HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol
Cidofovir
+ Probenecid
Blood-Borne Infections+22
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria Concurrent Medication: Allowed: Oral trimethoprim/sulfamethoxazole. Aerosolized pentamidine. Dapsone. Fluconazole. Ketoconazole. Itraconazole. Rifabutin. Filgrastim (G-CSF). Antiretroviral agents. Patients must have: AIDS by CDC criteria. CMV retinitis as determined by a SOCA-certified ophthalmologist, with lesion size, location, and severity as specified in the Disease Status field. Prior Medication: Allowed: Prophylaxis with anti-CMV agents. Exclusion Criteria Concurrent Medication: Excluded: Ongoing therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity. Therapy with nephrotoxic drugs, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine. Patients with the following prior conditions are excluded: History of renal disease or renal dialysis. History of clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. History of clinically significant probenecid allergy. Prior Medication: Excluded: Prior therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity. Therapy with nephrotoxic drugs within the past 7 days, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine. Drug or alcohol abuse sufficient to hinder compliance with study.
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 7 locations
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, United StatesUCSF - San Francisco Gen Hosp
San Francisco, United StatesNorthwestern Univ / SOCA
Chicago, United States