Status:
COMPLETED
Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial.
Lead Sponsor:
National Institute of Cancerología
Collaborating Sponsors:
Instituto Nacional de Enfermedades Respiratorias
Conditions:
Kaposi Sarcoma
Human Immunodeficiency Virus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 presen...
Detailed Description
Kaposi sarcoma (KS) is a Human Herpes-8 disease, it has been described as an angioproliferative disease mediated by cytokines in an environment of immunodeficiency and thus associated with HIV infecti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03296553
Start Date
October 1 2015
End Date
August 26 2019
Last Update
January 27 2022
Active Locations (1)
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1
Instituto Nacional de Cancerologia
Mexico City, Mexico, 14080