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

Conditions

HIV-infected

Brief summary

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

Detailed description

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 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, 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, 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, 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 creatinine clearance estimated using bedside-Schwartz to weeks 48 and 96, 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

Related papers

No related papers found yet.

Interventions

DRUGDescovy 200 mg/25 mg film-coated tablets

DRUGKivexa 600 mg/300 mg film-coated tablets

DRUGTriumeq 50 mg/600 mg/300 mg film-coated tablets

DRUGZiagen 300 mg film-coated tablets

DRUGEpivir 300 mg film-coated tablets

DRUGCombivir 150 mg/300 mg film-coated tablets

DRUGTruvada 200 mg/245 mg film-coated tablets

DRUGRetrovir 250 mg capsules

DRUGhard

DRUGDovato 50 mg/300 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 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, 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, 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, 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 creatinine clearance estimated using bedside-Schwartz to weeks 48 and 96, Adherence as assessed by partici	—

Measure

Time frame

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 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, 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, 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, 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 creatinine clearance estimated using bedside-Schwartz to weeks 48 and 96, Adherence as assessed by partici

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Countries

Spain

Outcome results

None listed