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A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants | Clinical Trials | Clareo Health

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A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants

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

NCT04827134•ViiV Healthcare

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent.
•Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
•Body weight \>=50.0 kilograms (kg) (110 pounds \[lbs.\]) for males and \>=45 kg (99 lbs.) for females and body mass index within the range 18.5 to 31.0 kilogram per meter square (kg/m\^2, inclusive).
•A male participant is eligible to participate if they agree to use contraceptive methods.
•A female participant is eligible to participate if she is not pregnant (, not lactating or breastfeeding, and at least 1 of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a non-hormonal contraceptive method that is highly effective
•Capable of giving signed informed consent
•Documentation that the participant is negative for the human leukocyte antigen (HLA) B\*5701 allele.

Exclusion Criteria

•Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
•Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome.
•A pre-existing condition interfering with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study intervention.
•QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 milliseconds (msec).
•A participant with known or suspected active coronavirus disease (COVID-19) infection OR contact with an individual with known COVID-19, within 14 days of study enrollment.
•Presence of hepatitis B surface antigen at screening or within 3 months prior to starting study intervention.
•Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention AND positive on reflex to hepatitis C ribonucleic acid (RNA).
•Positive human immunodeficiency virus (HIV)-1 and -2 antigen/antibody immunoassay at screening.
•Alanine aminotransferase (ALT) \>1.5 × upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility.
•Bilirubin \>1.5 × ULN (isolated bilirubin \>1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility.
+11 more criteria

Locations (1)

GSK Investigational Site

Austin, Texas, United States

Key Dates

Start Date

May 7, 2021

Primary Completion Date

July 23, 2021

Completion Date

July 23, 2021

Last Updated

June 5, 2023

Enrollment

ACTUAL participants

Conditions

HIV Infections

Interventions

TRIUMEQ

DRUG

DOVATO

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 5, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants

Inclusion Criteria

Exclusion Criteria

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