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Trial record 1 of 1 for:    NCT02259127
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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

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ClinicalTrials.gov Identifier: NCT02259127
Recruitment Status : Recruiting
First Posted : October 8, 2014
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
PENTA Foundation

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 toxicity.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: DTG Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: SOC arm
SOC for ODYSSEY A is defined as a PI or non nucleoside transcriptase inhibitors + 2 or 3 nucleoside transcriptase inhibitor SOC for ODYSSEY B is defined as a PI or non nucleoside transcriptase inhibitor+ 2 nucleoside transcriptase inhibitors
Drug: DTG
Experimental: DTG arm
DTG + 2 nucleoside transcriptase inhibitors
Drug: DTG



Primary Outcome Measures :
  1. Difference in proportion with failure (clinical or virological) [ Time Frame: 96 weeks ]

    estimated using time to the first occurrence of any of the following components:

    • Insufficient virological response defined as < 1 log10 drop at week 24
    • VL>400 c/ml at or after 36 weeks confirmed by next visit
    • Death due to any cause
    • Any new or recurrent AIDS defining event (WHO 4) or severe WHO 3 events, adjudicated by the Endpoint Review Committee


Secondary Outcome Measures :
  1. Difference in proportion with clinical or virological failure (as defined above) [ Time Frame: over 48 weeks. ]
  2. Time to any new or recurrent AIDS defining event (WHO 4) or severe WHO 3 events adjudicated by the Endpoint Review Committee [ Time Frame: after 24 weeks from randomisation ]
  3. Proportion of children with viral load suppression <50 c/ml [ Time Frame: at 48 and 96 weeks ]
  4. Proportion of children with viral load suppression <400 c/ml [ Time Frame: at 48 and 96 weeks ]
  5. Rate of clinical events : WHO 4, severe WHO 3 events and death [ Time Frame: over 96 weeks ]
  6. Change in CD4 count and percentage from baseline [ Time Frame: to weeks 48 and 96 ]
  7. Proportion developing new resistance mutations in those with viral load > 400 c/ml [ Time Frame: 96 weeks ]
  8. Change in total cholesterol, triglycerides and lipid fractions (LDL, HDL) [ Time Frame: from baseline to weeks 48 and 96 ]
  9. Incidence of serious adverse events [ Time Frame: 96 weeks ]
  10. Incidence of new clinical and laboratory grade 3 and 4 adverse events [ Time Frame: 96 weeks ]
  11. Incidence of adverse events (of any grade) leading to treatment modification [ Time Frame: 96 weeks ]


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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

ALL PATIENTS:

  • Children <18 years with confirmed HIV-1 infection and DTG dose known for the child's age/weight-band
  • 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

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
  • 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 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 predicted to be available from tenofovir disoproxil fumarate, abacavir or zidovudine
  • Viral load >1000 c/ml at screening visit

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, OR ALT ≥3x upper limit of normal and bilirubin ≥1.5x 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
  • Contraindications to proposed available NRTI backbone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259127


Contacts
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Contact: Silvia Forcat, PhD 02076704825 S.forcat@ucl.ac.uk

Locations
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South Africa
Kid-Cru Recruiting
Parow, South Africa
PHRU Recruiting
Soweto, South Africa
Uganda
JCRC Recruiting
Kampala, Uganda
MUJHU Recruiting
Kampala, Uganda
JCRC Recruiting
Mbarara, Uganda
Zimbabwe
UZCRC Recruiting
Harare, Zimbabwe
Sponsors and Collaborators
PENTA Foundation

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Responsible Party: PENTA Foundation
ClinicalTrials.gov Identifier: NCT02259127     History of Changes
Other Study ID Numbers: ODYSSEY (PENTA 20)
2014-002632-14 ( EudraCT Number )
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
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Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases