Valganciclovir Four Weeks Prior to cART Initiation Compared to Standard Therapy for Disseminated Kaposi Sarcoma

• Status: Unknown status
• Trial end date: 2019-08-10
• Target enrollment: 0
• Participant gender: All

Summary

Kaposi sarcoma (KS) has an unpredictable course, patients with severe KS and low CD4 counts (<100 cells) can develop Immune Reconstitution Syndrome (IRIS) after the initiation of combined Antiretroviral Therapy (cART). The objective of this study is to evaluate the presence of IRIS and its attributable mortality in patients with HIV and severe KS with the use of Ganciclovir or the prodrug Valganciclovir prior to the initiation of cART compared with the standard management of immediate cART initiation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Cancerología
• Collaborator: Instituto Nacional de Enfermedades Respiratorias
• Treatments: Anti-Retroviral Agents; Ganciclovir; Valganciclovir

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.