Clinical trial NCT00000799: HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol
Official title: HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: Retinitis
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Antiviral Agents
cidofovir
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Gilead Sciences
First posted: 2001-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD - Shiley Eye Ctr / SOCA
state: California
city: Los Angeles
country: United States
facility: UCLA - Jules Stein Eye Institute / SOCA
state: California
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: Chicago
country: United States
facility: Northwestern Univ / SOCA
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hosp / SOCA
state: Maryland
city: New York
country: United States
facility: New York Univ Med Ctr / SOCA
state: New York
city: Chapel Hill
country: United States
facility: Univ of North Carolina / SOCA
state: North Carolina
Study officials:
References:
citation: Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: the HPMPC peripheral cytomegalovirus retinitis trial. A randomized, controlled trial. Studies of Ocular complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Ann Intern Med. 1997 Feb 15;126(4):264-74. doi: 10.7326/0003-4819-126-4-199702150-00002.