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NCT02259127

ODYSSEY (PENTA 20)

Completed Phase 2, PHASE3 Results posted Last updated 29 July 2025
What this trial tests

Phase 2, PHASE3 trial testing Dolutegravir in HIV Infection in 792 participants. Completed in 7 December 2023.

Timeline
20 September 2016
Primary endpoint
2 March 2021
7 December 2023

Quick facts

Lead sponsorPENTA Foundation
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment792
Start date20 September 2016
Primary completion2 March 2021
Estimated completion7 December 2023
Sites28 locations across Zimbabwe, South Africa, Uganda, United Kingdom, Germany, Thailand, Portugal, Spain

Drugs / interventions tested

Conditions studied

Sponsor

PENTA Foundation

Who can join

Adults 28 Days to 18, any sex, with HIV Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Difference in Proportion With Failure (Clinical or Virological) Primary · 96 weeks post randomisation

Treatment failure by 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 and switch to second/third line ART for treatment failure * Viral Load (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

Insufficient virological response
GroupValue95% CI
Dolutegravir (>=14kg Cohort)0
Standard of Care (>=14kg Cohort)3
Dolutegravir (<14kg Cohort)0
Standard of Care (<14kg Cohort)0
Dolutegravir - ODYSSEY A (>=14kg Cohort)0
Standard of Care - ODYSSEY A (>=14kg Cohort)2
Dolutegravir - ODYSSEY B (>=14kg Cohort)0
Standard of Care - ODYSSEY B (>=14kg Cohort)1
Confirmed VL>=400 copies/mL
GroupValue95% CI
Dolutegravir (>=14kg Cohort)40
Standard of Care (>=14kg Cohort)64
Dolutegravir (<14kg Cohort)9
Standard of Care (<14kg Cohort)16
Dolutegravir - ODYSSEY A (>=14kg Cohort)10
Standard of Care - ODYSSEY A (>=14kg Cohort)26
Dolutegravir - ODYSSEY B (>=14kg Cohort)30
Standard of Care - ODYSSEY B (>=14kg Cohort)38
Severe WHO 3
GroupValue95% CI
Dolutegravir (>=14kg Cohort)0
Standard of Care (>=14kg Cohort)1
Dolutegravir (<14kg Cohort)0
Standard of Care (<14kg Cohort)0
Dolutegravir - ODYSSEY A (>=14kg Cohort)0
Standard of Care - ODYSSEY A (>=14kg Cohort)0
Dolutegravir - ODYSSEY B (>=14kg Cohort)0
Standard of Care - ODYSSEY B (>=14kg Cohort)1
WHO 4
GroupValue95% CI
Dolutegravir (>=14kg Cohort)7
Standard of Care (>=14kg Cohort)5
Dolutegravir (<14kg Cohort)1
Standard of Care (<14kg Cohort)1
Dolutegravir - ODYSSEY A (>=14kg Cohort)5
Standard of Care - ODYSSEY A (>=14kg Cohort)5
Dolutegravir - ODYSSEY B (>=14kg Cohort)2
Standard of Care - ODYSSEY B (>=14kg Cohort)0
Death
GroupValue95% CI
Dolutegravir (>=14kg Cohort)0
Standard of Care (>=14kg Cohort)2
Dolutegravir (<14kg Cohort)2
Standard of Care (<14kg Cohort)4
Dolutegravir - ODYSSEY A (>=14kg Cohort)0
Standard of Care - ODYSSEY A (>=14kg Cohort)1
Dolutegravir - ODYSSEY B (>=14kg Cohort)0
Standard of Care - ODYSSEY B (>=14kg Cohort)1
HIV-1 RNA <50c/ml at 96 Weeks Secondary · 96 weeks post randomisation

Proportion of children with viral load suppression \<50 c/ml at 96 weeks.

