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CMV Retinitis Retreatment Trial

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: NCT00000766
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : March 1, 2011
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE November 2, 1999
First Posted Date  ICMJE August 31, 2001
Last Update Posted Date March 1, 2011
Study Start Date  ICMJE Not Provided
Actual Primary Completion Date September 1995   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00000766 on ClinicalTrials.gov Archive Site
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
 
Descriptive Information
Brief Title  ICMJE CMV Retinitis Retreatment Trial
Official Title  ICMJE CMV Retinitis Retreatment Trial
Brief Summary

To assess the safety and efficacy of three therapeutic regimens (foscarnet, ganciclovir, or the combination) for recurrent or persistent AIDS-related cytomegalovirus (CMV) retinitis.

Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs.

Detailed Description

Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs.

Patients are randomized to receive foscarnet, ganciclovir, or a combination of the two drugs (administered sequentially). Initially, patients undergo single or multiple cycles of induction therapy for 14 days followed by maintenance therapy. Patients in whom the retinitis continues to progress or who are intolerant of the initial treatment switch to the alternative drug for further cycles of induction and maintenance. Patients on the combination arm in whom retinitis continues to progress are given further cycles of the combination at an increased dose, or, if one drug is causing toxicity, are given further cycles with the alternative drug. Patients are followed monthly for 6 months and then every 3 months thereafter.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Cytomegalovirus Retinitis
  • HIV Infections
Intervention  ICMJE
  • Drug: Foscarnet sodium
  • Drug: Ganciclovir
Study Arms  ICMJE Not Provided
Publications * Jabs DA. Design of clinical trials for drug combinations: cytomegalovirus retinitis--foscarnet and ganciclovir. The CMV retinitis retreatment trial. Antiviral Res. 1996 Jan;29(1):69-71.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
300
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 1995   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

Required:

  • At least 28 days of prior foscarnet or ganciclovir.

Concurrent Medication:

Allowed:

  • G-CSF.

Recommended:

  • Antiretroviral therapy.

Patients must have:

  • HIV infection or AIDS.
  • Active CMV retinitis after 28 or more days of either foscarnet or ganciclovir therapy.
  • At least one lesion with one-quarter disk area or more that can be photographed.
  • Visual acuity of 3 or more letters on ETDRS chart (5/200 Snellen) in an affected eye.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Media opacity severe enough to preclude visualization of both fundi.
  • Retinal detachment not scheduled for surgical repair.

Patients with the following prior conditions are excluded:

  • History of intolerance to ganciclovir or foscarnet sufficient to contraindicate use.
  • History of combination foscarnet/ganciclovir therapy.

Active drug or alcohol abuse sufficient to prevent compliance.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000766
Other Study ID Numbers  ICMJE ACTG 228
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 Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP