Phase 2 N=40 Randomized Treatment

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

Kaposi Sarcoma · Human Immunodeficiency Virus · Immune Reconstitution Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT03296553 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2022

Primary outcome: Primary: Number of Participants Who Died of Immune Reconstitution Inflammatory Syndrome Associated to Kaposi Sarcoma (IRIS-KS) — 0; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Valganciclovir (Drug); Antiretroviral Combinations (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Cancerología
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Died of Immune Reconstitution Inflammatory Syndrome Associated to Kaposi Sarcoma (IRIS-KS)	0; 3	—

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.

Eligibility Criteria

Inclusion Criteria

Patients will be included with AIDS naïve to antiretroviral therapy and severe KS, who accept to participate and who sign the letter of informed consent.
The following are the KS severity criteria: pulmonary compromise, and/or digestive tract compromise, and/or disseminated cutaneous, and/or lymphadenopathic compromise with generalized lymphedema.

Exclusion Criteria

Patients with another synchronic malignant neoplasm
Patients receiving corticosteroids
Patients with active hepatitis B and/or hepatitis C
Patients with KS limited to skin with less than 30 lesions.
Patients with APACHE II score ≥15 points.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03296553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.