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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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 WeeksSecondary· 96 weeks post randomisation
Proportion of children with viral load suppression \<50 c/ml at 96 weeks.
Group
Value
95% 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 WeeksSecondary· 96 weeks post randomisation
Proportion of children with viral load suppression \<400 c/ml at 96 weeks
Group
Value
95% 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 96Secondary· 96 weeks post randomisation
Reporting mean change from the global baseline value across both arms.
Group
Value
95% 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 96Secondary· 96 weeks post randomisation
Reporting mean change from global baseline value across both arms.
Group
Value
95% 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 EventsSecondary· 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
Group
Value
95% 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 EventsSecondary· 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
Group
Value
95% 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 GradeSecondary· Randomised Phase
Incidence of adverse events (of any grade) leading to treatment modification
Group
Value
95% 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 WeeksSecondary· 48 weeks post randomisation
Treatment failure by 48 weeks. Difference in proportion with clinical or virological failure (as defined above)
Insufficient virologic response
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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 WeeksSecondary· 144 weeks post randomisation
Treatment failure by 144 weeks. Difference in proportion with clinical or virological failure (as defined above)
Insufficient virologic response
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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 DeathSecondary· 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
Group
Value
95% 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 WeeksSecondary· 96 weeks post randomisation
Per protocol: treatment failure by 96 weeks post randomisation
Group
Value
95% 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)
Reaction
System
Dolutegravir (>=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 infestations
Infections and infestations
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Nervous system disorders
Nervous system disorders
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Blood and lymphatic system disorders
Blood and lymphatic system disorders
—
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—
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Psychiatric disorders
Psychiatric disorders
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Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
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Investigations
Investigations
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Renal and urinary disorders
Renal and urinary disorders
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Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
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Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
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Metabolism and nutrition disorders
Metabolism and nutrition disorders
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Vascular disorders
Vascular disorders
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Immune system disorders
Immune system disorders
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Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal conditions
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General disorders and administration site conditions
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):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by PENTA Foundation
Last refreshed: 29 July 2025
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.