ODYSSEY: Once daily Dolutegravir in Young people vS Standard thErapY

• Register: ISRCTN
• Last refreshed on: 15 August 2022
• Main ID: ISRCTN91737921
• Date of registration: 08/08/2014
• Prospective Registration: Yes
• Primary sponsor: The PENTA Foundation (Fondazione PENTA Onlus) (Italy)
• Public title: ODYSSEY: Once daily Dolutegravir in Young people vS Standard thErapY
• Scientific title: A randomised trial of dolutegravir (DTG)-based antiretroviral therapy vs standard of care (SOC) in children with HIV infection starting first-line or switching to second-line ART
• Date of first enrolment: 30/06/2015
• Target sample size: 700
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN91737921
• Study type: Interventional
• Study design: Open label multi-centre randomised non-inferiority phase II/III two-arm trial (Treatment)
• Phase: Phase II/III

Countries of recruitment

Albania, Spain

Contacts

• Name: Pablo Rojo Conejo

Key inclusion & exclusion criteria

Inclusion criteria:
1. Children <18 years with confirmed HIV-1 infection
2. Dolutegravir dose known for child?s age/weight-band
3. Parents/carers and children, where applicable, give informed written consent
4. 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
5. In settings where HLA B5701 is available, participants starting ABC as part of the NRTI backbone must be or have been screened and be negative for the HLA-B*5701 allele
6. Children with co-infections who need to start ART can be enrolled into ODYSSEY according to local/national guidelines
7. Parents/carers and children, where applicable, willing to adhere to a minimum of 96 weeks' follow-up

In addition to that, if about to start second-line therapy defined as switch of at least two ART drugs due to treatment failure:
9. At least one NRTI with predicted preserved activity available for a background regimen
10. In settings where resistance tests are routinely available, at least one new active NRTI from TDF, ABC or ZDV should have preserved activity based on cumulative results of resistance tests within 3 months
11. 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 TDF, ABC or ZDV
12. Viral load >1000 copies/ml at screening visit

Exclusion criteria:
1. Alanine aminotransferase (ALT) > 5 times the upper limit of normal (ULN)
2. History or presence of allergy to the study drugs or their components


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

HIV infection
Infections and Infestations
Human immunodeficiency virus [HIV] disease

Intervention(s)

Dolutegravir plus two NRTIs (dolutegravir arm) vs standard of care (SOC arm) in first-line and second-line antiretroviral regimens

Primary Outcome(s)

Difference in proportion with clinical or virological failure at 96 weeks, estimated using time to the first occurrence of any of the following components:
1. Insufficient virological response defined as < 1 log drop at week 24
2. VL>400 copies/ml at or after 36 weeks confirmed by next visit
3. Death due to any cause
4. Any new or recurrent AIDS-defining event (CDC C or WHO 4) or severe/modified CDC B/WHO 3 events, adjudicated by the Endpoint Review Committee (ERC)

Secondary Outcome(s)

Secondary efficacy outcomes:
1. Difference in proportion with clinical or virological failure over 48 weeks
2. Time to any new or recurrent AIDS-defining event (CDC C or WHO 4) or severe/modified CDC B/WHO 3 events after 24 weeks from randomisation, adjudicated by the Endpoint Review Committee (ERC)
3. Proportion of children with VL suppression <50 copies/ml at 48 and 96 weeks
4. Proportion of children with VL suppression <400 copies/ml at 48 and 96 weeks
5. Rate of clinical events over 96 weeks: CDC C/WHO 4, severe CDC B/WHO 3 events and death
6. Change in CD4 count and percentage from baseline to weeks 48 and 96
7. Proportion developing new resistance mutations in those with viral load > 400 c/ml

Secondary safety outcomes:
1. Change in total cholesterol, triglycerides and lipid fractions (LDL, HDL) from baseline to weeks 48 and 96 These safety outcomes will be used to formally assess superiority of dolutegravir-based regimen vs standard of care
2. Incidence of serious adverse events
3. Incidence of new clinical and laboratory grade 3 and 4 adverse events
4. Incidence of adverse events (of any grade) leading to treatment modification

Secondary ID(s)

2014-002632-14

NCT02259127

ODYSSEY (PENTA 20)

Source(s) of Monetary Support

Viiv Healthcare (UK)

Ethics review

Status:
Approval date:
Contact:

Not provided at time of registration

Results

• Results available: Yes
• Date Completed: 30/06/2019