Brief Summary

The goal of the CHAPAS-5 clinical trial is to find out how well different HIV treatments work in children and young people (from 4 weeks up to under 15 years old) living with HIV, including those starting treatment for the first time and those whose current treatment is not working well. The study aims to learn whether newer or different combinations of medicines can better control the virus, be safer, and be easier to take. The main questions it aims to answer are:

Can these treatments help children stay alive and keep their HIV virus at very low levels (viral load below 400) after 48 weeks?
Which treatment options are most effective, safest, and easiest for children and their carers to use? Researchers will compare different treatment groups to see if some medicines work better than others. Participants will be given one of several HIV treatment combinations (all already used in care), and these will be compared to see if they lead to:
Better control of HIV
Fewer side effects
Improved quality of life Participants will:
Be randomly assigned (like flipping a coin by computer) to one suitable HIV treatment
Take their HIV medication every day as prescribed
Attend clinic visits over about 1-2 years At these visits, they will:
Have blood tests to check HIV levels and general health
Have health check-ups (e.g. weight, symptoms, side effects)
Answer simple questionnaires about:
How easy the treatment is to take
Mood, sleep, and wellbeing
Quality of life
Receive support to help them take their medication regularly Some participants may also take part in optional extra studies (for example, to understand how the drugs work in the body). Overall, this study aims to identify the best HIV treatments for children and young people, so future care can be more effective, safer, and easier to follow.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

800

participants targeted

Target at P75+ for phase_3

Timeline

38mo left

Started Nov 2026

Typical duration for phase_3

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.1 years study duration

First Submitted

Initial submission to the registry

July 29, 2026

Completed

1 month until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed

2 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

2.6 years

First QC Date

July 29, 2026

Last Update Submit

August 24, 2026

Conditions

HIV Infection

Keywords

HIVpaediatricpediatricART naiveART experiencedARTAntiretroviral therapyrandomised controlled trialclinical trialPRACTIcal designadaptive trialAfricaUgandaMozambiqueZimbabweHIV infectionphamacokinetics

Outcome Measures

Primary Outcomes (1)

The proportion of participants alive with HIV VL <400 c/mL at 48 weeks
For participants with an initial week 48 VL ≥400 copies/mL, a repeat VL is required, and the repeat value will be used for outcome classification.
Week 48

Secondary Outcomes (7)

The proportion of participants alive with HIV VL<1000 c/mL at 48 weeks
Week 48
The proportion of participants with cross-sectional HIV VL ≥50 copies/mL, ≥400 copies/mL, and ≥1000 copies/mL at 48 weeks
Week 48
The proportion of participants with emergent drug resistance by 48 weeks
Week 48
Time to first serious adverse events (SAEs), grade ≥3 adverse events (AEs) and ART-modifying events of any grade
From randomisation to the last study visit (minimum of 48 weeks)
Time to first new or recurrent WHO 3/4 events, or death
From randomisation to the last study visit (minimum of 48 weeks)
+2 more secondary outcomes

Other Outcomes (3)

Adherence and acceptability
From baseline to last study visit (minimum 48 weeks)
Depression, anxiety, suicidality and sleep
From baseline to last study visit (minimum 48 weeks)
Quality of Life using EQ-5D-Y-5L
From baseline to last study visit (minimum 48 weeks)

Study Arms (7)

ART Naïve DTG/ABC/3TC

EXPERIMENTAL

ART Naïve participants receiving dolutegravir, abacavir, lamivudine

Drug: Dolutegravir (DTG)Drug: Abacavir (ABC)Drug: Lamivudine (3TC)

ART Naïve DTG/TAF/FTC

EXPERIMENTAL

ART Naïve participants receiving dolutegravir, tenofovir alafenamide, emtricitabine

Drug: Dolutegravir (DTG)Drug: Tenofovir alafenamide (TAF)Drug: Emtricitabine (FTC)

ART Naïve DTG/3TC

EXPERIMENTAL

ART Naïve participants receiving dolutegravir, lamivudine

Drug: Dolutegravir (DTG)Drug: Lamivudine (3TC)

ART Experienced DTG/ABC/3TC

EXPERIMENTAL

ART Experienced participants receiving dolutegravir, abacavir, lamivudine

Drug: Dolutegravir (DTG)Drug: Abacavir (ABC)Drug: Lamivudine (3TC)

ART Experienced DTG/TAF/FTC

EXPERIMENTAL

ART Experienced participants receiving dolutegravir, tenofovir alafenamide, emtricitabine

Drug: Dolutegravir (DTG)Drug: Tenofovir alafenamide (TAF)Drug: Emtricitabine (FTC)

ART Experienced DRV/r /ABC/3TC

EXPERIMENTAL

ART Experienced participants receiving darunavir, ritonavir, abacavir, lamivudine

Drug: Abacavir (ABC)Drug: Lamivudine (3TC)Drug: Darunavir (DRV)Drug: Ritonavir (RTV)

ART Experienced DRV/r /TAF/FTC

EXPERIMENTAL

ART Experienced participants receiving darunavir, ritonavir, tenofovir alafenamide, emtricitabine

Drug: Tenofovir alafenamide (TAF)Drug: Emtricitabine (FTC)Drug: Darunavir (DRV)Drug: Ritonavir (RTV)