Clinical trial · Interventional
Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial.
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Immunodeficiency Virus | — | UNRESOLVED | — |
| Immune Reconstitution Syndrome | — | UNRESOLVED | — |
| Kaposi Sarcoma | Kaposi Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antiretroviral Combinations | Drug | — | UNRESOLVED |
| Valganciclovir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Valganciclovir
- description
- Oral Valgancyclovir 900 mg twice in a day during 4 weeks prior to initiation of cART (combined antirretroviral therapy) until suppression of HHV-8.
- interventionNames
- Drug: Valganciclovir
- type
- ACTIVE_COMPARATOR
- label
- Antiretroviral combinations
- description
- Standard treatment with cART according to current HIV Therapy Mexican guidelines.
- interventionNames
- Drug: Antiretroviral Combinations
Primary outcomes (1)
- measure
- Number of Participants Who Died of Immune Reconstitution Inflammatory Syndrome Associated to Kaposi Sarcoma (IRIS-KS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDGottlieb GJ, Ragaz A, Vogel JV, Friedman-Kien A, Rywlin AM, Weiner EA, Ackerman AB. A preliminary communication on extensively disseminated Kaposi's sarcoma in young homosexual men. Am J Dermatopathol. 1981 Summer;3(2):111-4. doi: 10.1097/00000372-198100320-00002. No abstract available. PMID 7270808
- BACKGROUNDHymes KB, Cheung T, Greene JB, Prose NS, Marcus A, Ballard H, William DC, Laubenstein LJ. Kaposi's sarcoma in homosexual men-a report of eight cases. Lancet. 1981 Sep 19;2(8247):598-600. doi: 10.1016/s0140-6736(81)92740-9. PMID 6116083
- BACKGROUNDSafai B, Johnson KG, Myskowski PL, Koziner B, Yang SY, Cunningham-Rundles S, Godbold JH, Dupont B. The natural history of Kaposi's sarcoma in the acquired immunodeficiency syndrome. Ann Intern Med. 1985 Nov;103(5):744-50. doi: 10.7326/0003-4819-103-5-744. PMID 3901851
- BACKGROUNDYarchoan R, Uldrick TS. HIV-Associated Cancers and Related Diseases. N Engl J Med. 2018 Mar 15;378(11):1029-1041. doi: 10.1056/NEJMra1615896. PMID 29539283
- BACKGROUNDLacombe JM, Boue F, Grabar S, Viget N, Gazaignes S, Lascaux-Cametz AS, Pacanowski J, Partisani M, Launay O, Matheron S, Rosenthal E, Rouveix E, Tattevin P, de Truchis P, Costagliola D, Goedert JJ. Risk of Kaposi sarcoma during the first months on combination antiretroviral therapy. AIDS. 2013 Feb 20;27(4):635-43. doi: 10.1097/QAD.0b013e32835cba6c. PMID 23196937
- DERIVEDCornejo-Juarez P, Islas-Munoz B, Ramirez-Ibarguen AF, Rosales-Pedraza G, Chavez-Mazari B, Martinez-Orozco A, Volkow-Fernandez P. Bone Marrow Culture Yield for the Diagnosis of Opportunistic Diseases in Patients with AIDS and Disseminated Kaposi Sarcoma. Curr HIV Res. 2020;18(4):277-282. doi: 10.2174/1570162X18666200603145640. PMID 32493198