HIV-1Phase 1NCT02993237
Study to Assess the Acceptability/Swallowability of DRV-Containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets
A Phase 1 study of HIV-1, run by Janssen Research & Development, LLC at 4 sites in United States.
Trial summary
The primary purpose of this study is to assess the acceptability of swallowing the darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human immunodeficiency virus (HIV) -1 infected adolescent… Read more about this study
- Who is it for?
- Ages 12 to 17 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
- 27 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Jan 2017to 25 May 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant must be male or female between 12 to 17 years of age, inclusive
- Participant must have a body weight of at least 40 kilogram (kg)
- Informed consent must be obtained (from participant and/or his/her parent(s)/legal guardian, as applicable) and an age-appropriate Assent Form, as applicable, indicating that the purpose of, and procedures required for, the study are understood and that the participant is willing to participate in the study
- Participant must be able to comply with the protocol requirements, and adhere to prohibitions and restrictions specified in the protocol
- Participant has documented chronic human immunodeficiency virus (HIV) -1 infection, and is aware of his/her HIV-1 diagnosis
- Participant must be on a stable antiretroviral (ARV) regimen for at least 3 months and has documented plasma HIV-1 ribonucleic acid (RNA) less than (<) 50 copies/ milliLitre (mL) within 3 months prior to screening
- Participant must be willing to assess swallowability of the placebo tablets and be able to do so (as demonstrated by the intake of a reference placebo tablet)
Who cannot join
- Participant has any condition that, in the opinion of the Investigator, would compromise the study or the well-being of the participant, or prevent the participant from meeting or performing study requirements
- Participant has any condition that, in the opinion of the Investigator, could prevent, limit, or confound the protocol-specified assessments
- Participant has any active clinically significant physical or psychological disease or findings during screening that, in the Investigator's opinion, would compromise the participant's safety, ability to swallow (eg, candidiasis), or outcome of the study
- Participant has history of difficulty with oral intake of ARV therapy or other medications
- Participant is taking disallowed concomitant medications or over-the-counter products
- Participant is a family member of an employee or Investigator of the study site or Participant is a family member of an employee of Johnson \& Johnson
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University
Atlanta, Georgia, 30350
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
About this study
Official title: A Study to Assess the Acceptability/Swallowability of DRV-containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets
The primary purpose of this study is to assess the acceptability of swallowing the darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human immunodeficiency virus (HIV) -1 infected adolescent patients.
- Conditions
- HIV-1
- Being tested
- DRV/COBI FDC placebo tablet, D/C/F/TAF FDC placebo tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRV/COBI FDC placebo tabletDrug
Participants will receive 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC
D/C/F/TAF FDC placebo tabletsDrug
Participants will receive 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo | Experimental | Participants will receive fixed dose combination (FDC) of darunavir/cobicistat (DRV/COBI) matching placebo tablets (Intake 1) and FDC of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) matching placebo tablets (Intake 2) on Day 1. Both the intakes will be separated by at least 30 minutes. Receives: Drug: DRV/COBI FDC placebo tablet; Drug: D/C/F/TAF FDC placebo tablets |
| Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo | Experimental | Participants will receive FDC of D/C/F/TAF matching placebo tablets (Intake 1) and FDC of DRV/COBI matching placebo tablets (Intake 2) on Day 1. Both the intakes will be separated by at least 30 minutes. Receives: Drug: DRV/COBI FDC placebo tablet; Drug: D/C/F/TAF FDC placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Acceptability of Swallowing Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus (HIV)-1 Infected Adolescent Patients
Swallowability will be assessed based on a 7-point questionnaire indicating how difficult/easy it was to swallow the tablet, ranging from "very difficult" to "very easy". The acceptability proportion is obtained by a dichotomization of the acceptability/swallowability scale, i.e. 'slightly difficult' or worse versus 'neither difficult nor easy' or better.
