A randomised non-inferiority trial with nested PK to assess DTG/3TC fixed dose formulations for the maintenance of virological suppression in children with HIV infection aged 2 to <15 years old

Phase 3

Active, not recruiting

• Conditions: HIV-infected

• Registration Number: 2024-520388-15-00
• Lead Sponsor: Fondazione Penta Ets, Fondazione Penta Ets

Brief Summary

To assess whether DTG/3TC is non-inferior to DTG + 2 NRTIs in terms of virological suppression

Detailed Description

This study will include 370 children and young people aged 2 to less than 15 years old who are living with HIV and are being treated with anti-HIV medicines for the first time. Participants will be split into two groups, by chance, by a process called "randomisation". One group will continue to receive the anti-HIV medicines already taken according to country-specific routine practice. The second group will change to the new combination of medicine, dolutegravir and lamivudine (with the combination written usually as "DTG/3TC"). Depending on the weight, participants in the second group will be able take the new medicine either as one tablet a day or as a small number of dispersible tablets that are also taken once a day. All children and young people in the study will have regular clinic assessments that are at a similar frequency to the clinic visits that participants would have outside of the study. Blood tests will be performed to check that the medicine is safe and, at some visits, participants and their carers will also be asked to answer some questions on how they feel about taking their medicine. All children and young people will be followed until the last participant who joins the study has been in the study for 96 weeks.

After 96 weeks, children who were randomised to the DTG/3TC arm will enter the extended follow-up continuing to receive DTG/3TC.

Study Timeline

• Study First Submitted: 2020-03-27
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-07
• Study Start: 2022-04-22
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-29
• Last Update Posted: 2025-09-02
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 386

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of children with confirmed viral rebound (defined as the first of two consecutive HIV-1 RNA ≥50c/mL) by week 96.		Proportion of children with confirmed viral rebound (defined as the first of two consecutive HIV-1 RNA ≥50c/mL) by week 96.

Secondary Outcome Measures

Name	Time	Method
Proportion of children with confirmed viral rebound (defined as the first of two consecutive HIV-1 RNA ≥50c/mL) by week 48.		Proportion of children with confirmed viral rebound (defined as the first of two consecutive HIV-1 RNA ≥50c/mL) by week 48.
Proportion of children with confirmed HIV-1 RNA ≥50c/mL at weeks 48 and 96 (modified FDA snapshot)		Proportion of children with confirmed HIV-1 RNA ≥50c/mL at weeks 48 and 96 (modified FDA snapshot)
Proportion of children with HIV-1 RNA ≥50c/mL at weeks 24, 48 and 96 (including blips and confirmed measures ≥50c/mL)		Proportion of children with HIV-1 RNA ≥50c/mL at weeks 24, 48 and 96 (including blips and confirmed measures ≥50c/mL)
New resistance-associated mutations in those with confirmed HIV-1 RNA ≥50c/mL		New resistance-associated mutations in those with confirmed HIV-1 RNA ≥50c/mL
Time to any new or recurrent WHO 3 or WHO 4 event or death		Time to any new or recurrent WHO 3 or WHO 4 event or death
Change in CD4 (absolute and percentage) from baseline to weeks 24, 48 and 96		Change in CD4 (absolute and percentage) from baseline to weeks 24, 48 and 96
Incidence of serious adverse events, grade ≥3 clinical and laboratory adverse events		Incidence of serious adverse events, grade ≥3 clinical and laboratory adverse events
Incidence of adverse events leading to discontinuation or modification of the treatment regimen		Incidence of adverse events leading to discontinuation or modification of the treatment regimen
Proportion of children with a change in ART for toxicity or switch to second-line		Proportion of children with a change in ART for toxicity or switch to second-line
Change in blood lipids from baseline to weeks 48 and 96		Change in blood lipids from baseline to weeks 48 and 96
Change in creatinine clearance estimated using bedside-Schwartz to weeks 48 and 96		Change in creatinine clearance estimated using bedside-Schwartz to weeks 48 and 96
Adherence as assessed by participant/care-giver questionnaires		Adherence as assessed by participant/care-giver questionnaires
Acceptability, sleep and mood, suicidality ideation and health-related quality of life as assessed by participant/care-giver completed questionnaires		Acceptability, sleep and mood, suicidality ideation and health-related quality of life as assessed by participant/care-giver completed questionnaires

Trial Locations

Locations (2)

Hospital Sant Joan De Deu Barcelona; 🇪🇸 Esplugues De Llobregat, Spain

Hospital Universitario 12 De Octubre; 🇪🇸 Madrid, Spain

Hospital Sant Joan De Deu Barcelona

🇪🇸Esplugues De Llobregat, Spain

Clàudia Fortuny

Site contact

0034932532100

cfortuny@sjdhospitalbarcelona.org