Cytomegalovirus Retinitis, HIV Infections
Conditions
Keywords
Retinitis, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents, cidofovir
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.
Interventions
DRUGCidofovir
DRUGProbenecid
Sponsors
Gilead Sciences
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed