Trial · NCT03296553
Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial.
NCT03296553, Phase 2, Completed, National Institute of Cancerología; results first posted 2022-01-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial. Trials, record NCT03296553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03296553
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial.
- NCT number
- NCT03296553
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- National Institute of Cancerología
- Conditions
- Kaposi Sarcoma, Human Immunodeficiency Virus, Immune Reconstitution Syndrome
- Interventions
- Valganciclovir, Antiretroviral Combinations
- First posted
- 2017-09-28
- Last updated
- 2022-01-27
- Results first posted
- 2022-01-27
- Limitations and caveats
We acknowledge some limitations in our study. First, the sample size was small. And second in estimating the sample size for the trial we overestimated the expected impact of valganciclovir treatment on mortality.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Died of Immune Reconstitution Inflammatory Syndrome Associated to Kaposi Sarcoma (IRIS-KS) | 48 weeks | We measured the number of patients who died of IRIS-KS following the definition of IRIS-KS that is specified in the protocol. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Died of Immune Reconstitution Inflammatory Syndrome Associated to Kaposi Sarcoma (IRIS-KS) | 48 weeks | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Number of Participants Who Died of Immune Reconstitution Inflammatory Syndrome Associated to Kaposi Sarcoma (IRIS-KS) | Valganciclovir | 0 | Participants | ||
| Number of Participants Who Died of Immune Reconstitution Inflammatory Syndrome Associated to Kaposi Sarcoma (IRIS-KS) | Antiretroviral Combinations | 3 | 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 | Valganciclovir | 20 | |
| Overall Study | STARTED | Antiretroviral Combinations | 20 | |
| Overall Study | COMPLETED | Valganciclovir | 18 | |
| Overall Study | COMPLETED | Antiretroviral Combinations | 19 | |
| Overall Study | NOT COMPLETED | Valganciclovir | 2 | |
| Overall Study | NOT COMPLETED | Antiretroviral Combinations | 1 |
Source ClinicalTrials.gov
Adverse events2
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 | Neutropenia <500 cell | Blood and lymphatic system disorders | Valganciclovir | 2 | 18 | 3 |
| other | Neutropenia <500 cell | Blood and lymphatic system disorders | Antiretroviral Combinations | 1 | 19 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Valganciclovir | 3 | 18 |
| Total, all-cause mortality | Antiretroviral Combinations | 3 | 19 |
| Total, other adverse events | Valganciclovir | 2 | 18 |
| Total, other adverse events | Antiretroviral Combinations | 1 | 19 |
| Total, serious adverse events | Valganciclovir | 0 | 18 |
| Total, serious adverse events | Antiretroviral Combinations | 0 | 19 |
Source ClinicalTrials.gov
Papers6
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Valganciclovir vs Antiretroviral Combinations: Number of Participants Who Died of Immune Reconstitution Inflammatory Syndrome Associated to Kaposi Sarcoma (IRIS-KS) | Trial comparisons |
| Valganciclovir vs Antiretroviral Combinations: deaths from any cause | Trial comparisons |
| Valganciclovir vs Antiretroviral Combinations: 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/NCT03296553
GET https://conductscience.org/api/trials/v1/NCT03296553/registered