799
Last Update Posted: 2012-11-01
Recruiting has ended
All Genders accepted | 13 Years + |
100 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol
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.
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.
Eligibility
Relevant conditions:
Cytomegalovirus Retinitis
HIV Infections
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
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Contact Information
Overall Contact
No valid contacts available
Data sourced from ClinicalTrials.gov