CompletedPhase 2

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

Mexico40 participantsStarted 2015-10-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Participants Who Died of Immune Reconstitution Inflammatory Syndrome Associated to Kaposi Sarcoma (IRIS-KS)

Timeframe: 48 weeks

Trial details

NCT IDNCT03296553

SponsorNational Institute of Cancerología

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2019-08-26

Results submitted2021-06-23

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