CMV Retinitis Retreatment Trial

Completed · Phase 2

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000766

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

300

Last updated by the study team

2011-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCSD - Shiley Eye Ctr / SOCA — La Jolla, California, United States
• UCLA - Jules Stein Eye Institute / SOCA — Los Angeles, California, United States
• UCSF - San Francisco Gen Hosp — San Francisco, California, United States
• Northwestern Univ / SOCA — Chicago, Illinois, United States
• Johns Hopkins Hosp / SOCA — Baltimore, Maryland, United States
• New York Univ Med Ctr / SOCA — New York, New York, United States
• New York Hosp - Cornell Med Ctr / Sloan - Kettering / SOCA — New York, New York, United States
• Mount Sinai Med Ctr / SOCA — New York, New York, United States
• Univ of North Carolina / SOCA — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.