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

June 23, 2005 updated by: Gilead Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 085406681
        • Besselaar Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

October 1, 1995

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 216B
  • GS-93-107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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