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NCT03760458 · ClinicalTrials.gov registry record · Phase 1
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT03760458: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03760458 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03760458, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
The purpose of this study was to examine the pharmacokinetics, safety, and tolerability of abacavir/dolutegravir/lamivudine dispersible and immediate release tablets in children living with HIV less than 12 years of age.
Primary Outcome
Based on analysis of intensive pharmacokinetic (PK) samples. The geometric mean AUC0-24h for each Weight Band was compared to the lower and upper reference values (in ug\*h/mL) for DTG (35.1, 134), ABC (6.3, 50.4), and 3TC (6.3, 26.5). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.
Interventions
- DRUG Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets
- DRUG Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2020-09-09 |
| Est. Completion | 2022-05-31 |
| Phase | Phase 1 |
What the finished NCT03760458 record still lists
NCT03760458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets is the first listed.
NCT03760458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03760458 about?
NCT03760458 is a clinical study titled "The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age". The purpose of this study was to examine the pharmacokinetics, safety, and tolerability of abacavir/dolutegravir/lamivudine dispersible and immediate release tablets in children living with HIV less than 12 years of age.
What is the current status of trial NCT03760458?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2020-09-09. Estimated completion is 2022-05-31.
What interventions are being tested in trial NCT03760458?
The interventions under investigation include: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets (DRUG), Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release) (DRUG).
Who is sponsoring clinical trial NCT03760458?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03760458's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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