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

November 2, 1999
February 28, 2011
Not Provided
September 1995   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00000766 on ClinicalTrials.gov Archive Site
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CMV Retinitis Retreatment Trial
CMV Retinitis Retreatment Trial

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
  • Drug: Foscarnet sodium
  • Drug: Ganciclovir
Not Provided
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.
 
Completed
300
Not Provided
September 1995   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000766
ACTG 228
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
February 2011

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