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Comparison · NCT03296553-7af3845e

Valganciclovir vs Antiretroviral Combinations: Number of Participants Who Died of Immune Reconstitution Inflammatory Syndrome Associated to Kaposi Sarcoma (IRIS-KS)

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Valganciclovir vs Antiretroviral Combinations: Number of Participants Who Died of Immune Reconstitution Inflammatory Syndrome Associated to Kaposi Sarcoma (IRIS-KS). Trial comparisons, record NCT03296553-7af3845e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03296553-7af3845e

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.161wilson
Risk in group 20.150.05240.36wilson
Risk difference, group 1 minus group 2-0.15-0.360.0384newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treat, for one fewer participant with the outcome on Valganciclovir than on Antiretroviral Combinations6.67from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Valganciclovir
Oral Valgancyclovir 900 mg twice in a day during 4 weeks prior to initiation of cART (combined antirretroviral therapy) until suppression of HHV-8.~Valganciclovir: The experimental group will receive Valganciclovir 900 mg twice in a day before the initiation of cART until viral load of HHV-8 is undetectable.~20 experimental included 2 eliminated~18 patients included finally.
020OG000
Group 2Antiretroviral Combinations
Standard treatment with cART according to current HIV Therapy Mexican guidelines.~Antiretroviral Combinations: Patients will receive standard antiretroviral treatment as recommended~20 control patients included~1 eliminated~19 patients included finally
320OG001

Outcome

Type
PRIMARY
Title
Number of Participants Who Died of Immune Reconstitution Inflammatory Syndrome Associated to Kaposi Sarcoma (IRIS-KS)
Description
We measured the number of patients who died of IRIS-KS following the definition of IRIS-KS that is specified in the protocol.
Time frame
48 weeks
Population

Source ClinicalTrials.gov

Trial

Title
Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial.
NCT number
NCT03296553
Phases
PHASE2
Conditions
Kaposi Sarcoma, Human Immunodeficiency Virus, Immune Reconstitution Syndrome
Interventions
Valganciclovir, Antiretroviral Combinations
Lead sponsor
National Institute of Cancerología
Results first posted
2022-01-27

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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