E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Human immunodeficiency virus (HIV) Type 1 |
|
E.1.1.1 | Medical condition in easily understood language |
Human immunodeficiency virus (HIV) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068341 |
E.1.2 | Term | HIV-1 infection |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to assess the acceptability of swallowing the DRV/COBI and D/C/F/TAF FDC
tablets, using matching placebo tablets, in HIV-1 infected adolescent subjects. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective is to assess the acceptability of daily intake of the DRV/COBI and D/C/F/TAF
FDC tablets, by HIV-1 infected adolescent subjects. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject must be male or female between 12 to 17 years of age, inclusive.
2. Subject must have a body weight of at least 40 kg.
3. Informed consent must be obtained (from subject 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 subject is willing to
participate in the study.
4. Subject must be able to comply with the protocol requirements, and adhere to prohibitions
and restrictions specified in this protocol.
5. Subject has documented chronic HIV-1 infection, and is aware of his/her HIV-1 diagnosis. |
|
E.4 | Principal exclusion criteria |
1. Subject has any condition that, in the opinion of the Investigator, would compromise the
study or the well-being of the subject, or prevent the subject from meeting or performing
study requirements.
2. Subject has any condition that, in the opinion of the Investigator, could prevent, limit, or
confound the protocol-specified assessments.
3. Subject has any active clinically significant physical or psychological disease or findings
during screening that, in the Investigator’s opinion, would compromise the subject’s safety,
ability to swallow (eg, candidiasis), or outcome of the study.
4. Subject has history of difficulty with oral intake of ARV therapy or other medications.
5. Subject is taking disallowed concomitant medications or over-the-counter products as noted
in Section 8, Concomitant Therapy. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective is to assess the acceptability of swallowing the DRV/COBI and D/C/F/TAF FDC
tablets, using matching placebo tablets, in HIV-1 infected adolescent subjects.
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
The secondary objective is to assess the acceptability of daily intake of the DRV/COBI and D/C/F/TAF
FDC tablets, by HIV-1 infected adolescent subjects.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
A study to assess the acceptability/swallowability of DRV-containing FDC tablets in HIV-1
infected adolescents, using matching placebo tablets |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Assessment of acceptability/swallowability |
|
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit and last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |