MedTrace Logo

Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial.

NCT03296553 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-01-27

Study results available
· View outcomes & findings →

Summary

Kaposi sarcoma (KS) has an unpredictable course, patients with disseminated KS starting combined Antiretroviral Therapy can develop Immune Reconstitution Syndrome (IRIS), with a severe clinical presentation and high mortality (severe-IRIS-KS). The objective of this study is to evaluate the presence of Severe IRIS-KS and it´s attributable mortality in patients with AIDS and disseminated KS with the use of valganciclovir prior to the initiation of cART compared with the standard management of immediate cART initiation.

Conditions

  • Kaposi Sarcoma
  • Human Immunodeficiency Virus
  • Immune Reconstitution Syndrome

Interventions

DRUG

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.

DRUG

Antiretroviral Combinations

Patients will receive standard antiretroviral treatment as recommended

Sponsors & Collaborators

  • Instituto Nacional de Enfermedades Respiratorias

    collaborator OTHER_GOV

  • National Institute of Cancerología

    lead OTHER_GOV

Principal Investigators

  • Patricia Amalia Volkow Fernández, MD · Instituto Nacional de Cancerologia, Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2019-08-26
Completion
2019-08-26

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03296553 on ClinicalTrials.gov