Oral Valganciclovir Versus Valacyclovir
|First Submitted Date ICMJE||November 20, 2007|
|First Posted Date ICMJE||November 22, 2007|
|Last Update Posted Date||July 31, 2012|
|Start Date ICMJE||September 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||CBC, platelet and differential. BUN, creatinine, total bilirubin, alkaline phosphatase, LDH, SGPT [ Time Frame: CBC, platelet and differential 2 weeks +/- 3 days for 8 weeks, and every 4 weeks +/- 3 days during the remainder of therapy. BUN, creatinine, total bilirubin, alkaline phosphatase, LDH, SGPT every 4 weeks +/- 3 days. ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00562770 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||CMV antigenemia [ Time Frame: CMV antigenemia every 2 weeks +/- 3 days for 3 months ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Oral Valganciclovir Versus Valacyclovir|
|Official Title ICMJE||Open Label, Phase II Randomized Study of Oral Valganciclovir Versus Valacyclovir for Prophylaxis of Cytomegalovirus Reactivation in Patients Receiving Alemtuzumab (Campath).|
|Brief Summary||To determine if the rate of cytomegalovirus reactivation during treatment with alemtuzumab (Campath) is reduced by the use of valganciclovir prophylaxis.|
Researchers will study the effectiveness of valganciclovir to help prevent cytomegalovirus infections in patients receiving alemtuzumab. Since alemtuzumab eliminates T-cells, which are the body's usual defense against viruses, patients taking alemtuzumab have an increased risk of developing CMV.
Before treatment, you will have a physical exam. You will also have around 3-4 tablespoons of blood drawn for routine tests and for tests to see if you have ever been exposed to CMV.
You will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will be given treatment with valganciclovir. Participants in the other group will be given treatment with valacyclovir. This drug protects against herpes infections but not CMV.
If you are assigned to the group that will receive valganciclovir, you will take valganciclovir by mouth once a day starting of your first day of alemtuzumab therapy. You will continue to take valganciclovir for 2 months after the end of alemtuzumab therapy.
If you are assigned to the group that will receive valacyclovir, you will take valacyclovir by mouth once a day starting of your first day of alemtuzumab therapy. You will continue to take valacyclovir for 2 months after the end of alemtuzumab therapy.
Every 2 weeks while you are receiving alemtuzumab (usually 4-12 weeks)you will have a repeat blood test to look for CMV.
Your participation in this study will last for a maximum of 5 months.
This is an investigational study. Both valganciclovir and valacyclovir are FDA approved and commercially available. However, the use of valganciclovir for this study is experimental. valganciclovir will be provided free of charge during the study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Publications *||O'Brien S, Ravandi F, Riehl T, Wierda W, Huang X, Tarrand J, O'Neal B, Kantarjian H, Keating M. Valganciclovir prevents cytomegalovirus reactivation in patients receiving alemtuzumab-based therapy. Blood. 2008 Feb 15;111(4):1816-9. Epub 2007 Nov 26.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||July 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||16 Years and older (Child, Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00562770|
|Other Study ID Numbers ICMJE||ID02-666|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||M.D. Anderson Cancer Center|
|Study Sponsor ICMJE||M.D. Anderson Cancer Center|
|Collaborators ICMJE||Roche Pharma AG|
|PRS Account||M.D. Anderson Cancer Center|
|Verification Date||July 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP