Trial intelligence / Profile preview

CHAPAS-5: Novel Treatment Regimens in Children and Adolescents With HIV in Africa

NCT07792096Phase 3

Key facts

Status
Not yet recruiting
Start
Nov 2026
Primary completion
Jun 2029
Sponsor
University College London
Conditions
human immunodeficiency virus infection (HIV)
01

Overview

Phase 3, randomised, open-label trial of dolutegravir, abacavir, lamivudine, tenofovir alafenamide, emtricitabine and 2 more in human immunodeficiency virus infection (HIV) (7 arms), sponsored by University College London. Primary endpoint: Proportion of participants alive with HIV Viral Load <400 copies/mL at 48 weeks. Planned start Nov 2026; status: not yet recruiting.

02

Design

7 arms
Study design
RandomizedOpen-label
  • ART Naïve DTG/ABC/3TC

    ART Naïve participants receiving dolutegravir, abacavir, lamivudine

  • ART Naïve DTG/TAF/FTC

    ART Naïve participants receiving dolutegravir, tenofovir alafenamide, emtricitabine

  • ART Naïve DTG/3TC

    ART Naïve participants receiving dolutegravir, lamivudine

  • ART Experienced DTG/ABC/3TC

    ART Experienced participants receiving dolutegravir, abacavir, lamivudine

  • ART Experienced DTG/TAF/FTC

    ART Experienced participants receiving dolutegravir, tenofovir alafenamide, emtricitabine

  • ART Experienced DRV/r /ABC/3TC

    ART Experienced participants receiving darunavir, ritonavir, abacavir, lamivudine

1 more in the full profile.

03

Who it enrols

Children and adolescents aged 4 weeks to <15 years, weighing 3 to <30kg, with confirmed HIV infection, either ART-naive or ART-experienced on DTG-based ART with unsuppressed viral load.

04

Endpoints

Primary

  • Proportion of participants alive with HIV Viral Load <400 copies/mL

Secondary

  • Proportion of participants alive with HIV Viral Load <1000 copies/mL

  • Proportion of participants with cross-sectional HIV Viral Load ≥50, ≥400, and ≥1000 copies/mL

  • Proportion of participants with emergent drug resistance

  • Time to first serious adverse events (SAEs), grade ≥3 adverse events (AEs) and ART-modifying events of any grade

  • Time to first new or recurrent WHO 3/4 events, or death

  • Change in CD4 count and CD4 percentage

  • Change in weight and BMI-for-age

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