CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 792 enrolled
Drug / intervention
Dolutegravir +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/NCT02259127
NCT02259127Phase 3Completed
CompareCT.gov

A Randomised Trial of Dolutegravir (DTG)-Based Antiretroviral Therapy vs. Standard of Care (SOC) in Children With HIV Infection Starting First-line or Switching to Second-line ART

PENTA Foundation·interventional·Posted Oct 8, 2014·Updated Jul 29, 2025

In Brief

A Phase 3 clinical trial evaluating Dolutegravir and Standard of Care for HIV Infection. Completed, enrolled 792 participants across 28 sites in 8 countries.

Detailed Summary

A new anti-HIV medicine (Dolutegravir) combined with 2 currently used anti-HIV medicines is non-inferior to the standard combination of medicines used in terms of efficacy and better in terms of toxicity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
CountriesGermany, Portugal, South Africa, Spain, Thailand, Uganda, United Kingdom, Zimbabwe
CollaboratorsInstitut National de la Santé Et de la Recherche Médicale, France, Program for HIV Prevention and Treatment (PHPT), ViiV Healthcare, MRC CTU at UCL

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 8, 2014
Enrollment StartSep 20, 2016
Primary CompletionMar 2, 2021
Study CompletionDec 7, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 11.7 years ago

Interventions

Dolutegravirdrug

Standard of Caredrug

PI or non nucleoside transcriptase inhibitors