Status:

COMPLETED

CMV Retinitis Retreatment Trial

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Cytomegalovirus Retinitis

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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...

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, deterioratin...

Eligibility 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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT00000766

Last Update

March 1 2011

Active Locations (9)

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Page 1 of 3 (9 locations)

1

UCSD - Shiley Eye Ctr / SOCA

La Jolla, California, United States, 920930946

2

UCLA - Jules Stein Eye Institute / SOCA

Los Angeles, California, United States, 900957003

3

UCSF - San Francisco Gen Hosp

San Francisco, California, United States, 94143

4

Northwestern Univ / SOCA

Chicago, Illinois, United States, 60611