Status:
COMPLETED
ODYSSEY (PENTA 20)
Lead Sponsor:
PENTA Foundation
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Program for HIV Prevention and Treatment (PHPT)
Conditions:
HIV Infection
Eligibility:
All Genders
28-18 years
Phase:
PHASE2
PHASE3
Brief Summary
A new anti-HIV medicine (Dolutegravir) combined with 2 currently used anti-HIV medicines is non-inferior to the standard combination of medicines used in terms of efficacy and better in terms of toxic...
Detailed Description
The ODYSSEY study was an international randomised trial evaluating dolutegravir based antiretroviral therapy (ART) versus standard of care in HIV-infected children aged less than 18 years who were sta...
Eligibility Criteria
Inclusion
- ALL PATIENTS:
- Children ≥28 days and \<18 years weighing ≥3kg with confirmed HIV-1 infection
- Parents/carers and children, where applicable, give informed written consent
- Girls aged 12 years or older who have reached menses must have a negative pregnancy test at screening 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
- Children weighing 3 to \<14kg must be eligible and willing to participate in the Weight band (WB)-Pharmacokinetics (PK)1 substudy unless direct enrolment for the child's weight band has opened following the WB-PK1 substudy and/or dosing information has become available from the IMPAACT P1093 DTG dose-finding study.
- ADDITIONAL CRITERIA FOR ODYSSEY A:
- • Planning to start first-line ART
- ADDITIONAL CRITERIA FOR ODYSSEY B:
- Planning to start second-line ART defined as either: (i) switch of at least 2 ART drugs due to treatment failure; or (ii) switch of only the third agent due to treatment failure where drug sensitivity tests show no mutations conferring Nucleoside Reverse Transcriptase Inhibitor (NRTI) resistance
- Treated with only one previous ART regimen. Single drug substitutions for toxicity, simplification, changes in national guidelines or drug availability 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 disoproxil fumarate, abacavir or zidovudine should have preserved activity based on cumulative results of resistance tests
- 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 predicted to be available from tenofovir disoproxil fumarate, abacavir or zidovudine
- Viral load ≥ 500 c/ml at screening visit
Exclusion
- History or presence of known allergy or contraindications to dolutegravir
- History or presence of known allergy or contraindications to proposed available NRTI backbone or proposed available SOC third agent.
- Alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal, OR ALT ≥3x upper limit of normal and bilirubin ≥2x upper limit of normal
- 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
Key Trial Info
Start Date :
September 20 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2023
Estimated Enrollment :
792 Patients enrolled
Trial Details
Trial ID
NCT02259127
Start Date
September 20 2016
End Date
December 7 2023
Last Update
July 29 2025
Active Locations (28)
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1
Universitata Frankfurt
Frankfurt, Germany
2
UkE Eppendorf Hamburg
Hamburg, Germany
3
Centro Materno-Infantil de Norte
Porto, Portugal
4
King Edward VIII Hospital
Durban, South Africa