Trial · NCT01360762
Prophylaxis of Visceral Leishmaniasis Relapses in HIV Co-infected Patients With Pentamidine: a Cohort Study
NCT01360762, Phase 3, Completed, Institute of Tropical Medicine, Belgium; results first posted 2019-02-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prophylaxis of Visceral Leishmaniasis Relapses in HIV Co-infected Patients With Pentamidine: a Cohort Study. Trials, record NCT01360762. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01360762
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prophylaxis of Visceral Leishmaniasis Relapses in HIV Co-infected Patients With Pentamidine: a Cohort Study
- NCT number
- NCT01360762
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 74 participants, actual
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Conditions
- Visceral Leishmaniosis, HIV-infection/Aids
- Interventions
- Pentamidine
- First posted
- 2011-05-26
- Last updated
- 2019-02-15
- Results first posted
- 2019-02-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Probability of Relapse-free Survival | up to 1 year after the start of the intervention (PSP) | Probability of relapse-free survival up to one year after the start of the intervention (PSP) (at month 6 and month 12) |
| Primary | Number of Participants With Serious Adverse Events (SAEs) | 1 year | Number of patients with SAEs which are possibly, probably or definitely drug-related following clinician's assessment or that lead to permanent drug discontinuations during the first year of pentamidine administration |
| Secondary | Number of Participants With Adverse Events | 1 year | During the first year of pentamidine administration for prophylaxis: participants with any drug-related non-serious adverse events (with drug-related defined as possibly, probably or definitely related to primary therapy following physicians assessment) as well as any serious adverse events (drug-related or not) |
| Secondary | Number of Treatment Discontinuations and Interruptions | 30 months | Number of treatment discontinuations and interruptions/missed doses. |
| Secondary | Number of Required Additional Interventions | 30 months | The number of required additional clinical interventions/therapeutic procedures |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Probability of Relapse-free Survival | up to 1 year after the start of the intervention (PSP) | percentage probability | NUMBER | |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Adverse Events | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Treatment Discontinuations and Interruptions | 30 months | number of events | NUMBER | |
| SECONDARY | Number of Required Additional Interventions | 30 months | number of events | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Probability of Relapse-free Survival | Pentamidine Secondary Prophylaxis (PSP) | Probability of relapse-free survival at 6 months | 79 | 95% Confidence Interval 67 to 87 | percentage probability |
| Probability of Relapse-free Survival | Pentamidine Secondary Prophylaxis (PSP) | Probability of relapse-free survival at 12 months | 71 | 95% Confidence Interval 59 to 80 | percentage probability |
| Number of Participants With Serious Adverse Events (SAEs) | Pentamidine Secondary Prophylaxis (PSP) | 3 | Participants | ||
| Number of Participants With Adverse Events | Pentamidine Secondary Prophylaxis (PSP) | Drug-related non-serious adverse events | 30 | Participants | |
| Number of Participants With Adverse Events | Pentamidine Secondary Prophylaxis (PSP) | Any serious adverse event | 17 | Participants | |
| Number of Treatment Discontinuations and Interruptions | Pentamidine Secondary Prophylaxis (PSP) | Permanent discontinuation | 2 | number of events | |
| Number of Treatment Discontinuations and Interruptions | Pentamidine Secondary Prophylaxis (PSP) | Missed more than 1 dose | 4 | number of events | |
| Number of Treatment Discontinuations and Interruptions | Pentamidine Secondary Prophylaxis (PSP) | Treatment interruption | 0 | number of events | |
| Number of Required Additional Interventions | Pentamidine Secondary Prophylaxis (PSP) | Additional IV fluid during PM administration | 10 | number of events | |
| Number of Required Additional Interventions | Pentamidine Secondary Prophylaxis (PSP) | Prolonged hospital observation | 2 | number of events |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study Period (12-month Treatment) | STARTED | Pentamidine Secondary Prophylaxis (PSP) | 74 | |
| Main Study Period (12-month Treatment) | COMPLETED | Pentamidine Secondary Prophylaxis (PSP) | 45 | |
| Main Study Period (12-month Treatment) | NOT COMPLETED | Pentamidine Secondary Prophylaxis (PSP) | 29 | |
| Whole Study Period | STARTED | Pentamidine Secondary Prophylaxis (PSP) | 74 | |
| Whole Study Period | COMPLETED | Pentamidine Secondary Prophylaxis (PSP) | 38 | |
| Whole Study Period | NOT COMPLETED | Pentamidine Secondary Prophylaxis (PSP) | 36 |
Source ClinicalTrials.gov
Adverse events205
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 | Anaemia | Blood and lymphatic system disorders | Pentamidine Secondary Prophylaxis (PSP) | 9 | 74 | |
| other | Abdominal pain | Gastrointestinal disorders | Pentamidine Secondary Prophylaxis (PSP) | 4 | 74 | |
| other | Diarrhoea | Gastrointestinal disorders | Pentamidine Secondary Prophylaxis (PSP) | 13 | 74 | |
| other | Dyspepsia | Gastrointestinal disorders | Pentamidine Secondary Prophylaxis (PSP) | 11 | 74 | |
| other | Gastritis | Gastrointestinal disorders | Pentamidine Secondary Prophylaxis (PSP) | 9 | 74 | |
| other | Hemorrhoids | Gastrointestinal disorders | Pentamidine Secondary Prophylaxis (PSP) | 4 | 74 | |
| other | Peptic ulcer | Gastrointestinal disorders | Pentamidine Secondary Prophylaxis (PSP) | 4 | 74 | |
| other | Vomiting | Gastrointestinal disorders | Pentamidine Secondary Prophylaxis (PSP) | 5 | 74 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Pentamidine Secondary Prophylaxis (PSP) | 1 | 74 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Pentamidine Secondary Prophylaxis (PSP) | 1 | 74 |
1 to 10 of 205Source ClinicalTrials.gov
See all 205 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pentamidine Secondary Prophylaxis (PSP) | 7 | 74 |
| Total, other adverse events | Pentamidine Secondary Prophylaxis (PSP) | 71 | 74 |
| Total, serious adverse events | Pentamidine Secondary Prophylaxis (PSP) | 33 | 74 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29020217 | DERIVED |
Source PubMed
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/NCT01360762
GET https://conductscience.org/api/trials/v1/NCT01360762/events?page=2