BridgeMD
A randomised non-inferiority trial with nested PK to assess DTG/3TC fixed dose formulations for the maintenance of virological suppression in children with HIV infection aged 2 to <15 years old
EU CTIS ID: 2024-520388-15-00
What this study is testing
To assess whether DTG/3TC is non-inferior to DTG + 2 NRTIs in terms of virological suppression
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- HIV-1 infected children who are virologically suppressed for at least the last 6 months prior to enrolment
- Aged 2 to <15 years old
- Weight 6 kg or higher
- Girls who have reached menarche must have a negative pregnancy test at screening and randomisation
- Girls who are sexually active must be willing to adhere to highly effective methods of contraception
- A parent or legal guardian is willing and able to give informed consent on behalf of the child as per national legislation and willing to adhere to the protocol
You likely can't join if
- Any previous switch in ART regimen for virological, immunological or clinical treatment failure
- Screening ALT equal to 5 or more times the upper limit of normal ALT (≥5xULN)
- Patients with severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Screening creatinine clearance <30 mL/min/1.73m2
- Patients aged ≥6 years at moderate or high risk of suicide as determined by Columbia-Suicide Severity Rating Scale (C-SSRS)
- Girls who are pregnant or breastfeeding
See the full eligibility criteria
- HIV-1 infected children who are virologically suppressed for at least the last 6 months prior to enrolment
- Aged 2 to <15 years old
- Weight 6 kg or higher
- Girls who have reached menarche must have a negative pregnancy test at screening and randomisation
- Girls who are sexually active must be willing to adhere to highly effective methods of contraception
- A parent or legal guardian is willing and able to give informed consent on behalf of the child as per national legislation and willing to adhere to the protocol
- Participant is willing to give informed assent if the trial site clinician deems them old enough and able to understand the age-appropriate information about participation in the study
- Any previous switch in ART regimen for virological, immunological or clinical treatment failure
- Screening ALT equal to 5 or more times the upper limit of normal ALT (≥5xULN)
- Patients with severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Screening creatinine clearance <30 mL/min/1.73m2
- Patients aged ≥6 years at moderate or high risk of suicide as determined by Columbia-Suicide Severity Rating Scale (C-SSRS)
- Girls who are pregnant or breastfeeding
- Children who are in the legal custody of the state and do not have a parent or guardian able to provide informed consent on their behalf
- Evidence of previous resistance to 3TC or INSTI
- Any prior use of regimens consisting of single or dual NRTIs with the exception of a course of zidovudine for prevention of mother to child transmission
- Known allergy or contraindications to dolutegravir or lamivudine
- Diagnosis of tuberculosis and on anti-tuberculosis treatment; children can be enrolled after successful tuberculosis treatment
- Treatment of co-morbidities with drugs which have significant interactions with antiretroviral treatment, requiring dose adjustment of the study drugs (children can be enrolled after the illness resolves)
- Randomisation visit more than 12 weeks after the most recent screening visit
- Positive HBsAg
- Screening ALT equal to 3 or more times the upper limit of normal AND bilirubin equal to 2 or more times the upper limit of normal (ALT ≥3xULN AND bilirubin ≥2xULN)
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- United Kingdom
- South Africa
- Uganda
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; United Kingdom; South Africa; Uganda. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.