Trial · NCT01837277
Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients
NCT01837277, Phase 2, Phase 3, Completed, Fundação Bahiana de Infectologia; results first posted 2023-12-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients. Trials, record NCT01837277. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01837277
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients
- NCT number
- NCT01837277
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 186 participants, actual
- Lead sponsor
- Fundação Bahiana de Infectologia
- Conditions
- Severely Immunocompromised HIV Patients
- Interventions
- Dolutegravir 50 mg, Efavirenz-based regimens
- First posted
- 2013-04-23
- Last updated
- 2023-12-14
- Results first posted
- 2023-12-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Early Mortality | 6 months | Proportion of deaths in each group |
| Secondary | Viral Load | 24 months | |
| Secondary | CD4 Count | 24 months |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Early Mortality | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Viral Load | 24 months | |||
| SECONDARY | CD4 Count | 24 months |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Early Mortality | Dolutegravir | 9 | Participants | ||
| Early Mortality | Efavirenz | 13 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dolutegravir | 92 | |
| Overall Study | STARTED | Efavirenz | 92 | |
| Overall Study | COMPLETED | Dolutegravir | 70 | |
| Overall Study | COMPLETED | Efavirenz | 48 | |
| Overall Study | NOT COMPLETED | Dolutegravir | 22 | |
| Overall Study | NOT COMPLETED | Efavirenz | 44 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| other | CNS disturbances | Psychiatric disorders | Dolutegravir | 0 | 92 | |
| other | CNS disturbances | Psychiatric disorders | Efavirenz | 11 | 92 | |
| serious | death | General disorders | Dolutegravir | 9 | 92 | |
| serious | death | General disorders | Efavirenz | 13 | 92 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dolutegravir | 9 | 92 |
| Total, all-cause mortality | Efavirenz | 13 | 92 |
| Total, other adverse events | Dolutegravir | 0 | 92 |
| Total, other adverse events | Efavirenz | 11 | 92 |
| Total, serious adverse events | Dolutegravir | 9 | 92 |
| Total, serious adverse events | Efavirenz | 13 | 92 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dolutegravir vs Efavirenz: deaths from any cause | Trial comparisons |
| Dolutegravir vs Efavirenz: Early Mortality | Trial comparisons |
| Dolutegravir vs Efavirenz: serious adverse events | Trial comparisons |
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/NCT01837277
GET https://conductscience.org/api/trials/v1/NCT01837277/registered