GroupValue95% CI
Dolutegravir (>=14kg Cohort)270
Standard of Care (>=14kg Cohort)252
Dolutegravir (<14kg Cohort)27
Standard of Care (<14kg Cohort)19
Dolutegravir - ODYSSEY A (>=14kg Cohort)117
Standard of Care - ODYSSEY A (>=14kg Cohort)113
Dolutegravir - ODYSSEY B (>=14kg Cohort)153
Standard of Care - ODYSSEY B (>=14kg Cohort)139
HIV-1 RNA <400c/mL at 96 Weeks Secondary · 96 weeks post randomisation

Proportion of children with viral load suppression \<400 c/ml at 96 weeks

GroupValue95% CI
Dolutegravir (>=14kg Cohort)299
Standard of Care (>=14kg Cohort)285
Dolutegravir (<14kg Cohort)33
Standard of Care (<14kg Cohort)26
Dolutegravir - ODYSSEY A (>=14kg Cohort)129
Standard of Care - ODYSSEY A (>=14kg Cohort)124
Dolutegravir - ODYSSEY B (>=14kg Cohort)170
Standard of Care - ODYSSEY B (>=14kg Cohort)161
Mean Change in CD4 Count From Baseline to Week 96 Secondary · 96 weeks post randomisation

Reporting mean change from the global baseline value across both arms.

GroupValue95% CI
Dolutegravir (>=14kg Cohort)265± 17
Standard of Care (>=14kg Cohort)230± 17
Dolutegravir (<14kg Cohort)72± 116
Standard of Care (<14kg Cohort)51± 118
Dolutegravir - ODYSSEY A (>=14kg Cohort)311± 23
Standard of Care - ODYSSEY A (>=14kg Cohort)267± 24
Dolutegravir - ODYSSEY B (>=14kg Cohort)228± 24
Standard of Care - ODYSSEY B (>=14kg Cohort)202± 24
Mean Change in Total Cholesterol From Baseline to Week 96 Secondary · 96 weeks post randomisation

Reporting mean change from global baseline value across both arms.

GroupValue95% CI
Dolutegravir (>=14kg Cohort)-5.0± 1.5
Standard of Care (>=14kg Cohort)9.9± 1.5
Dolutegravir (<14kg Cohort)4.5± 5.6
Standard of Care (<14kg Cohort)29.6± 5.9
Dolutegravir - ODYSSEY A (>=14kg Cohort)2.1± 2.3
Standard of Care - ODYSSEY A (>=14kg Cohort)19.6± 2.3
Dolutegravir - ODYSSEY B (>=14kg Cohort)-10.5± 1.8
Standard of Care - ODYSSEY B (>=14kg Cohort)2.8± 1.8
Serious Adverse Events Secondary · Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort).

Incidence of serious adverse events

GroupValue95% CI
Dolutegravir (>=14kg Cohort)35
Standard of Care (>=14kg Cohort)40
Dolutegravir (<14kg Cohort)11
Standard of Care (<14kg Cohort)11
Dolutegravir - ODYSSEY A (>=14kg Cohort)23
Standard of Care - ODYSSEY A (>=14kg Cohort)27
Dolutegravir - ODYSSEY B (>=14kg Cohort)12
Standard of Care - ODYSSEY B (>=14kg Cohort)13
Grade 3 or Above Clinical and Laboratory Adverse Events Secondary · Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort).

Incidence of new clinical and laboratory grade 3 and 4 adverse events

GroupValue95% CI
Dolutegravir (>=14kg Cohort)73
Standard of Care (>=14kg Cohort)86
Dolutegravir (<14kg Cohort)19
Standard of Care (<14kg Cohort)21
Dolutegravir - ODYSSEY A (>=14kg Cohort)48
Standard of Care - ODYSSEY A (>=14kg Cohort)43
Dolutegravir - ODYSSEY B (>=14kg Cohort)25
Standard of Care - ODYSSEY B (>=14kg Cohort)43
Adverse Events Leading to ART Modification Any Grade Secondary · Randomised Phase

