CMV Retinitis Retreatment Trial

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000766
First received: November 2, 1999
Last updated: February 28, 2011
Last verified: February 2011
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: CMV Retinitis Retreatment Trial

Resource links provided by NLM:


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

Estimated Enrollment: 300
Primary Completion Date: September 1995 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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 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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00000766     History of Changes
Other Study ID Numbers: ACTG 228
Study First Received: November 2, 1999
Last Updated: February 28, 2011
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Retinitis
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Foscarnet
Phosphonoacetic Acid
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014