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The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cidofovir
Probenecid
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

13 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral agents. Oral trimethoprim/sulfamethoxazole. Aerosolized pentamidine. Dapsone. Fluconazole. Rifabutin. Filgrastim (G-CSF). p24 vaccine. Patients must have: Diagnosis of AIDS by CDC criteria. Diagnosis of peripheral (not immediately sight-threatening) CMV retinitis. Visual acuity in the affected eye of >= three lines on the ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 1 m distance. Life expectancy of at least 3 months. Consent of parent or guardian in patients less than 18 years of age. Prior Medication: Allowed: Acyclovir. Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin if given solely as prophylaxis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Media opacity that precludes visualization of the fundus of both eyes. Retinal detachment. Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. Active medical problems considered sufficient to hinder study compliance. Known clinically significant allergy to probenecid. Concurrent Medication: Excluded: Acyclovir (may be reinstituted following development of herpetic lesions). Ganciclovir. Foscarnet. Amphotericin B. Diuretics. Aminoglycoside antibiotics. CMV hyperimmune immunoglobulin. Intravenous pentamidine. Other nephrotoxic agents. Other investigational drugs with potential nephrotoxicity. Prior Medication: Excluded: Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin as therapy for CMV disease (although permitted if previously received solely as prophylaxis). Excluded within 1 week prior to study entry: Amphotericin B. Vidarabine. Other nephrotoxic agents. Aminoglycoside antibiotics. Intravenous pentamidine. Drug or alcohol abuse.

Sites / Locations

  • Los Angeles County - USC Med Ctr
  • UCI Med Ctr
  • Mount Zion Med Ctr
  • Beth Israel Hosp
  • Besselaar Associates
  • Univ of Rochester Med Ctr
  • Univ of North Carolina Hosps
  • Audie L Murphy Veterans Administration Hosp
  • Charing Cross and Westminster Med School

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00002437
Brief Title
The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
Official Title
A Phase II/III Study of the Safety and Efficacy of 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) for the Treatment of Peripheral Cytomegalovirus Retinitis in Patients With AIDS
Study Type
Interventional

2. Study Status

Record Verification Date
November 1994
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gilead Sciences

4. Oversight

5. Study Description

Brief Summary
To determine whether cidofovir (HPMPC) therapy administered by intravenous infusion can extend the time to progression of peripheral cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the safety and tolerance of HPMPC therapy when administered by intravenous infusion in AIDS patients with CMV retinitis that is not immediately sight-threatening. To evaluate the virologic effects of intravenous HPMPC therapy on CMV shedding in urine, blood, and/or semen. To evaluate the impact of HPMPC therapy on visual acuity.
Detailed Description
Patients are randomized to one of two treatment arms. Group A receives HPMPC by IV infusion weekly for 2 consecutive weeks (induction) and then every other week (maintenance) with oral probenecid and IV hydration. Group B receives no treatment until the time of retinitis progression (deferred treatment), at which time they receive the same regimen as Group A, provided retinitis progression is not immediately sight-threatening.

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, Probenecid, Drug Therapy, Combination, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents, cidofovir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
48 (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
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral agents. Oral trimethoprim/sulfamethoxazole. Aerosolized pentamidine. Dapsone. Fluconazole. Rifabutin. Filgrastim (G-CSF). p24 vaccine. Patients must have: Diagnosis of AIDS by CDC criteria. Diagnosis of peripheral (not immediately sight-threatening) CMV retinitis. Visual acuity in the affected eye of >= three lines on the ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 1 m distance. Life expectancy of at least 3 months. Consent of parent or guardian in patients less than 18 years of age. Prior Medication: Allowed: Acyclovir. Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin if given solely as prophylaxis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Media opacity that precludes visualization of the fundus of both eyes. Retinal detachment. Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. Active medical problems considered sufficient to hinder study compliance. Known clinically significant allergy to probenecid. Concurrent Medication: Excluded: Acyclovir (may be reinstituted following development of herpetic lesions). Ganciclovir. Foscarnet. Amphotericin B. Diuretics. Aminoglycoside antibiotics. CMV hyperimmune immunoglobulin. Intravenous pentamidine. Other nephrotoxic agents. Other investigational drugs with potential nephrotoxicity. Prior Medication: Excluded: Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin as therapy for CMV disease (although permitted if previously received solely as prophylaxis). Excluded within 1 week prior to study entry: Amphotericin B. Vidarabine. Other nephrotoxic agents. Aminoglycoside antibiotics. Intravenous pentamidine. Drug or alcohol abuse.
Facility Information:
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCI Med Ctr
City
Orange
State/Province
California
ZIP/Postal Code
92668
Country
United States
Facility Name
Mount Zion Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Beth Israel Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Besselaar Associates
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
085406681
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14607
Country
United States
Facility Name
Univ of North Carolina Hosps
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Audie L Murphy Veterans Administration Hosp
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Charing Cross and Westminster Med School
City
London SW 10
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
Lalezari J, et al. A phase II/III randomized study of immediate versus deferred intravenous (IV) cidofovir (CDV, HPMPC) for the treatment of peripheral CMV retinitis (CMV-R) in patients with AIDS. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:170
Results Reference
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The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

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