Studies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT)

NCT00000142 | Completed Phase 2 Results DMC

• 1 other identifier: NEI-41
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

To test and evaluate the efficacy and safety of intravenous cidofovir (Vistide, previously known as HPMPC) for the treatment of retinitis.

Conditions

HIV Infections; CMV Cytomegalovirus Retinitis

Outcome Measures

Primary Outcomes (1)

• Survival

  All patients enrolled will be followed until a common study closing date

Study Arms (3)

treatment deferral

EXPERIMENTAL

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

Cidofovir (low dose)

EXPERIMENTAL

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

Cidofovir (high dose)

EXPERIMENTAL

5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.

Drug: Cidofovir

Interventions

Cidofovir DRUG

Three groups: 1. the deferral group, treatment deferred until retinitis progressed 2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks. 3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.

Also known as: Vistide

Cidofovir (high dose); Cidofovir (low dose); treatment deferral

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of AIDS according to the Centers for Disease Control and Prevention (CDC)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Baylor College of Medicine: collaborator
• Johns Hopkins University: collaborator
• Louisiana State University Health Sciences Center in New Orleans: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• New Jersey Medical School: collaborator
• NYU Langone Health: collaborator
• Northwestern University: collaborator
• University of California, Los Angeles: collaborator
• University of California, San Diego: collaborator
• University of California, San Francisco: collaborator
• University of Miami: collaborator
• University of North Carolina, Chapel Hill: collaborator
• University of South Florida: collaborator

Related Publications (4)

• 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.

  PMID: 9036798 BACKGROUND

• Long-term follow-up of patients with AIDS treated with parenteral cidofovir for cytomegalovirus retinitis: the HPMPC Peripheral Cytomegalovirus Retinitis Trial. The Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group. AIDS. 2000 Jul 28;14(11):1571-81.

  PMID: 10983644 BACKGROUND

• Kravcik S. Cidofovir for cytomegalovirus retinitis. Ann Intern Med. 1997 Sep 15;127(6):490-1. doi: 10.7326/0003-4819-127-6-199709150-00015. No abstract available.

  PMID: 9313009 BACKGROUND

• Holland GN, Van Natta ML, Goldenberg DT, Ritts R Jr, Danis RP, Jabs DA; Studies of Ocular Complications of AIDS Research Group. Relationship Between Opacity of Cytomegalovirus Retinitis Lesion Borders and Severity of Immunodeficiency Among People With AIDS. Invest Ophthalmol Vis Sci. 2019 May 1;60(6):1853-1862. doi: 10.1167/iovs.18-26517.

  PMID: 31042791 DERIVED

MeSH Terms

Conditions

HIV Infections; Cytomegalovirus Retinitis

Interventions

Cidofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Eye Infections, Viral; Eye Infections; Cytomegalovirus Infections; Herpesviridae Infections; DNA Virus Infections; Eye Diseases; Retinitis; Retinal Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Cytosine; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Curtis Meinert
• Organization: Johns Hopkins Bloomberg School of Public Health

cmeinert@jhsph.edu

410-955-8175

Study Officials

• Douglas Jabs, MD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 1999
• First Posted: September 24, 1999
• Study Start: April 1, 1994
• Primary Completion: February 1, 1996
• Study Completion: February 1, 1996
• Last Updated: November 17, 2015
• Results First Posted: November 17, 2015

Record last verified: 2015-07