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

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ClinicalTrials.gov Identifier: NCT03296553
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : October 2, 2017
Sponsor:
Collaborator:
Instituto Nacional de Enfermedades Respiratorias
Information provided by (Responsible Party):
Volkow Fernandez Patricia Amalia, National Institute of Cancerología

Brief 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.

Condition or disease Intervention/treatment Phase
Kaposi Sarcoma Human Immunodeficiency Virus Immune Reconstitution Syndrome Drug: Valganciclovir Drug: Antiretroviral Combinations Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 1, 2015
Estimated Primary Completion Date : September 12, 2018
Estimated Study Completion Date : October 1, 2018


Arm Intervention/treatment
Experimental: Valganciclovir
Oral Valgancyclovir 900 mg twice in a day during 4 weeks prior to initiation of cART (combined antirretroviral therapy) until suppression of HHV-8.
Drug: Valganciclovir
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.
Other Name: Valcyte

Active Comparator: Antiretroviral combinations
Standard treatment with cART according to current HIV Therapy Mexican guidelines.
Drug: Antiretroviral Combinations
Patients will receive standard antiretroviral treatment as recommended
Other Name: cART




Primary Outcome Measures :
  1. IRIS-KS-attributable mortality [ Time Frame: 24 weeks ]
    Measure mortality attributable to IRIS-KS in all the groups



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296553


Contacts
Contact: Patricia Amalia Volkow Fernández, MD 015256280400 ext 12110 pvolkowf@gmail.com

Locations
Mexico
Instituto Nacional de Cancerologia Recruiting
Mexico city, Mexico, 14080
Contact: Myrna Candelaria, MD, PhD    (52)5556280400 ext 338    candelariamyrna@gmail.com   
Principal Investigator: Myrna Candelaria, MD, PhD.         
Sub-Investigator: Ana Ramirez, MD         
Sub-Investigator: Enrique Estrada, MD         
Sponsors and Collaborators
National Institute of Cancerología
Instituto Nacional de Enfermedades Respiratorias

Responsible Party: Volkow Fernandez Patricia Amalia, Infectious disease consultant, Clinical Professor, National Institute of Cancerología
ClinicalTrials.gov Identifier: NCT03296553     History of Changes
Other Study ID Numbers: (015/031/INI) (CEI/950/15)
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Sarcoma
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Sarcoma, Kaposi
Immune Reconstitution Inflammatory Syndrome
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Vascular Tissue
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents