CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 33 enrolled
Drug / intervention
TRIUMEQ +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04827134
NCT04827134Phase 1Completed
CompareCT.gov

A Randomized, 2-Cohort, 2-Period, Single Dose, Crossover Clinical Study to Assess the Effect of Food on the Pediatric Dispersible Tablet Formulations of TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and DOVATO (Dolutegravir/Lamivudine) in Healthy Adult Participants

ViiV Healthcare·interventional·Posted Apr 1, 2021·Updated Jun 5, 2023

In Brief

A Phase 1 clinical trial evaluating TRIUMEQ and DOVATO for HIV Infections. Completed, enrolled 33 participants across 1 site.

Detailed Summary

This study will assess the effect of food on the pharmacokinetics (PK) of pediatric formulations of TRIUMEQ (dolutegravir \[DTG\] 5 milligrams \[mg\]/abacavir \[ABC\] 60 mg/lamivudine \[3TC\] 30 mg) dispersible tablets and DOVATO (DTG 5 mg/3TC 30 mg) dispersible tablets in healthy adult participants. Additionally, safety and tolerability of these formulations will also be assessed. TRIUMEQ and DOVATO are registered trademarks of GlaxoSmithKline group of companies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedApr 1, 2021
Enrollment StartMay 7, 2021
Primary CompletionJul 23, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.3 years ago

Interventions

TRIUMEQdrug

TRIUMEQ will be available as fixed dose combination (FDC) dispersible tablets to be administered orally as a dispersion.

DOVATOdrug

DOVATO will be available as FDC dispersible tablets to be administered orally as a dispersion.