Trials / Recruiting
RecruitingNCT05674656
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
Phase 1/2 Study of Switching to Fixed Dose Combination Dolutegravir/Rilpivirine Among Virologically Suppressed Children, 6 to Less Than 12 Years of Age, Living With HIV-1
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- ViiV Healthcare · Industry
- Sex
- All
- Age
- 6 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to provide data on the pharmacokinetic (PK), safety, tolerability, efficacy and acceptability of this fixed dose combination (FDC) single tablet 2-drug regimen for virologically suppressed (HIV-1 RNA \[Ribonucleic Acid\] \< 50 \[cells per milliliter\] c/mL) children 6 to less than 12 years of age, weighing at least 25 kilogram (kg).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dolutegravir/Rilpivirine FDC | Dolutegravir/Rilpivirine will be administered. |
Timeline
- Start date
- 2023-07-06
- Primary completion
- 2026-06-01
- Completion
- 2028-05-03
- First posted
- 2023-01-06
- Last updated
- 2024-09-19
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05674656. Inclusion in this directory is not an endorsement.