Incidence of adverse events (of any grade) leading to treatment modification

GroupValue95% CI
Dolutegravir (>=14kg Cohort)5
Standard of Care (>=14kg Cohort)17
Dolutegravir (<14kg Cohort)0
Standard of Care (<14kg Cohort)2
Dolutegravir - ODYSSEY A (>=14kg Cohort)3
Standard of Care - ODYSSEY A (>=14kg Cohort)8
Dolutegravir - ODYSSEY B (>=14kg Cohort)2
Standard of Care - ODYSSEY B (>=14kg Cohort)9
Treatment Failure by 48 Weeks Secondary · 48 weeks post randomisation

Treatment failure by 48 weeks. Difference in proportion with clinical or virological failure (as defined above)

Insufficient virologic response
GroupValue95% CI
Dolutegravir (>=14kg Cohort)0
Standard of Care (>=14kg Cohort)3
Dolutegravir (<14kg Cohort)0
Standard of Care (<14kg Cohort)0
Dolutegravir - ODYSSEY A (>=14kg Cohort)0
Standard of Care - ODYSSEY A (>=14kg Cohort)2
Dolutegravir - ODYSSEY B (>=14kg Cohort)0
Standard of Care - ODYSSEY B (>=14kg Cohort)1
Confirmed viral load >400c/ml
GroupValue95% CI
Dolutegravir (>=14kg Cohort)13
Standard of Care (>=14kg Cohort)31
Dolutegravir (<14kg Cohort)4
Standard of Care (<14kg Cohort)11
Dolutegravir - ODYSSEY A (>=14kg Cohort)4
Standard of Care - ODYSSEY A (>=14kg Cohort)12
Dolutegravir - ODYSSEY B (>=14kg Cohort)9
Standard of Care - ODYSSEY B (>=14kg Cohort)19
Severe WHO stage 3
GroupValue95% CI
Dolutegravir (>=14kg Cohort)0
Standard of Care (>=14kg Cohort)1
Dolutegravir (<14kg Cohort)0
Standard of Care (<14kg Cohort)0
Dolutegravir - ODYSSEY A (>=14kg Cohort)0
Standard of Care - ODYSSEY A (>=14kg Cohort)0
Dolutegravir - ODYSSEY B (>=14kg Cohort)0
Standard of Care - ODYSSEY B (>=14kg Cohort)1
WHO stage 4
GroupValue95% CI
Dolutegravir (>=14kg Cohort)7
Standard of Care (>=14kg Cohort)5
Dolutegravir (<14kg Cohort)1
Standard of Care (<14kg Cohort)1
Dolutegravir - ODYSSEY A (>=14kg Cohort)5
Standard of Care - ODYSSEY A (>=14kg Cohort)5
Dolutegravir - ODYSSEY B (>=14kg Cohort)2
Standard of Care - ODYSSEY B (>=14kg Cohort)0
Death
GroupValue95% CI
Dolutegravir (>=14kg Cohort)0
Standard of Care (>=14kg Cohort)2
Dolutegravir (<14kg Cohort)2
Standard of Care (<14kg Cohort)3
Dolutegravir - ODYSSEY A (>=14kg Cohort)0
Standard of Care - ODYSSEY A (>=14kg Cohort)1
Dolutegravir - ODYSSEY B (>=14kg Cohort)0
Standard of Care - ODYSSEY B (>=14kg Cohort)1
Treatment Failure by 144 Weeks Secondary · 144 weeks post randomisation

Treatment failure by 144 weeks. Difference in proportion with clinical or virological failure (as defined above)

