Valganciclovir Four Weeks Prior to cART Initiation Compared to Standard Therapy for Disseminated Kaposi Sarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03296553|
Recruitment Status : Active, not recruiting
First Posted : September 28, 2017
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Kaposi Sarcoma Human Immunodeficiency Virus Immune Reconstitution Syndrome||Drug: Valganciclovir Drug: Antiretroviral Combinations||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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 :||August 10, 2019|
|Estimated Study Completion Date :||August 10, 2019|
Oral Valgancyclovir 900 mg twice in a day during 4 weeks prior to initiation of cART (combined antirretroviral therapy) until suppression of HHV-8.
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
- IRIS-KS-attributable mortality [ Time Frame: 24 weeks ]Measure mortality attributable to IRIS-KS in all the groups
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
|Instituto Nacional de Cancerologia|
|Mexico city, Mexico, 14080|