot join

  • Any active condition (example, active oral infection [candidiasis], significant physical or psychological disease or other findings during screening) that could prevent the participant from swallowing, or limit or confound the protocol-specified assessments and outcomes or for which, in the opinion of the investigator, participation could compromise the safety or well-being of the participant
  • Taking any disallowed therapies
  • Is a family member of an employee or investigator of the study site with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of an employee of Johnson \& Johnson
  • Have any known allergies to the excipients of the placebo tablet

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

United States4 sites

  • Emory University

    Atlanta, Georgia, 30308

  • University of Texas Health Science Center

    Houston, Texas, 77030

  • St Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

Other trials in United States

Spain4 sites

  • Hosp. Sant Joan de Deu

    Esplugues de Llobregat, 08950

  • Hosp. Gral. Univ. Gregorio Marañon

    Madrid, 28007

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

Other trials in Spain

About this study

Official title: A Study to Assess the Acceptability of Scored Film-coated Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Tablets in HIV 1 Infected Pediatric Participants Aged ≥6 to <12 Years, Using Matching Placebo Tablets

The primary purpose of this study is to assess the ability to swallow the scored film-coated darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablet, irrespective of the mode of intake (whole and split tablet).

Read the detailed description

This study will be performed in 24 human immunodeficiency virus type 1 (HIV-1) infected pediatric participants. This study is being conducted to obtain data needed to assist in further pediatric development of D/C/F/TAF by assessing the acceptability of the scored film-coated D/C/F/TAF FDC tablet administered as a matching placebo tablet in a pediatric population. At Day 1, each participant will sequentially take 2 placebo tablets and the sequence of placebo tablet, swallowed whole or as split tablet, is assigned by computer generated randomization. After each intake period (within 15 minutes and before the next intake period, as applicable), participants will be asked to fill out an acceptability questionnaires. Every attempt should be made for the participant to complete the questionnaire (marking the correct box to correspond with their impact of taking the placebo tablet). Caregivers may explain the wording/text in the questionnaire to aid in completion. If a participant and his or her caregiver have difficulties in completing the questionnaire, then the study-site personnel may assist. Primarily ability to swallow the scored film-coated D/C/F/TAF FDC tablet, irrespective of the mode of intake will be assessed. Participants safety will be evaluated throughout the study from signing of the Informed Consent Form (ICF)/Assent Form onwards until the last study-related visit.

Conditions
HIV-1
Being tested
D/C/F/TAF FDC placebo

What participants receive

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

  • D/C/F/TAF FDC placeboDrug

    Participants will receive matching placebo tablet (whole and split) of D/C/F/TAF 675/150/200/10 mg FDC on Day 1 as intake period 1 and intake period 2.

Study groups in NCT04006704
Study groupRoleWhat they receive
D/C/F/TAF (Whole Placebo Tablet then Split Placebo Tablet)ExperimentalParticipants will receive scored film-coated 10 milligram (mg) FDC matching placebo tablets (Intake period 1) swallowed whole followed by FDC of scored film-coated D/C/F/TAF 675/150/200/10 mg matching placebo tablets (Intake period 2) swallowed as a split tablet on Day 1. Both the intakes will be separated by at least 15 minutes.
Receives: Drug: D/C/F/TAF FDC placebo
D/C/F/TAF (Split Placebo Tablet then Whole Placebo Tablet)ExperimentalParticipants will receive scored film-coated 10 mg FDC matching placebo tablets (Intake period 1) swallowed as a split tablet followed by FDC of scored film-coated D/C/F/TAF 675/150/200/10 mg matching placebo tablets (Intake period 2) swallowed whole on Day 1. Both the intakes will be separated by at least 15 minutes.
Receives: Drug: D/C/F/TAF FDC placebo

What is being measured

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

  1. Percentage of Participants who are Able to Swallow the Scored Film-Coated D/C/F/TAF FDC Tablet Irrespective of Mode of Intake

    Ability to swallow the scored film-coated tablet irrespective of mode of intake (whole or split tablet) will be assessed.

    Measured: Day 1

Secondary outcomes (7)

  1. Acceptability of Intake of the Whole Tablet by the Participant and by the Caregiver

    Acceptability of intake of whole tablet will be assessed based on a 3-point questionnaire indicating how hard/easy it is to swallow the tablet, ('hard', 'neither hard or easy','easy') to take this pill.

    Measured: Day 1

  2. Acceptability of Intake of the Split Tablet by the Participant and by the Caregiver

    Acceptability of intake of split tablet will be assessed based on a 3-point questionnaire indicating how difficult/easy it was to swallow the tablet ('hard', 'neither hard or easy', 'easy') to take the 2 pieces of this pill.

    Measured: Day 1

  3. Acceptability of Daily Intake of the Whole Tablet by the Participant

    Acceptability of whole tablet describing how it would be if to take this pill once daily for a longer period ('Not Acceptable', 'Acceptable', 'Good to take' to 'Unable to assess this question').

    Measured: Day 1

  4. Acceptability of Daily Intake of the Split Tablet by the Participant

    Acceptability of Split tablet describing how it would be if to take this pill once daily for a longer period ("Not Acceptable', 'Acceptable', 'Good to take' to 'Unable to assess this question').

    Measured: Day 1

  5. Ease of Splitting the Tablet by the Participant's Caregiver

    Ease of splitting the tablet by participant's caregiver will be assessed based on a 3- point questionnaire indicating how difficult was it for the participant's caregiver to break the tablet by hand ('hard', 'ok','easy').

    Measured: Day 1

  6. Number of Participants with Swallowing Difficulties as Reported by the Observer

    Number of Participants with swallowing difficulties as reported by the observer.

    Measured: Day 1

  7. Number of Participants with Adverse Events

    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    Measured: Up to 22 Days

Timeline

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

  1. First posted5 Jul 2019
  2. Study start10 Oct 2019
  3. Primary completion6 Mar 2020
  4. Study completion6 Mar 2020

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04006704
Sponsor's protocol ID
CR108636
Other IDs
2019-001384-68, TMC114FD2HTX1006, 2019
Status last verified
Jun 2021
First submitted
2 Jul 2019
Last updated
6 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

Publications

  • Van Hemelryck S, Van Landuyt E, Hufkens V, Vanveggel S. Assessment of swallowability and acceptability of scored darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets in HIV-1-infected children aged >/=6 to <12 years, using matching placebo tablets: A randomized study. Antivir Ther. 2024 Apr;29(2):13596535241248282. doi: 10.1177/13596535241248282.

    PubMed 38725258

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of HIV-1, run by Janssen Pharmaceutica N.V., Belgium at 8 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 5 inclusion and 4 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 6 Jul 2021. 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, Spain. 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?

Percentage of Participants who are Able to Swallow the Scored Film-Coated D/C/F/TAF FDC Tablet Irrespective of Mode of Intake (time frame: Day 1). 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 NCT04006704, which also lists 1 linked publication.

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 6 Jul 2021.

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