Oral Valganciclovir Versus Valacyclovir

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00562770
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Valganciclovir — DRUG
    900 mg (two 450 mg capsules) po QD during therapy and for 2 months post alemtuzumab initiation.
  • Valacyclovir — DRUG
    500 mg po QD during therapy and for 2 months post alemtuzumab initiation.

Study Details

To determine if the rate of cytomegalovirus reactivation during treatment with alemtuzumab (Campath) is reduced by the use of valganciclovir prophylaxis.

Key Dates

Start date
Sep 30, 2003
Status verified
Jul 2012
Completion
Jul 31, 2006

Study Design

Enrollment
46 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    Valacyclovir
  • Active Comparator: 2
    Valganciclovir

Primary Outcome Measure

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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-

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The University of Texas M.D. Anderson Cancer Center· Houston, TX

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