A randomised trial of dolutegravir (DTG)-based antiretroviral treatment vs standard of care (SOC) in children with HIV infection starting first treatment or switching to second-line antiretrovirals

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 700

Inclusion Criteria

? Children <18 years with confirmed HIV-1 infection and DTG dose known for child?s age/weight-band*
? Parents/carers and children, where applicable, give informed written consent
? Girls who have reached menses must have a negative pregnancy test at screening and randomisation and be willing to adhere to effective methods of contraception if sexually active
? Children with co-infections who need to start ART can be enrolled into ODYSSEY according to local/national guidelines
? Parents/carers and children, where applicable, willing to adhere to a minimum of 96 weeks' follow-up

*Recruitment will start from children aged ?6 and<18 years for whom dosing information and formulations are currently available. Additional formulations for younger children will become available during the trial and dosing information will be updated.

Additional criteria for ODYSSEY A:
? Planning to start first-line ART

Additional criteria for ODYSSEY B:
? Planning to start second-line ART defined as switch of at least 2 ART drugs due to treatment failure
? Treated with only one previous ART regimen. Single drug substitutions for toxicity are allowed.
? At least one NRTI with predicted preserved activity available for a background regimen
? In settings where resistance tests are routinely available, at least one new active NRTI from tenofovir, abacavir or zidovudine should have preserved activity based on cumulative results of resistance tests within 3 months
? In settings where resistance tests are not routinely available, children who are due to switch according to national guidelines should have at least one new NRTI available from tenofovir, abacavir or zidovudine
? Viral load >1000 c/ml at screening visit
Are the trial subjects under 18? yes
Number of subjects for this age range: 700
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

? History or presence of known allergy or some other contraindication to the study drugs or their components
? Alanine aminotransferase (ALT) ?5 times the upper limit of normal (ULN), OR ALT ?3xULN and bilirubin ?2xULN
? 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), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
? Anticipated need for Hepatitis C virus (HCV) therapy during the study
? Pregnancy or breastfeeding
? Evidence of lack of susceptibility to integrase inhibitors or more than a 2-week exposure to antiretrovirals of this class
? Contraindications to proposed available NRTI backbone.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate whether treatment with DTG works as well as the standard anti-HIV treatment in children.;Secondary Objective: ? To evaluate if treatment with DTG is better in terms of safety than standard anti-HIV treatment in children.<br>? To compare the adherence to treatment and the quality of life of children receiving DTG to those receiving standard anti-HIV treatment.;Primary end point(s): Difference in the probability of virological or clinical failure at 96 weeks, estimated by Kaplan-Meier methods, using time to the first occurrence of any of the following components: <br>? Insufficient virological response defined as <1 log10 drop at week 24<br>? Viral load >400 c/ml at or after 36 weeks confirmed by next visit<br>? Death due to any cause<br>? Any new or recurrent AIDS defining event (WHO 4) or severe WHO 3 events, confirmed by the Endpoint Review Committee;Timepoint(s) of evaluation of this end point: 96 weeks

Secondary Outcome Measures

Name	Time	Method

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