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CMV Retinitis Retreatment Trial

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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)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cytomegalovirus Retinitis HIV Infections Drug: Foscarnet sodium Drug: Ganciclovir Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Primary Purpose: Treatment
Official Title: CMV Retinitis Retreatment Trial
Actual Primary Completion Date : September 1995

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000766


Locations
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United States, California
UCSD - Shiley Eye Ctr / SOCA
La Jolla, California, United States, 920930946
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, California, United States, 900957003
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94143
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 Univ Med Ctr / SOCA
New York, New York, United States, 10016
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
United States, North Carolina
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, United States, 275997030
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00000766    
Other Study ID Numbers: ACTG 228
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: March 1, 2011
Last Verified: February 2011
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Retinitis
Ganciclovir
Foscarnet
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
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Cytomegalovirus Retinitis
Retinitis
Infections
Virus Diseases
Retinal Diseases
Eye Diseases
Eye Infections, Viral
Eye Infections
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
 Ganciclovir
Ganciclovir triphosphate
Foscarnet
Phosphonoacetic Acid
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors