CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 57 enrolled
Drug / intervention
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets +1 moredrug
Likely dose
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets 60 mgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03760458
NCT03760458Phase 2Completed
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Phase I/II Study of 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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Nov 30, 2018·Updated Jun 27, 2023

In Brief

A Phase 2 clinical trial evaluating Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets and Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release) for HIV Infections. Completed, enrolled 57 participants across 14 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBotswana, South Africa, Thailand, United States
CollaboratorsInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), ViiV Healthcare

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 30, 2018
Enrollment StartSep 9, 2020
Primary CompletionDec 14, 2021
Study CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.6 years ago

Interventions

Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tabletsdrug

Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food

Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release)drug

Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food