The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
- Conditions
- Cytomegalovirus RetinitisHIV Infections
- Registration Number
- NCT00002437
- Lead Sponsor
- Gilead Sciences
- Brief Summary
To determine whether cidofovir (HPMPC) therapy administered by intravenous infusion can extend the time to progression of peripheral cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the safety and tolerance of HPMPC therapy when administered by intravenous infusion in AIDS patients with CMV retinitis that is not immediately sight-threatening. To evaluate the virologic effects of intravenous HPMPC therapy on CMV shedding in urine, blood, and/or semen. To evaluate the impact of HPMPC therapy on visual acuity.
- Detailed Description
Patients are randomized to one of two treatment arms. Group A receives HPMPC by IV infusion weekly for 2 consecutive weeks (induction) and then every other week (maintenance) with oral probenecid and IV hydration. Group B receives no treatment until the time of retinitis progression (deferred treatment), at which time they receive the same regimen as Group A, provided retinitis progression is not immediately sight-threatening.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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)
Charing Cross and Westminster Med School
🇬🇧London SW 10, United Kingdom
Mount Zion Med Ctr
🇺🇸San Francisco, California, United States
Univ of North Carolina Hosps
🇺🇸Chapel Hill, North Carolina, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Audie L Murphy Veterans Administration Hosp
🇺🇸San Antonio, Texas, United States
UCI Med Ctr
🇺🇸Orange, California, United States
Besselaar Associates
🇺🇸Princeton, New Jersey, United States
Beth Israel Hosp
🇺🇸Boston, Massachusetts, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States