Completed

CMV Retinitis Retreatment Trial

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What is being tested

Foscarnet sodium

+ Ganciclovir
Drug
Who is being recruted

Cytomegalovirus Retinitis

+ HIV Infections
Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: March 1, 2011
Sourced from a government-validated database.Claim as a partner

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.

Official TitleCMV Retinitis Retreatment Trial 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: March 1, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
300 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cytomegalovirus Retinitis
HIV Infections
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 9 locations
Suspended
UCSD - Shiley Eye Ctr / SOCALa Jolla, United StatesSee the location
Suspended
UCLA - Jules Stein Eye Institute / SOCALos Angeles, United States
Suspended
UCSF - San Francisco Gen HospSan Francisco, United States
Suspended
Northwestern Univ / SOCAChicago, United States

Completed9 Study Centers