CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Valganciclovir +1 moredrug
Likely dose
Valganciclovir 900 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03296553
NCT03296553Phase 2Completed

Valganciclovir for Suppression of HHV-8 Four Weeks Prior to Initiation of cART in Patients With Disseminated Kaposi Sarcoma Compare With Standard Therapy, Its Impact on the Development of IRIS and Attributable Mortality

National Institute of Cancerología·interventional·Posted Sep 28, 2017·Updated Jan 27, 2022

In Brief

A Phase 2 clinical trial evaluating Valganciclovir and Antiretroviral Combinations for Kaposi Sarcoma and 2 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 28, 2017
Enrollment StartOct 1, 2015
Primary CompletionAug 26, 2019
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.8 years ago

Interventions

Valganciclovirdrug

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.

Antiretroviral Combinationsdrug

Patients will receive standard antiretroviral treatment as recommended