Trial · NCT02259127
ODYSSEY (PENTA 20)
NCT02259127, Phase 2, Phase 3, Completed, PENTA Foundation; results first posted 2025-07-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ODYSSEY (PENTA 20). Trials, record NCT02259127. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02259127
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ODYSSEY (PENTA 20)
- NCT number
- NCT02259127
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 792 participants, actual
- Lead sponsor
- PENTA Foundation
- Conditions
- HIV Infection
- Interventions
- Dolutegravir, Standard of Care
- First posted
- 2014-10-08
- Last updated
- 2025-07-29
- Other registries' IDs
- eudract:2014-002632-14
- Results first posted
- 2025-07-29
- Limitations and caveats
- None reported
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in Proportion With Failure (Clinical or Virological) | 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 |
| Secondary | HIV-1 RNA <50c/ml at 96 Weeks | 96 weeks post randomisation | Proportion of children with viral load suppression \<50 c/ml at 96 weeks. |
| Secondary | HIV-1 RNA <400c/mL at 96 Weeks | 96 weeks post randomisation | Proportion of children with viral load suppression \<400 c/ml at 96 weeks |
| Secondary | Mean Change in CD4 Count From Baseline to Week 96 | 96 weeks post randomisation | Reporting mean change from the global baseline value across both arms. |
| Secondary | Mean Change in Total Cholesterol From Baseline to Week 96 | 96 weeks post randomisation | Reporting mean change from global baseline value across both arms. |
| Secondary | Serious Adverse Events | 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 |
| Secondary | Grade 3 or Above Clinical and Laboratory Adverse Events | 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 |
| Secondary | Adverse Events Leading to ART Modification Any Grade | Randomised Phase | Incidence of adverse events (of any grade) leading to treatment modification |
| Secondary | Treatment Failure by 48 Weeks | 48 weeks post randomisation | Treatment failure by 48 weeks. Difference in proportion with clinical or virological failure (as defined above) |
| Secondary | Treatment Failure by 144 Weeks | 144 weeks post randomisation | Treatment failure by 144 weeks. Difference in proportion with clinical or virological failure (as defined above) |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference in Proportion With Failure (Clinical or Virological) | 96 weeks post randomisation | Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | HIV-1 RNA <50c/ml at 96 Weeks | 96 weeks post randomisation | Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | HIV-1 RNA <400c/mL at 96 Weeks | 96 weeks post randomisation | Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in CD4 Count From Baseline to Week 96 | 96 weeks post randomisation | Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13). | cells/mm^3 | MEAN |
| SECONDARY | Mean Change in Total Cholesterol From Baseline to Week 96 | 96 weeks post randomisation | Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13). | mg/dl | MEAN |
| SECONDARY | Serious Adverse Events | 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). | Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13). | participants with events | NUMBER |
| SECONDARY | Grade 3 or Above Clinical and Laboratory Adverse Events | 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). | Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13). | participants with events | NUMBER |
| SECONDARY | Adverse Events Leading to ART Modification Any Grade | Randomised Phase | Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13). | participants with events | NUMBER |
| SECONDARY | Treatment Failure by 48 Weeks | 48 weeks post randomisation | Results not presented by ODYSSEY A and B in \<14kg cohort due to due ODYSSEY B having too few participants (n=13). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Failure by 144 Weeks | 144 weeks post randomisation | Note: analysis could not be performed in \<14kg cohort due to shorter follow-up | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group252
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference in Proportion With Failure (Clinical or Virological) | Dolutegravir (>=14kg Cohort) | Insufficient virological response | 0 | Participants | |
