NCT lookup

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.

Eligibility overview

Sex: ALL

Age: 4 Weeks to 14 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

INCLUSION CRITERIA:

1. Aged ≥ 4 weeks to \<15 years\* with confirmed HIV infection
2. Weight ≥3kg and \<30kg\*
3. Written informed consent obtained (and assent if applicable)
4. Willing to adhere to a minimum of 48 weeks' follow-up

* Upper limits of 15 years and 30kg are for initial treatment options and may be amended when further treatment options are introduced (through a protocol amendment)

ART-NAÏVE

1. Planning to start first-line ART
2. Virologically unsuppressed with VL ≥400 c/mL at screening

ART-EXPERIENCED

1. ART-experienced, and on DTG-based ART, and have been on DTG-based ART for at least 6-months prior to screening
2. Virologically unsuppressed for at least 3 months, demonstrated by two consecutive VLs ≥400 c/mL in the last year; the second VL must be at screening
3. Received adherence counselling as per standard practice prior to screening

EXCLUSION CRITERIA

1. Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), OR both ALT ≥3xULN and bilirubin ≥2xULN at screening\*\*
2. 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)
3. Severe renal impairment, defined as creatinine clearance \<30 mL/min/1.73m2, at screening\*\*
4. Severe life-threatening illness (not expected to survive beyond two weeks) as determined by the investigator's clinical judgment.
5. Eligible for less than two permitted treatment options based on tables 3 (ART-naive participants) and 4 (ART-experienced participants)
6. Concurrent participation in another clinical trial of an investigational medicinal product (IMP), medical device or other intervention.

* If ALT, bilirubin or creatinine results are available before randomisation and meet exclusion criteria, the child should not be randomised. However, randomisation may proceed while awaiting these results. If results become available after randomisation and meet exclusion criteria, the participant must be recalled and withdrawn from the trial and the InCTU trial physician contacted to discuss clinical management.