Phase II Randomized Study of Cidofovir for Peripheral Cytomegalovirus Retinitis
|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: NCT00004794|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
|First Submitted Date ICMJE||February 24, 2000|
|First Posted Date ICMJE||February 25, 2000|
|Last Update Posted Date||June 24, 2005|
|Study Start Date ICMJE||March 1995|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Phase II Randomized Study of Cidofovir for Peripheral Cytomegalovirus Retinitis|
|Official Title ICMJE||Not Provided|
OBJECTIVES: I. Evaluate the safety and efficacy of intravenous cidofovir in patients with small peripheral cytomegalovirus retinitis.
II. Obtain safety and efficacy data related to different dosages of cidofovir.
PROTOCOL OUTLINE: This is a randomized study. Cidofovir is administered intravenously. Treatment ideally begins within 24 hours of randomization.
In the first group, therapy is deferred until disease progression. Patients are then treated according to best medical judgement, which includes the option of cidofovir therapy.
The second group receives induction with cidofovir every 7 days for 2 weeks, then begins maintenance with a low dose given every 14 days until dose-limiting toxicity or disease progression occurs.
The third group receives the same cidofovir induction followed by a high maintenance dose given every 14 days until dose-limiting toxicity or disease progression occurs.
Probenecid and intravenous hydration are administered concurrently with cidofovir.
Patients are followed for progression and survival every 2 weeks for 23 weeks, then every 12 weeks. At disease progression, patients may be re-treated with another course of induction and maintenance.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Drug: cidofovir|
|Study Arms ICMJE||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PROTOCOL ENTRY CRITERIA:
No probenecid allergy No medical problems sufficient to hinder compliance with therapy or follow- up, including drug or alcohol abuse No pregnant or nursing women Negative serum pregnancy test required of fertile women Adequate birth control required of fertile patients during and for 3 months after study
|Ages ICMJE||13 Years to 60 Years (Child, Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT00004794|
|Other Study ID Numbers ICMJE||199/11927
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Center for Research Resources (NCRR)|
|Collaborators ICMJE||Northwestern University|
|PRS Account||Office of Rare Diseases (ORD)|
|Verification Date||January 1998|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP