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HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cidofovir
Probenecid
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Retinitis, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents, cidofovir

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSD - Shiley Eye Ctr / SOCA
  • UCLA - Jules Stein Eye Institute / SOCA
  • UCSF - San Francisco Gen Hosp
  • Northwestern Univ / SOCA
  • Johns Hopkins Hosp / SOCA
  • New York Univ Med Ctr / SOCA
  • Univ of North Carolina / SOCA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 31, 2012
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00000799
Brief Title
HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol
Official Title
HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 1996 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Gilead Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
Keywords
Retinitis, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents, cidofovir

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cidofovir
Intervention Type
Drug
Intervention Name(s)
Probenecid

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
UCSD - Shiley Eye Ctr / SOCA
City
La Jolla
State/Province
California
ZIP/Postal Code
920930946
Country
United States
Facility Name
UCLA - Jules Stein Eye Institute / SOCA
City
Los Angeles
State/Province
California
ZIP/Postal Code
900957003
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Northwestern Univ / SOCA
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins Hosp / SOCA
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212879217
Country
United States
Facility Name
New York Univ Med Ctr / SOCA
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Univ of North Carolina / SOCA
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9036798
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.
Results Reference
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HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

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