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.
Aged ≥ 4 weeks to <15 years* with confirmed HIV infection
Weight ≥3kg and <30kg*
Written informed consent obtained (and assent if applicable)
Willing to adhere to a minimum of 48 weeks' follow-up
Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), OR both ALT ≥3xULN and bilirubin ≥2xULN at screening**
Severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
Severe renal impairment, defined as creatinine clearance <30 mL/min/1.73m2, at screening**
Severe life-threatening illness (not expected to survive beyond two weeks) as determined by the investigator's clinical judgment.
Parallel
Dolutegravir (DTG)
DrugDosage 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.
Abacavir (ABC)
DrugDosage 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.
Lamivudine (3TC)
DrugDosage 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.
Tenofovir alafenamide (TAF)
DrugDosage 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.
Emtricitabine (FTC)
DrugDosage 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.
Darunavir (DRV)
DrugDosage 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.
Ritonavir (RTV)
DrugDosage 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.
7
Treatment groupsSee each treatment group below.
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.
The proportion of participants alive with HIV VL<1000 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.
The proportion of participants with cross-sectional HIV VL ≥50 copies/mL, ≥400 copies/mL, and ≥1000 copies/mL at 48 weeks
Using the single VL measurement closest to the week 48 timepoint within the analysis window (will include blips and confirmed measures).
The proportion of participants with emergent drug resistance by 48 weeks
Time to first serious adverse events (SAEs), grade ≥3 adverse events (AEs) and ART-modifying events of any grade
Adherence and acceptability
Participant or parent/carer reported adherence to trial medications via a short series of questions (Adherence Questionnaire). Participant or parent/carer reported acceptability of trial medications using the Paediatric Oral Medicine Acceptability Questionnaire (POMAQ).
Depression, anxiety, suicidality and sleep
Participant or parent/carer reported depression, anxiety and sleep using a trial-specific Mood and Sleep questionnaire. Participant or parent/carer reported suicidality at screening using the C-SSRS (Columbia-Suicide Severity Rating Scale) Screener questionnaire.
Quality of Life using EQ-5D-Y-5L
Participant and parent/carer reports of health-related quality-of-life using the EuroQol-5 Dimension (EQ-5D) questionnaire. This questionnaire includes a scale of 0-100 where a higher score means a better outcome.
Click on the lead sponsor to view all of their trials.
University College, London
Lead sponsor
University of Zimbabwe Clinical Research Centre (UZCRC)
Collaborator
Centre for Sexual Health and HIV/AIDS Research Zimbabwe
Collaborator
Makerere University
Collaborator
PENTA Foundation
Collaborator
Joint Clinical Research Centre- Kampala
Collaborator
Eduardo Mondlane University
Collaborator
Radboud University Medical Center
Collaborator
University of York
Collaborator
Baylor College of Medicine
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