| Difference in Proportion With Failure (Clinical or Virological) | Standard of Care (>=14kg Cohort) | Insufficient virological response | 3 | Participants | |
| Difference in Proportion With Failure (Clinical or Virological) | Dolutegravir (<14kg Cohort) | Insufficient virological response | 0 | Participants | |
| Difference in Proportion With Failure (Clinical or Virological) | Standard of Care (<14kg Cohort) | Insufficient virological response | 0 | Participants | |
| Difference in Proportion With Failure (Clinical or Virological) | Dolutegravir - ODYSSEY A (>=14kg Cohort) | Insufficient virological response | 0 | Participants | |
| Difference in Proportion With Failure (Clinical or Virological) | Standard of Care - ODYSSEY A (>=14kg Cohort) | Insufficient virological response | 2 | Participants | |
| Difference in Proportion With Failure (Clinical or Virological) | Dolutegravir - ODYSSEY B (>=14kg Cohort) | Insufficient virological response | 0 | Participants | |
| Difference in Proportion With Failure (Clinical or Virological) | Standard of Care - ODYSSEY B (>=14kg Cohort) | Insufficient virological response | 1 | Participants | |
| Difference in Proportion With Failure (Clinical or Virological) | Dolutegravir (>=14kg Cohort) | Confirmed VL>=400 copies/mL | 40 | Participants | |
| Difference in Proportion With Failure (Clinical or Virological) | Standard of Care (>=14kg Cohort) | Confirmed VL>=400 copies/mL | 64 | Participants |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dolutegravir (>=14kg Cohort) | 350 | |
| Overall Study | STARTED | Standard of Care (>=14kg Cohort) | 357 | |
| Overall Study | STARTED | Dolutegravir (<14kg Cohort) | 42 | |
| Overall Study | STARTED | Standard of Care (<14kg Cohort) | 43 | |
| Overall Study | ODYSSEY A | Dolutegravir (>=14kg Cohort) | 154 | |
| Overall Study | ODYSSEY A | Standard of Care (>=14kg Cohort) | 157 | |
| Overall Study | ODYSSEY A | Dolutegravir (<14kg Cohort) | 35 | |
| Overall Study | ODYSSEY A | Standard of Care (<14kg Cohort) | 37 | |
| Overall Study | ODYSSEY B | Dolutegravir (>=14kg Cohort) | 196 | |
| Overall Study | ODYSSEY B | Standard of Care (>=14kg Cohort) | 200 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events152
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Vascular disorders | Vascular disorders | Dolutegravir (>=14kg Cohort) | 1 | 350 | |
| serious | Vascular disorders | Vascular disorders | Standard of Care (>=14kg Cohort) | 0 | 357 | |
| serious | Vascular disorders | Vascular disorders | Dolutegravir (<14kg Cohort) | 0 | 42 | |
| serious | Vascular disorders | Vascular disorders | Standard of Care (<14kg Cohort) | 0 | 43 | |
| serious | Vascular disorders | Vascular disorders | Dolutegravir - ODYSSEY A (>=14kg Cohort) | 1 | 154 | |
| serious | Vascular disorders | Vascular disorders | Standard of Care - ODYSSEY A (>=14kg Cohort) | 0 | 157 | |
| serious | Vascular disorders | Vascular disorders | Dolutegravir - ODYSSEY B (>=14kg Cohort) | 0 | 196 | |
| serious | Vascular disorders | Vascular disorders | Standard of Care - ODYSSEY B (>=14kg Cohort) | 0 | 200 | |
| serious | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Dolutegravir (>=14kg Cohort) | 1 | 350 | |
| serious | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Standard of Care (>=14kg Cohort) | 2 | 357 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dolutegravir (>=14kg Cohort) | 2 | 350 |
| Total, all-cause mortality | Standard of Care (>=14kg Cohort) | 3 | 357 |
| Total, all-cause mortality | Dolutegravir (<14kg Cohort) | 2 | 42 |
| Total, all-cause mortality | Standard of Care (<14kg Cohort) | 4 | 43 |
| Total, all-cause mortality | Dolutegravir - ODYSSEY A (>=14kg Cohort) | 2 | 154 |
| Total, all-cause mortality | Standard of Care - ODYSSEY A (>=14kg Cohort) | 2 | 157 |
| Total, all-cause mortality | Dolutegravir - ODYSSEY B (>=14kg Cohort) | 0 | 196 |
| Total, all-cause mortality | Standard of Care - ODYSSEY B (>=14kg Cohort) | 1 | 200 |
| Total, other adverse events | Dolutegravir (>=14kg Cohort) | 0 | 350 |
| Total, other adverse events | Standard of Care (>=14kg Cohort) | 0 | 357 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02259127
GET https://conductscience.org/api/trials/v1/NCT02259127/registered?page=2