HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol
- Conditions
- Cytomegalovirus RetinitisHIV Infections
- Registration Number
- NCT00000799
- Brief Summary
To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.
- Detailed Description
In Stage 1, up to 30 patients are randomized to either observation with deferral of treatment until the retinitis progresses (observation group), or to intravenous HPMPC at the higher dose for two consecutive weekly induction doses, followed by the lower dose every other week for maintenance. In Stage 2, up to 70 patients are randomized to observation or to HPMPC at the higher dose for two consecutive weekly induction doses followed by either dose every other week for maintenance, for a total of three treatment groups. Concomitant saline hydration and probenecid are administered to patients receiving HPMPC.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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 (7)
Johns Hopkins Hosp / SOCA
🇺🇸Baltimore, Maryland, United States
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
New York Univ Med Ctr / SOCA
🇺🇸New York, New York, United States
Northwestern Univ / SOCA
🇺🇸Chicago, Illinois, United States
Univ of North Carolina / SOCA
🇺🇸Chapel Hill, North Carolina, United States