Germany, Portugal, South Africa792 participantsStarted 2016-09-20
Plain-language 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.
Who can participate
Age range
28 Days – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1The ODYSSEY trial is a Phase 2/3 study — what does that combination phase mean for how much is already known about the safety and effectiveness of the treatment being tested, and does that affect whether this approach might be right for my situation?
2This trial measured 'failure' as either a clinical setback or virological failure — can you explain what counts as virological failure in this context, and how does the rate of failure in this trial compare to what I might expect from my current or standard treatment options?
3Since this trial is now completed, are the results published, and if so, what did they show about how the experimental arm performed compared to the control group for people with HIV?
4The ODYSSEY trial involved children and adolescents with HIV as well as adults — does the age group most studied in this trial match my profile, and does that affect how relevant the findings are for my care?
5Given that this trial has already completed, is the treatment strategy it tested something my care team could consider for me now, or would I need to look at a different active trial or an approved treatment pathway?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in Proportion With Failure (Clinical or Virological)