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An Open-Label Study of the Safety and Efficacy of Cidofovir for the Treatment of Relapsing Cytomegalovirus Retinitis in Patients With AIDS

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
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 - undefined (Child, Adult, Older 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). Itraconazole. HIV vaccines. Patients must have: AIDS. CMV retinitis, with severity as specified in the Disease Status field. Life expectancy of at least 3 months. Consent of parent or guardian if less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known clinically significant allergy to probenecid. Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. Other active medical problems sufficient to hinder study compliance. Concurrent Medication: Excluded: Amphotericin B. Aminoglycoside antibiotics. Vidarabine. Intravenous pentamidine. CMV hyperimmune immunoglobulin. Other nephrotoxic or potentially nephrotoxic agents. Other investigational agents with anti-CMV activity. Ganciclovir. Intravenous or oral acyclovir (except following development of herpetic lesion). Foscarnet. Diuretics. Prior Medication: Excluded within 2 days prior to study entry: Ganciclovir or foscarnet. Excluded within one week prior to study entry: Amphotericin B. Aminoglycoside antibiotics. Vidarabine. Intravenous pentamidine. CMV hyperimmune immunoglobulin. Other nephrotoxic agents. Other investigational agents with anti-CMV activity. Excluded at any time: Prior systemic or intravitreal HPMPC. Drug or alcohol abuse that is considered sufficient to hinder study compliance.

Sites / Locations

  • Besselaar Associates

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
NCT00002142
Brief Title
An Open-Label Study of the Safety and Efficacy of Cidofovir for the Treatment of Relapsing Cytomegalovirus Retinitis in Patients With AIDS
Official Title
An Open-Label Study of the Safety and Efficacy of Cidofovir for the Treatment of Relapsing Cytomegalovirus Retinitis in Patients With AIDS
Study Type
Interventional

2. Study Status

Record Verification Date
October 1995
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 evaluate the safety and tolerance of cidofovir (HPMPC) infusions in AIDS patients with relapsing cytomegalovirus (CMV) retinitis. To determine the time to retinitis progression in this patient population. To evaluate the impact of cidofovir therapy on visual acuity.
Detailed Description
Patients are randomized to receive intravenous HPMPC either at one dose for both induction and maintenance or at a higher dose for induction than for maintenance. Induction consists of two consecutive weekly doses followed by maintenance every other week. All patients receive concomitant probenecid and saline hydration. Treatment continues until retinitis progression, as assessed by retinal photographs, or treatment-limiting toxicity occurs.

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
Not Applicable
Masking
None (Open Label)
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: Antiretroviral agents. Oral trimethoprim/sulfamethoxazole. Aerosolized pentamidine. Dapsone. Fluconazole. Rifabutin. Filgrastim (G-CSF). Itraconazole. HIV vaccines. Patients must have: AIDS. CMV retinitis, with severity as specified in the Disease Status field. Life expectancy of at least 3 months. Consent of parent or guardian if less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known clinically significant allergy to probenecid. Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. Other active medical problems sufficient to hinder study compliance. Concurrent Medication: Excluded: Amphotericin B. Aminoglycoside antibiotics. Vidarabine. Intravenous pentamidine. CMV hyperimmune immunoglobulin. Other nephrotoxic or potentially nephrotoxic agents. Other investigational agents with anti-CMV activity. Ganciclovir. Intravenous or oral acyclovir (except following development of herpetic lesion). Foscarnet. Diuretics. Prior Medication: Excluded within 2 days prior to study entry: Ganciclovir or foscarnet. Excluded within one week prior to study entry: Amphotericin B. Aminoglycoside antibiotics. Vidarabine. Intravenous pentamidine. CMV hyperimmune immunoglobulin. Other nephrotoxic agents. Other investigational agents with anti-CMV activity. Excluded at any time: Prior systemic or intravitreal HPMPC. Drug or alcohol abuse that is considered sufficient to hinder study compliance.
Facility Information:
Facility Name
Besselaar Associates
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
085406681
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Stagg RJ, et al. The Vistide (cidofovir injection) treatment IND for relapsing CMV retinitis (CMV-R). 4th Conf Retro and Opportun Infect. 1997 Jan 22-26;:120 (abstract no 306)
Results Reference
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An Open-Label Study of the Safety and Efficacy of Cidofovir for the Treatment of Relapsing Cytomegalovirus Retinitis in Patients With AIDS

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