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CMV Retinitis Retreatment Trial
This study has been completed.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000766
  Purpose

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.


Condition Intervention Phase
Cytomegalovirus Retinitis
HIV Infections
Drug: Foscarnet sodium
Drug: Ganciclovir
Phase II

MedlinePlus related topics: AIDS Cytomegalovirus Infections
Drug Information available for: Ganciclovir Ganciclovir sodium Foscarnet Foscarnet sodium Fosfonet sodium Phosphonoacetic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Safety Study
Official Title: CMV Retinitis Retreatment Trial

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 300
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000766

Locations
United States, California
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94143
UCSD - Shiley Eye Ctr / SOCA
La Jolla, California, United States, 920930946
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, California, United States, 900957003
United States, Illinois
Northwestern Univ / SOCA
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Hosp / SOCA
Baltimore, Maryland, United States, 212879217
United States, New York
New York Hosp - Cornell Med Ctr / Sloan - Kettering / SOCA
New York, New York, United States, 10021
Mount Sinai Med Ctr / SOCA
New York, New York, United States, 100296574
New York Univ Med Ctr / SOCA
New York, New York, United States, 10016
United States, North Carolina
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, United States, 275997030
Sponsors and Collaborators
  More Information

Click here for more information about Ganciclovir  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: ACTG 228
Study First Received: November 2, 1999
Last Updated: August 25, 2008
ClinicalTrials.gov Identifier: NCT00000766  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Retinitis
Ganciclovir
Foscarnet
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:
Phosphonoacetic Acid
Sexually Transmitted Diseases, Viral
Eye Diseases
Eye Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Retinitis
Ganciclovir
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections
Cytomegalovirus retinitis
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Cytomegalovirus Infections
DNA Virus Infections
Foscarnet
Cytomegalic inclusion disease
Retroviridae Infections
Retinal Diseases

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Eye Infections, Viral
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009