Pediatric HIV Infection Clinical Trial
Official title:
Pharmacokinetics, Safety, and Efficacy of Dolutegravir Dispersible Tablets in Young Children Living With HIV
The purpose of this study is to evaluate steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection weighing from 6 to below 20 kg and to determine the dose of DTG that achieves adult target PK parameter(trough concentration; AUC24h)
After being informed about the study and potential risks, all legal guardians giving written informed consent will undergo check eligibility to enroll the study entry. Patients will be sort into 3 weight band groups 6 to below 10 kg, 10 to below 14 kg, and 14 to below 20 kg. ARTs will be switched to DTG dispersible tablet and ABC/3TC once daily will be prescribed according to weight band dosage. Total of 7 time point of blood sampling for plasma DTG concentrations will be measure at 7-14 day after medication switch. Patient will be follow up as schedule for total 24 week to assess safety, and efficacy of DTG dispersible tablet combine with ABC/3TC. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06281834 -
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
|
Phase 1 | |
| Completed |
NCT04206878 -
Evaluating the Feasibility of Point of Care Birth Testing in Eswatini
|
||
| Recruiting |
NCT05069688 -
Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
|
Phase 1 | |
| Active, not recruiting |
NCT03024762 -
Active Search for Pediatric HIV/AIDS (ASPA)
|
N/A | |
| Completed |
NCT04517760 -
Evaluating an HIV Risk Screening Tool for Orphans and Vulnerable Children in Tanzania
|
||
| Not yet recruiting |
NCT03980119 -
Utilizing the HITSystem for Optimizing Paediatric ART Retention and Adherence in Western Nyanza Province, Kenya
|
N/A | |
| Completed |
NCT03824067 -
Impact of Point-of-Care EID for HIV-Exposed Infants
|
N/A |