Completed

CMV Retinitis Retreatment Trial

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
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
No eligibility criteria are available at this time.Please check with the study contact for more details. 
Anonymus Profile Image
Ensure optimum compatibilityAdd your profile to know your probability eligibility score.


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