HIV InfectionPhase 3CHAPAS-5NCT07792096
An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa
A Phase 3 study testing Dolutegravir (DTG), Abacavir (ABC) and Lamivudine (3TC) in people with HIV Infection, run by University College, London.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 weeks to 14 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- Dolutegravir (DTG), Abacavir (ABC) and Lamivudine (3TC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- 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
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- Planning to start first-line ART
- Virologically unsuppressed with VL ≥400 c/mL at screening
- ART-EXPERIENCED
- ART-experienced, and on DTG-based ART, and have been on DTG-based ART for at least 6-months prior to screening
- 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
- Received adherence counselling as per standard practice prior to screening
Who cannot join
- 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.
- Eligible for less than two permitted treatment options based on tables 3 (ART-naive participants) and 4 (ART-experienced participants)
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: CHAPAS-5: An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa
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.
Read more
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.
Read the detailed description
CHAPAS-5 is a study organised by an international group of researchers from the United Kingdom, Uganda, Mozambique, Zimbabwe, Italy and the Netherlands.
Background HIV is a virus that attacks the cells that help the body fight infection. This means that a person living with HIV may be more likely to become ill as they are not able to fight off other infections and cope with other illnesses. HIV is usually treated by taking three or four different medicines. Some of these medicines can be combined into one tablet. Depending on the medicines used, tablets may need to be taken either once or twice every day. The medicine is called antiretroviral therapy (ART).
The goal of HIV treatment is to make sure the HIV virus in the blood remains very low; this is called virological suppression. If this goal is achieved and sustained life-long, then people with HIV infection can live a healthy life, with a normal life expectancy. Adults living with HIV have many treatment options. This means that they can change treatments more easily if they get side-effects or if a treatment stops working.
Children and adolescents living with HIV have fewer available treatments than adults and only limited alternatives if they develop side-effects or if their current treatment stops working. As HIV treatment needs to be life-long for a person to live a long, healthy and productive life, it is really important that better treatment options are made available to children and adolescents.
A clinical trial is a study that compares different treatments to find out which works best. Traditional trials usually compare only two treatments at a time. CHAPAS-5 uses a newer trial design that can compare several treatments at the same time in two different groups of children. It will test three treatment options for children and adolescents starting ART for the first time (ART-naïve), and four options for those already on ART whose current treatment is not working well (ART-experienced).
Which treatments are being compared?
- Dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) - naive and experienced
- Dolutegravir/tenofovir alafenamide/emtricitabine (DTG/TAF/FTC) - naive and experienced
- Dolutegravir/lamivudine (DTG/3TC) - naive
- Darunavir/ritonavir (DRV/r) + tenofovir alafenamide/emtricitabine (TAF/FTC) - experienced
- Darunavir/ritonavir (DRV/r) + abacavir/lamivudine (ABC/3TC) - experienced
Additional treatments, such as long-acting injectables, may be added to the trial as they become available. These could remove the need for daily pills and help improve adherence.
Who can join the trial? CHAPAS-5 will enrol participants in Uganda, Zimbabwe, and Mozambique.
The study includes children and adolescents aged at least 4 weeks to less than 15 years and weighing 3 to less than 30kg who:
- Are starting ART for the first time, or
- Are already on DTG-based ART but their HIV is not suppressed, and
- Have at least two treatment options in the trial that their doctor considers suitable for them.
What will be measured?
- How well the virus is controlled using a blood test called the viral load
- Side effects from the treatment
- How well children are able to take their treatment as prescribed
- How easy the treatment is to take and how well it fits into daily life
- Mental health and quality of life
- The costs of different treatment options and how cost-effective they are
Participants are followed for at least 48 weeks.
Novel design CHAPAS-5 uses a novel design called the Personalised Randomised Controlled Trial (PRACTical) design. This means that each participant will be randomly allocated to receive a treatment from a list which contains only the treatment options that are appropriate for them. The treatments will be ranked from best performing to worst performing based on how well they work for participants. This will researchers to identify which treatments work best for different groups of children.
Why this trial matters? CHAPAS-5 aims to identify the best treatments for children that work well and are easy to take, with fewer side effects. The trial will also evaluate point-of-care CD4 testing to speed up diagnosis and treatment for children with advanced HIV disease and assess targeted resistance testing to identify those who may need to change treatment.
Broader Implications CHAPAS-5 not only tests different treatment options but aims to speed up the testing of HIV treatments for children so that better options can become available more quickly. The trial findings will help inform national and international guidelines and country treatment policies. This could improve future HIV treatment options for children and adolescents living with HIV.
- Conditions
- HIV Infection
- Being tested
- Dolutegravir (DTG), Abacavir (ABC), Lamivudine (3TC), Tenofovir alafenamide (TAF), Emtricitabine (FTC)
- Keywords
- HIV, paediatric, pediatric, ART naive, ART experienced, ART, Antiretroviral therapy, randomised controlled trial, clinical trial, PRACTIcal design, adaptive trial, Africa, Uganda, Mozambique, Zimbabwe, HIV infection, phamacokinetics
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir (DTG)Drug
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.
Abacavir (ABC)Drug
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.
Lamivudine (3TC)Drug
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.
Tenofovir alafenamide (TAF)Drug
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.
Emtricitabine (FTC)Drug
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.
Darunavir (DRV)Drug
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.
Ritonavir (RTV)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| ART Naïve DTG/ABC/3TC | Experimental | ART Naïve participants receiving dolutegravir, abacavir, lamivudine Receives: Drug: Dolutegravir (DTG); Drug: Abacavir (ABC); Drug: Lamivudine (3TC) |
| ART Naïve DTG/TAF/FTC | Experimental | ART Naïve participants receiving dolutegravir, tenofovir alafenamide, emtricitabine Receives: Drug: Dolutegravir (DTG); Drug: Tenofovir alafenamide (TAF); Drug: Emtricitabine (FTC) |
| ART Naïve DTG/3TC | Experimental | ART Naïve participants receiving dolutegravir, lamivudine Receives: Drug: Dolutegravir (DTG); Drug: Lamivudine (3TC) |
| ART Experienced DTG/ABC/3TC | Experimental | ART Experienced participants receiving dolutegravir, abacavir, lamivudine Receives: Drug: Dolutegravir (DTG); Drug: Abacavir (ABC); Drug: Lamivudine (3TC) |
| ART Experienced DTG/TAF/FTC | Experimental | ART Experienced participants receiving dolutegravir, tenofovir alafenamide, emtricitabine Receives: 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 Receives: 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 Receives: Drug: Tenofovir alafenamide (TAF); Drug: Emtricitabine (FTC); Drug: Darunavir (DRV); Drug: Ritonavir (RTV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 48
Secondary outcomes (7)
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.
Measured: Week 48
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).
Measured: Week 48
The proportion of participants with emergent drug resistance by 48 weeks
Measured: Week 48
Time to first serious adverse events (SAEs), grade ≥3 adverse events (AEs) and ART-modifying events of any grade
Measured: From randomisation to the last study visit (minimum of 48 weeks)
Time to first new or recurrent WHO 3/4 events, or death
Measured: From randomisation to the last study visit (minimum of 48 weeks)
Change in CD4 count and CD4 percentage from baseline to week 48
Measured: From baseline to week 48
Change in weight and BMI-for-age from baseline to week 48
Measured: From baseline to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CHAPAS-5 will use a Personalised Randomised Controlled Trial (PRACTical design) in which each child is randomised only to ART regimens that are clinically appropriate (based on ART-naive/ART-experienced stratum, any resistance test results, use of concomitant medications, and availability of appropriate formulations)
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zimbabwe Clinical Research Centre (UZCRC), Centre for Sexual Health and HIV/AIDS Research Zimbabwe, Makerere University, PENTA Foundation, Joint Clinical Research Centre- Kampala, Eduardo Mondlane University, Radboud University Medical Center, University of York, Baylor College of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792096
- Sponsor's protocol ID
- CHAPAS-5
- Acronym
- CHAPAS-5
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No