A Phase 3 interventional study of Dolutegravir (DTG) and Abacavir (ABC) in HIV Infection, sponsored by University College, London. Not yet recruiting. Open to participants aged 4 Weeks to 14 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by University College, London · Phase 3, Interventional, and Treatment
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Among 55 studies testing dolutegravir in HIV Infections — 7 open to participants now, 9 under way, 4 of them phase 3. Dolutegravir · HIV Infections.
Among the 55 studies testing dolutegravir in HIV Infections, this one is the 4th largest by planned enrollment, is one of 2 that started in 2026, is one of 21 in phase 3, and was the 55th registered.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
Browse HIV Infections studies →7 of the 55 studies testing dolutegravir in HIV Infections are open now, in 12 countries. Recruiting first, the newest first:
ViiV Healthcare · Sites in Romania, South Africa, Uganda
José Antonio Mata Marín · Sites in Mexico
Ages 18–70
Instituto Mexicano del Seguro Social · Sites in Mexico
Ages 18+
José Antonio Mata Marín · Sites in Mexico
Ages 18–70 · Men only
ViiV Healthcare · Sites in United States
Ages 6–12
By country, each count listing its studies:
Dolutegravir: first FDA approval 2013 (TIVICAY), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 4 Weeks to 14 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
55 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 15 · Phase 3 24 · Phase 4 11
First in 2009; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 800 is above the median of 80 across 3,491 interventional studies indexed under HIV Infections.
Median enrollment 126 across the 55 interventional studies. Of the 43 that completed or were terminated, 26 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
28 of 55 have an industry lead sponsor. The 10 most frequent:
University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
University College, London has 3 studies filed under HIV Infections — fewer than ten, so there is no comparison to draw.
1 of the studies testing dolutegravir in HIV Infections that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07031063Instituto Mexicano del Seguro SocialSafety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience | 2026-12-01 |
Add it to your calendar (.ics) → With an account.
Among the 55 studies testing dolutegravir in HIV Infections, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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:
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:
Participants will:
At these visits, they will:
Answer simple questionnaires about:
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.
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?
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:
What will be measured?
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Willing to adhere to a minimum of 48 weeks' follow-up
ART-NAÏVE
ART-EXPERIENCED
EXCLUSION CRITERIA
Concurrent participation in another clinical trial of an medicinal product (IMP), medical device or other intervention.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ART Naïve participants receiving dolutegravir, abacavir, lamivudine
Drug: Dolutegravir (DTG) · Drug: Abacavir (ABC) · Drug: Lamivudine (3TC)
ART Naïve participants receiving dolutegravir, tenofovir alafenamide, emtricitabine
Drug: Dolutegravir (DTG) · Drug: Tenofovir alafenamide (TAF) · Drug: Emtricitabine (FTC)
ART Naïve participants receiving dolutegravir, lamivudine
Drug: Dolutegravir (DTG) · Drug: Lamivudine (3TC)
ART Experienced participants receiving dolutegravir, abacavir, lamivudine
Drug: Dolutegravir (DTG) · Drug: Abacavir (ABC) · Drug: Lamivudine (3TC)
ART Experienced participants receiving dolutegravir, tenofovir alafenamide, emtricitabine
Drug: Dolutegravir (DTG) · Drug: Tenofovir alafenamide (TAF) · Drug: Emtricitabine (FTC)
ART Experienced participants receiving darunavir, ritonavir, abacavir, lamivudine
Drug: Abacavir (ABC) · Drug: Lamivudine (3TC) · Drug: Darunavir (DRV) · Drug: Ritonavir (RTV)
ART Experienced participants receiving darunavir, ritonavir, tenofovir alafenamide, emtricitabine
Drug: Tenofovir alafenamide (TAF) · Drug: Emtricitabine (FTC) · Drug: Darunavir (DRV) · 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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Week 48
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.
Time frame: 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).
Time frame: Week 48
The proportion of participants with emergent drug resistance by 48 weeks
Time frame: Week 48
Time to first serious adverse events (SAEs), grade ≥3 adverse events (AEs) and ART-modifying events of any grade
Time frame: From randomisation to the last study visit (minimum of 48 weeks)
Time to first new or recurrent WHO 3/4 events, or death
Time frame: From randomisation to the last study visit (minimum of 48 weeks)
Change in CD4 count and CD4 percentage from baseline to week 48
Time frame: From baseline to week 48
Change in weight and BMI-for-age from baseline to week 48
Time frame: From baseline to week 48
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).
Time frame: From baseline to last study visit (minimum 48 weeks)
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.
Time frame: From baseline to last study visit (minimum 48 weeks)
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.
Time frame: From baseline to last study visit (minimum 48 weeks)
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Jun 2029, 31 months later.
Of 44 non-industry phase 3 interventional studies under HIV Infections, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 63. This study's planned 31 months is below that.
Counting every sponsor, half of 101 studies reached it within 27 months; a quarter within 20 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dolutegravir · Abacavir · Lamivudine · Tenofovir alafenamide · Emtricitabine · Darunavir · Ritonavir