An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa

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.

Conditions

• HIV Infection

Interventions

DRUG

Dolutegravir (DTG)

Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.

DRUG

Abacavir (ABC)

Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.

DRUG

Lamivudine (3TC)

Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.

DRUG

Tenofovir alafenamide (TAF)

Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.

DRUG

Emtricitabine (FTC)

Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.

DRUG

Darunavir (DRV)

Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.

DRUG

Ritonavir (RTV)

Dosage will be by weight band. Adult and paediatric, and single dose/fixed dose combination tablets will be used depending on availability in country and the weight band of the child.

Sponsors & Collaborators

• University of Zimbabwe Clinical Research Centre (UZCRC)

  collaborator UNKNOWN

• Centre for Sexual Health and HIV/AIDS Research Zimbabwe

  collaborator OTHER

• Makerere University

  collaborator OTHER

• PENTA Foundation

  collaborator NETWORK

• Joint Clinical Research Centre- Kampala

  collaborator UNKNOWN

• Eduardo Mondlane University

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• University of York

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• University College, London

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Weeks

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-11-30

Primary Completion

2029-06-30

Completion

2029-12-31