Insufficient virologic response
GroupValue95% CI
Dolutegravir (>=14kg Cohort)0
Standard of Care (>=14kg Cohort)3
Dolutegravir - ODYSSEY A (>=14kg Cohort)0
Standard of Care - ODYSSEY A (>=14kg Cohort)2
Dolutegravir - ODYSSEY B (>=14kg Cohort)0
Standard of Care - ODYSSEY B (>=14kg Cohort)1
Confirmed viral load>400c/mL
GroupValue95% CI
Dolutegravir (>=14kg Cohort)48
Standard of Care (>=14kg Cohort)76
Dolutegravir - ODYSSEY A (>=14kg Cohort)13
Standard of Care - ODYSSEY A (>=14kg Cohort)28
Dolutegravir - ODYSSEY B (>=14kg Cohort)35
Standard of Care - ODYSSEY B (>=14kg Cohort)48
Severe WHO stage 3
GroupValue95% CI
Dolutegravir (>=14kg Cohort)0
Standard of Care (>=14kg Cohort)1
Dolutegravir - ODYSSEY A (>=14kg Cohort)0
Standard of Care - ODYSSEY A (>=14kg Cohort)0
Dolutegravir - ODYSSEY B (>=14kg Cohort)0
Standard of Care - ODYSSEY B (>=14kg Cohort)1
WHO stage 4
GroupValue95% CI
Dolutegravir (>=14kg Cohort)8
Standard of Care (>=14kg Cohort)5
Dolutegravir - ODYSSEY A (>=14kg Cohort)6
Standard of Care - ODYSSEY A (>=14kg Cohort)5
Dolutegravir - ODYSSEY B (>=14kg Cohort)2
Standard of Care - ODYSSEY B (>=14kg Cohort)0
Death
GroupValue95% CI
Dolutegravir (>=14kg Cohort)0
Standard of Care (>=14kg Cohort)2
Dolutegravir - ODYSSEY A (>=14kg Cohort)0
Standard of Care - ODYSSEY A (>=14kg Cohort)1
Dolutegravir - ODYSSEY B (>=14kg Cohort)0
Standard of Care - ODYSSEY B (>=14kg Cohort)1
WHO 4, Severe WHO 3 Events and Death Secondary · Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort).

Rate of clinical events : WHO 4, severe WHO 3 events and death

GroupValue95% CI
Dolutegravir (>=14kg Cohort)8
Standard of Care (>=14kg Cohort)8
Dolutegravir (<14kg Cohort)3
Standard of Care (<14kg Cohort)6
Dolutegravir - ODYSSEY A (>=14kg Cohort)6
Standard of Care - ODYSSEY A (>=14kg Cohort)6
Dolutegravir - ODYSSEY B (>=14kg Cohort)2
Standard of Care - ODYSSEY B (>=14kg Cohort)2
Per Protocol: Treatment Failure by 96 Weeks Secondary · 96 weeks post randomisation

Per protocol: treatment failure by 96 weeks post randomisation

GroupValue95% CI
Dolutegravir (>=14kg Cohort)44
Standard of Care (>=14kg Cohort)62
Dolutegravir (<14kg Cohort)12
Standard of Care (<14kg Cohort)20
Dolutegravir - ODYSSEY A (>=14kg Cohort)13
Standard of Care - ODYSSEY A (>=14kg Cohort)28
Dolutegravir - ODYSSEY B (>=14kg Cohort)31
Standard of Care - ODYSSEY B (>=14kg Cohort)34

Adverse events — posted to ClinicalTrials.gov

Time frame: Randomised phase: follow-up was censored when the last participant reached 96 weeks of follow-up (142 weeks (IQR:124 to 159) in ≥14kg cohort and 124 weeks (112 to 137) in <14kg cohort).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dolutegravir (>=14kg Cohort)
Serious: 35/350 (10%)
Deaths: 2/350
Standard of Care (>=14kg Cohort)
Serious: 40/357 (11%)
Deaths: 3/357
Dolutegravir (<14kg Cohort)
Serious: 11/42 (26%)
Deaths: 2/42
Standard of Care (<14kg Cohort)
Serious: 11/43 (26%)
Deaths: 4/43
Dolutegravir - ODYSSEY A (>=14kg Cohort)
Serious: 23/154 (15%)
Deaths: 2/154
Standard of Care - ODYSSEY A (>=14kg Cohort)
Serious: 27/157 (17%)
Deaths: 2/157
Dolutegravir - ODYSSEY B (>=14kg Cohort)
Serious: 12/196 (6%)
Deaths: 0/196
Standard of Care - ODYSSEY B (>=14kg Cohort)
Serious: 13/200 (7%)
Deaths: 1/200

Serious adverse events (19 terms)

