CMV Retinitis Retreatment Trial
- Conditions
- Cytomegalovirus RetinitisHIV Infections
- Registration Number
- NCT00000766
- 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 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.
- 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, 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Johns Hopkins Hosp / SOCA
🇺🇸Baltimore, Maryland, 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
Northwestern Univ / SOCA
🇺🇸Chicago, Illinois, United States
UCLA - Jules Stein Eye Institute / SOCA
🇺🇸Los Angeles, California, United States
New York Univ Med Ctr / SOCA
🇺🇸New York, New York, United States
UCSD - Shiley Eye Ctr / SOCA
🇺🇸La Jolla, California, United States
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States