Studies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT) (HPCRT)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00000142 |
Recruitment Status :
Completed
First Posted : September 24, 1999
Results First Posted : November 17, 2015
Last Update Posted : November 17, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections CMV Cytomegalovirus Retinitis | Drug: Cidofovir | Phase 2 Phase 3 |
CMV (cytomegalovirus) retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 percent to 40 percent of patients with AIDS. Untreated CMV (cytomegalovirus) retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. As of September 1997, drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV (cytomegalovirus)retinitis were ganciclovir (Cytovene), foscarnet (Foscavir), and cidofovir (Vistide). Cidofovir has a prolonged duration of effect permitting intermittent administration. All systemically administered anti-CMV drugs are given in a similar fashion consisting of initial 2-week high-dose treatment (induction) to control the infection followed by long-term lower dose treatment (maintenance) to prevent relapse. Cidofovir is administered as an intravenous infusion once weekly for induction therapy and once every 2 weeks as maintenance therapy. The HPCRT evaluated the efficacy and safety of cidofovir therapy.
The HPCRT was a multicenter, randomized, controlled clinical trial of cidofovir for the treatment of CMV (cytomegalovirus) retinitis. Patients with small peripheral CMV (cytomegalovirus) retinitis lesions (i.e., not at risk of immediate loss of visual acuity) were randomized to immediate treatment with cidofovir or deferred therapy until the retinitis had progressed. Patients randomized to immediate therapy received either 1) low-dose cidofovir at 5 mg/kg once weekly induction for 2 weeks, followed by 3 mg/kg once every 2 weeks for maintenance or 2) high-dose cidofovir at 5 mg/kg once weekly induction for 2 weeks followed by 5 mg/kg once every 2 weeks for maintenance. Patients whose retinitis progressed were given treatment according to best medical judgement, and those assigned to deferral were generally treated with cidofovir.
Outcomes in this trial included retinitis progression, loss of retinal area, and morbidity.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Studies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT) |
Study Start Date : | April 1994 |
Actual Primary Completion Date : | February 1996 |
Actual Study Completion Date : | February 1996 |

Arm | Intervention/treatment |
---|---|
Experimental: treatment deferral
IV (in the vein) treatment deferred until retinitis progressed, either: 5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or 5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks. |
Drug: Cidofovir
Three groups:
Other Name: Vistide |
Experimental: Cidofovir (low dose)
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks
|
Drug: Cidofovir
Three groups:
Other Name: Vistide |
Experimental: Cidofovir (high dose)
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
Drug: Cidofovir
Three groups:
Other Name: Vistide |
- Survival [ Time Frame: All patients enrolled will be followed until a common study closing date ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- diagnosis of AIDS according to the Centers for Disease Control and Prevention (CDC)
- 13 years or older
- Diagnosis of CMV (cytomegalovirus) retinitis as determined by a SOCA-certified Ophthalmologist.
- At least one lesion whose size is one-quarter disc area or more that can be photographed.
- Visual acuity in an affected eye of 3 or more lines on the (ETDRS) Early Treatment Diabetic Retinopathy Study chart at 1 meter distance (Snellen equivalent 8/200).
- score of 60 or more on the Karnofsky scale.
- Serum creatinine of 1.5mg/dL or less
- less than 1+ proteinuria on urinalysis
- Total bilirubin of 3.0 mg/dL or less
- Hepatic transaminase levels that do not exceed 5 times the normal levels
- Absolute neutrophil count of 750 cells/µL or greater
- Platelet count of 50,000 cells/µL or greater
- Hemoglobin of 7.5 g/dL or greater
- Negative pregnancy test (females of childbearing potential)
- All men/women of childbearing potential should practice birth control to prevent pregnancy while on study and for 3 months afterwards
- Willingness/ability, with the assistance of a caregiver if necessary to comply with treatment and follow-up procedures
- Signed consent statement
Exclusion criteria:
- Evidence of a CMV (cytomegalovirus) retinitis lesion within zone 1. A lesion less than 1,500 µ from the margin of the optic disc or less than 3,000 µ from the center of the fovea in either eye excludes a patient.
- Evidence of a CMV retinitis lesions that involves 25% or more of the retinal area regardless of location.
- Previous or ongoing therapy for CMV (cytomegalovirus) disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents solely as prophylaxis are eligible for enrollment.
- Retinal detachment(s) in the affected eye(s)
- media opacity that precludes visualization of the fundus of both eyes.
- patients with a diagnosis of extraocular CMV (cytomegalovirus) disease.
- Patients with history of clinically significant renal disease or renal dialysis.
- Patients with history of clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- pregnant or lactating
- patients with active medical problems including drug or alcohol abuse which could hinder compliance with treatment or follow-up procedures.
- patients receiving therapy within the previous 7 days with nephrotoxic drugs, including: Amphotericin B, Vidarabine, Aminoglycoside antibiotics, Intravenous pentamidine. Patients receiving any of these drugs must discontinue the drug(s) at least one week prior to the time of enrollment, and for the duration of the trial period.
- history of clinically significant probenecid allergy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000142
Study Chair: | Douglas Jabs, MD | Icahn School of Medicine at Mount Sinai |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT00000142 |
Other Study ID Numbers: |
NEI-41 |
First Posted: | September 24, 1999 Key Record Dates |
Results First Posted: | November 17, 2015 |
Last Update Posted: | November 17, 2015 |
Last Verified: | July 2015 |
Cytomegalovirus Retinitis Retinitis Virus Diseases Retinal Diseases Eye Diseases Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections |
Eye Infections, Viral Eye Infections Cidofovir Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |