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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000738-32 | EudraCT Number | ||
| TMC114FD1HTX1001 | Other Identifier | Janssen Research and Development, LLC |
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The purpose of the study is to assess the ability to swallow the Darunavir/Cobicistat (DRV/COBI) fixed dosed combination (FDC) tablet dispersed in water.
Human immunodeficiency virus type 1 (HIV-1) infection is a life-threatening and serious disease that is of major public health interest around the world. Standard-of-care for the treatment of HIV infection involves the use of a combination of antiretroviral (ARV) drugs to suppress viral replication to below detectable limits, to increase CD4+ cell count, and to delay disease progression. Darunavir (DRV) is an inhibitor of the dimerization and of the catalytic activity of the HIV-1 protease. It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in virus infected cells, thereby preventing the formation of mature infectious virus particles. Cobicistat (COBI) is a mechanism-based inhibitor (MBI) of the cytochrome P450 (CYP)3A subfamily. Inhibition of CYP3A mediated metabolism by COBI enhances the systemic exposure of CYP3A substrates, such as DRV, where bioavailability is limited and half-life is shortened by CYP3A-dependent metabolism. DRV/COBI FDC tablet formulation would overcome the difficulties of pediatric participants (greater than or equal to [>=] 3 years and weighing >=15 kilograms [kg] to less than [<] 25 kg) might encounter in swallowing a whole or 2 halves of an oral, non-disintegrating tablet, hence helping children to better adhere to their HIV treatment. The study consists of a screening phase (up to 21 days) and an open-label administration phase of 1 day. Safety will be assessed by adverse events (AEs). The total duration of the study is up to 32 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darunavir/Cobicistat (DRV/COBI) Fixed Dose Combination (FDC) | Experimental | Participants will receive the DRV/COBI FDC tablet for oral use, dispersed in water on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DRV/COBI FDC | Drug | DRV/COBI FDC tablet dispersed in water will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Ability to Take the Darunavir/Cobicistat (DRV/COBI) Fixed Dosed Combination (FDC) Tablet Dispersed in Water as Reported by the Observer | The percentage of participants that is able to swallow the medication fully versus partially or not at all, based on the questionnaire for the observer will be reported. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Swallowing of Tablet Dispersed in Water by the Participant | Ease of Swallowing of tablet dispersed in water by the participant will be assessed by using 5-point hedonic scale acceptability questionnaire to be completed by the participant indicating how difficult/easy it is to swallow the tablet dispersed in water (very difficult, difficult, ok, easy, and very easy). | Day 1 |
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Inclusion Criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research and Development, LLC Clinical Trial | Janssen Research and Development LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30308 | United States | ||
| Rahima Moosa Mother and Child Hospital, University of Witwatersrand |
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
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| Ease of Swallowing of Tablet Dispersed in Water by the Participant as Reported by the Caregiver | Ease of Swallowing of tablet dispersed in water by the participant will be assessed by using 5-point hedonic scale acceptability questionnaire to be completed by the caregiver on the basis of reaction/ facial expression of the participant, indicating how difficult/easy it is for the participant to swallow the tablet dispersed in water (very difficult, difficult, ok, easy, and very easy). | Day 1 |
| Palatability of the Tablet Dispersed in Water by the Participant | Palatability of tablet dispersed in water by the participant will be assessed by using 5-point hedonic scale acceptability questionnaire indicating the taste of the tablet dispersed in water (dislike very much, dislike a little, not sure, like a little, like a lot). | Day 1 |
| Palatability of the Tablet Dispersed in Water by the Participant as Reported by the Caregiver | Palatability of tablet dispersed in water by the participant will be assessed by using 5-point hedonic scale acceptability questionnaire to be completed by the caregiver on the basis of reaction/ facial expression of the participant, indicating how the participant like the taste of the tablet dispersed in water (dislike very much, dislike a little, not sure, like a little, like a lot). | Day 1 |
| Ease of Dispersion of the Tablet in the Water as Reported by the Caregiver | Ease of dispersion of the tablet in the water will be assessed by using 5-point hedonic scale acceptability questionnaire to be completed by the caregiver, indicating how difficult/easy it is to disperse the tablet in water (very difficult, difficult, ok, easy, and very easy). | Day 1 |
| Acceptability of Taking the Tablet Dispersed in Water Everyday by the Participant | Acceptability of taking the tablet dispersed in water everyday by the participant will be assessed by using 5-point hedonic scale acceptability questionnaire indicating how difficult/easy it is to take the tablet everyday (very difficult, difficult, ok, easy, and very easy). | Day 1 |
| Acceptability of Taking the Tablet Dispersed in Water Everyday by the Participant as Reported by the Caregiver | Acceptability of taking the tablet dispersed in water everyday by the participant will be assessed by using 5-point hedonic scale acceptability questionnaire to be completed by the caregiver, indicating how difficult/easy it is for the participant to take the tablet everyday (very difficult, difficult, ok, easy, and very easy). | Day 1 |
| Number of Participants with Adverse Event | 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. | Up to 32 days |
| Johannesburg |
| 2112 |
| South Africa |
| Global Clinical Trials PE | Pretoria | 0001 | South Africa |
| Hosp. Gral. Univ. Gregorio Maranon | Madrid | 28007 | Spain |
| Hosp. Clinico San Carlos | Madrid | 28040 | Spain |
| Hosp. Univ. La Paz | Madrid | 28046 | Spain |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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