ReactionSystemDolutegravir (>=14kg Cohort)Standard of Care (>=14kg C…Dolutegravir (<14kg Cohort)Standard of Care (<14kg Co…Dolutegravir - ODYSSEY A (…Standard of Care - ODYSSEY…Dolutegravir - ODYSSEY B (…Standard of Care - ODYSSEY…
Infections and infestationsInfections and infestations
Nervous system disordersNervous system disorders
Blood and lymphatic system disordersBlood and lymphatic system disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Psychiatric disordersPsychiatric disorders
Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications
InvestigationsInvestigations
Renal and urinary disordersRenal and urinary disorders
Skin and subcutaneous tissue disordersSkin and subcutaneous tissue disorders
Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders
Metabolism and nutrition disordersMetabolism and nutrition disorders
Vascular disordersVascular disorders
Immune system disordersImmune system disorders
Pregnancy, puerperium and perinatal conditionsPregnancy, puerperium and perinatal conditions
General disorders and administration site conditionsGeneral disorders
Cardiac disordersCardiac disorders
Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders
Gastrointestinal disordersGastrointestinal disorders
Hepatobiliary disordersHepatobiliary disorders

Most-reported serious reactions: Infections and infestations, Nervous system disorders, Blood and lymphatic system disorders, Neoplasms benign, malignant and unspecified (incl cysts and polyps), Psychiatric disorders, Injury, poisoning and procedural complications, Investigations, Renal and urinary disorders.

Data from ClinicalTrials.gov NCT02259127 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children.
    Turkova A, White E, Mujuru HA, Kekitiinwa AR, et al · · 2021 · cited 106× · PMID 34965338 · DOI 10.1056/nejmoa2108793
  2. Simplified dolutegravir dosing for children with HIV weighing 20 kg or more: pharmacokinetic and safety substudies of the multicentre, randomised ODYSSEY trial.
    Bollen PDJ, Moore CL, Mujuru HA, Makumbi S, et al · · 2020 · cited 38× · PMID 32763217 · DOI 10.1016/s2352-3018(20)30189-2
  3. ODYSSEY clinical trial design: a randomised global study to evaluate the efficacy and safety of dolutegravir-based antiretroviral therapy in HIV-positive children, with nested pharmacokinetic sub-studies to evaluate pragmatic WHO-weight-band based dolutegravir dosing.
    Moore CL, Turkova A, Mujuru H, Kekitiinwa A, et al · · 2021 · cited 34× · PMID 33446115 · DOI 10.1186/s12879-020-05672-6
  4. Pharmacokinetics, safety, tolerability, and antiviral activity of dolutegravir dispersible tablets in infants and children with HIV-1 (IMPAACT P1093): results of an open-label, phase 1-2 trial.
    Ruel TD, Acosta EP, Liu JP, Gray KP, et al · · 2022 · cited 33× · PMID 35489377 · DOI 10.1016/s2352-3018(22)00044-3
  5. Dolutegravir dosing for children with HIV weighing less than 20 kg: pharmacokinetic and safety substudies nested in the open-label, multicentre, randomised, non-inferiority ODYSSEY trial.
    Waalewijn H, Chan MK, Bollen PDJ, Mujuru HA, et al · · 2022 · cited 31× · PMID 35189082 · DOI 10.1016/s2352-3018(21)00292-7
  6. "Because we all have to grow up": supporting adolescents in Uganda to develop core competencies to transition towards managing their HIV more independently.
    Lanyon C, Seeley J, Namukwaya S, Musiime V, et al · · 2020 · cited 30× · PMID 32869514 · DOI 10.1002/jia2.25552
  7. Once-daily dolutegravir-based antiretroviral therapy in infants and children living with HIV from age 4 weeks: results from the below 14 kg cohort in the randomised ODYSSEY trial.
    Amuge P, Lugemwa A, Wynne B, Mujuru HA, et al · · 2022 · cited 24× · PMID 36055295 · DOI 10.1016/s2352-3018(22)00163-1
  8. Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial.
    Turkova A, Waalewijn H, Chan MK, Bollen PDJ, et al · · 2022 · cited 21× · PMID 35868341 · DOI 10.1016/s2352-3018(22)00160-6

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02259127.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing