NCT02259127

ODYSSEY (PENTA 20)

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 792 (actual)
• Sponsor: PENTA Foundation · Network
• Sex: All
• Age: 28 Days – 18 Years
• Healthy volunteers: Not accepted

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 toxicity.

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 starting first line treatment (ODYSSEY A) or switching to second line treatment (ODYSSEY B). Participants had visits 4 weeks and 12 weeks after randomisation and every 12 weeks subsequent of that. They were followed up for a minimum of 96 weeks. The primary objective of the study was to assess the difference in virological or clinical failure by 96 weeks between children receiving a DTG-based regimen and those on standard of care. At the end of study visit for the randomised phase, children and carers were invited to consent to extended follow-up. Children's visit schedules and care were as per local clinic guidelines. Participants were followed up until July 2023 in this phase of the trial. The objectives of the extended follow-up were two-fold: 1. to provide safety data for ViiV Healthcare for participants who, in the opinion of the treating physician, continue to derive benefit from dolutegravir and receive dolutegravir from ViiV Healthcare where it was not available through their country's national HIV treatment programme; 2. to monitor long-term safety and effectiveness of dolutegravir versus standard of care.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	Dolutegravir
DRUG	Standard of Care	PI or non nucleoside transcriptase inhibitors

Timeline

• Start date: 2016-09-20
• Primary completion: 2021-03-02
• Completion: 2023-12-07
• First posted: 2014-10-08
• Last updated: 2025-07-29
• Results posted: 2025-07-29

Locations

28 sites across 8 countries: Germany, Portugal, South Africa, Spain, Thailand, Uganda, United Kingdom, Zimbabwe