Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis

June 23, 2005 updated by: Schering-Plough
To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute neutrophil count less than 500 cells/mm3. To assess if improved tolerance of ganciclovir is associated with a favorable outcome as defined by a delayed time to progression of retinitis; to confirm the safety and co-administration of ganciclovir and GM-CSF; to assess the changes in the expression of HIV p24 antigen in the serum and number of T4+ lymphocytes in the blood of patients receiving ganciclovir with or without GM-CSF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

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
    • California
      • Los Angeles, California, United States, 90095
        • UCLA CARE Ctr
      • Los Angeles, California, United States, 90033
        • USC School of Medicine / Norris Cancer Hosp
      • San Francisco, California, United States, 94118
        • Children's Hosp of San Francisco
      • San Francisco, California, United States, 94118
        • Pacific Presbyterian
      • Sherman Oaks, California, United States, 91403
        • Gottlieb Med Group
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
    • New York
      • New York, New York, United States, 10025
        • Saint Luke's - Roosevelt Hosp Ctr
      • New York, New York, United States, 10016
        • Dr Douglas Dieterich
      • New York, New York, United States, 10003
        • Cabrini Med Ctr
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ of Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75235
        • Univ of Texas Southwestern Med Ctr of Dallas
      • Houston, Texas, United States, 77030
        • Methodist Hosp
    • Virginia
      • Annandale, Virginia, United States, 22203
        • Infectious Disease Physicians Inc

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patient must have the following:

  • AIDS as defined by CDC criteria.
  • Retinitis as diagnosed by the study ophthalmologist.
  • Performance status 0, 1, or 2.
  • Ability to give informed consent and suitability of intravenous access for scheduled blood tests.
  • Patient may have Kaposi's sarcoma or basal skin cancer.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Active acute infection requiring treatment.
  • Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.
  • Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.

Patients with the following are excluded:

  • Active acute infection requiring treatment.
  • Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.
  • Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.

Prior Medication:

Excluded:

  • Granulocyte macrophage colony-stimulating factor (GM-CSF).
  • Colony stimulating factor.
  • Interleukin 3.
  • Excluded within 7 days of study entry:
  • Zidovudine (AZT).
  • Trimethoprim / sulfamethoxazole (TMP / SMX).
  • Pyrimethamine.
  • Excluded within 30 days of study entry:
  • Biologic response modifiers.
  • Cytotoxic agents.
  • Investigational agents.

Prior Treatment:

Excluded:

  • Radiation therapy.

Required within 1 week of study entry:

  • One or more doses of ganciclovir.

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

Schering-Plough

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

May 1, 1991

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005A
  • C88-059

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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