Measured: Day 1
Secondary outcomes (1)
Acceptability of Daily Intake of the FDC Tablets, by HIV-1 Infected Adolescent Participants
Acceptability for long term daily use will be assessed based on a 3-point questionnaire, 'not acceptable', 'acceptable', or 'good to take'.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start23 Jan 2017
- Primary completion25 May 2017
- Study completion25 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1Studies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993237
- Sponsor's protocol ID
- CR108265
- Other IDs
- TMC114FD2HTX1003, 2016-003016-12, 2016
- Status last verified
- May 2019
- First submitted
- 13 Dec 2016
- Last updated
- 13 May 2019
- 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 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Acceptability/Swallowability of DRV-containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets
- ClinicalTrials.gov ID
- NCT02993237
- Acronym / sponsor ID
- CR108265
- Conditions
- HIV-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 15 Dec 2016 (estimated)
- 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 primary purpose of this study is to assess the acceptability of swallowing the darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human immunodeficiency virus (HIV) -1 infected adolescent patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo | Experimental | Drug: DRV/COBI FDC placebo tablet, Drug: D/C/F/TAF FDC placebo tabletsParticipants will receive fixed dose combination (FDC) of darunavir/cobicistat (DRV/COBI) matching placebo tablets (Intake 1) and FDC of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) matching placebo tablets (Intake 2) on Day 1. Both the intakes will be separated by at least 30 minutes. |
| Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo | Experimental | Drug: DRV/COBI FDC placebo tablet, Drug: D/C/F/TAF FDC placebo tabletsParticipants will receive FDC of D/C/F/TAF matching placebo tablets (Intake 1) and FDC of DRV/COBI matching placebo tablets (Intake 2) on Day 1. Both the intakes will be separated by at least 30 minutes. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Participant must be male or female between 12 to 17 years of age, inclusive
- Participant must have a body weight of at least 40 kilogram (kg)
- Informed consent must be obtained (from participant and/or his/her parent(s)/legal guardian, as applicable) and an age-appropriate Assent Form, as applicable, indicating that the purpose of, and procedures required for, the study are understood and that the participant is willing to participate in the study
- Participant must be able to comply with the protocol requirements, and adhere to prohibitions and restrictions specified in the protocol
- Participant has documented chronic human immunodeficiency virus (HIV) -1 infection, and is aware of his/her HIV-1 diagnosis
Key exclusion criteria (6 listed)
- Participant has any condition that, in the opinion of the Investigator, would compromise the study or the well-being of the participant, or prevent the participant from meeting or performing study requirements
- Participant has any condition that, in the opinion of the Investigator, could prevent, limit, or confound the protocol-specified assessments
- Participant has any active clinically significant physical or psychological disease or findings during screening that, in the Investigator's opinion, would compromise the participant's safety, ability to swallow (eg, candidiasis), or outcome of the study
- Participant has history of difficulty with oral intake of ARV therapy or other medications
- Participant is taking disallowed concomitant medications or over-the-counter products
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 |
|---|---|---|
| DRV/COBI FDC placebo tabletParticipants will receive 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC | Drug | Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo, Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo |
| D/C/F/TAF FDC placebo tabletsParticipants will receive 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC. | Drug | Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo, Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo |
Primary outcome
Proportion of Acceptability of Swallowing Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus (HIV)-1 Infected Adolescent Patients
Time frame: Day 1
Swallowability will be assessed based on a 7-point questionnaire indicating how difficult/easy it was to swallow the tablet, ranging from "very difficult" to "very easy". The acceptability proportion is obtained by a dichotomization of the acceptability/swallowability scale, i.e. 'slightly difficult' or worse versus 'neither difficult nor easy' or better.
1 secondary outcome
Acceptability of Daily Intake of the FDC Tablets, by HIV-1 Infected Adolescent Participants
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- A study to assess the acceptability/swallowability of DRV-containing FDC tablets in HIV-1 infected adolescents, using matching placebo tabletsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of HIV-1, run by Janssen Research & Development, LLC at 4 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 7 inclusion and 6 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 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
Proportion of Acceptability of Swallowing Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus (HIV)-1 Infected Adolescent Patients (time frame: Day 1). 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 May 2019.