A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS Who Have Not Had Success With Ganciclovir

June 23, 2005 updated by: Astra USA

Foscarnet Treatment of Cytomegalovirus (CMV) Retinitis in AIDS Patients Not Eligible for Ganciclovir Therapy and Ganciclovir Treatment Failures

To evaluate the safety and efficacy of foscarnet induction treatment of cytomegalovirus (CMV) retinitis in AIDS patients who have previously suffered severe dose-limiting ganciclovir-related myelosuppression, who are ineligible for ganciclovir treatment due to myelosuppression or who have clearly failed to have a therapeutic response to ganciclovir therapy. To assess the duration of clinical response. To evaluate the effect on quantitative CMV cultures of blood and urine. To determine the effect on recovery of HIV p24 antigen capture direct from plasma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

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
    • Texas
      • Houston, Texas, United States, 77004
        • Foscarnet Research Program / Park Plaza Hosp

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Ganciclovir.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Known allergy to foscarnet.
  • Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
  • Corneal, lens, or vitreous opacification which precludes examination of the fundi in patients with cytomegalovirus (CMV) retinitis.

Concurrent Medication:

Excluded:

  • Acyclovir.
  • Nephrotoxic agent.

Patients with the following are excluded:

  • Known allergy to foscarnet.
  • Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
  • Corneal, lens, or vitreous opacification which precludes examination of the fundi in patients with CMV retinitis.

Prior Medication:

Excluded within 7 days of study entry:

  • Immunomodulators.
  • Biologic response modifiers.
  • Investigational agents.

AIDS patients experiencing cytomegalovirus (CMV) retinitis may be enrolled if they meet one of the following criteria:

  • Myelosuppression:
  • Previously suffered severe dose-limiting ganciclovir-related myelosuppression, or are ineligible for ganciclovir treatment due to myelosuppression.
  • Ganciclovir treatment failure:
  • Clearly failed to have a therapeutic response to ganciclovir therapy.
  • Patients must be able to give informed consent.
  • Patients presenting with a baseline absolute neutrophil count < 750 cells/mm3 or baseline platelet count < 50000 platelets/mm3 will be categorized as ineligible to receive ganciclovir induction therapy and will be allowed to enter the study.

  • Patients who enter the study because of ganciclovir toxicity will have received ganciclovir therapy which resulted in either absolute neutrophil count falling to < 750 cells/mm3 or platelet count falling to < 50000 platelets/mm3 on two separate occasions during either

    1) a ganciclovir induction regimen of 7.5 mg or less ganciclovir/kg/day in divided doses or 2) a maintenance regimen of 5 mg or less ganciclovir/kg/day as a single dose.

  • Patients who enter the study because of ganciclovir treatment failure will meet one of the following criteria:

  • 1) CMV retinitis progression as defined in section V.C.1., i.e., has occurred either at the end of a 10 - 21 day induction course of ganciclovir (7.5 - 10.0 mg/kg/day in divided doses) or 2) during the first 28 days of maintenance ganciclovir therapy (5 or more mg/kg/day in at least 5 days/week) where maintenance therapy began within

    1. week of completing induction therapy.

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

Collaborators and Investigators

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

Sponsor

Astra USA

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

  • Ussery FM, Karol C, Conklin R, Gathe J, Stool E, Redding K. Preliminary results from an on-going prospective evaluation of foscarnet in the treatment of AIDS-associated cytomegalovirus retinitis. Int Conf AIDS. 1989 Jun 4-9;5:551 (abstract no MCP60)

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

March 1, 1991

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020B
  • 88-FOS-02

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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