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

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sargramostim
Ganciclovir
Sponsored by
Schering-Plough
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Recombinant Proteins, Retinitis, AIDS-Related Opportunistic Infections, Neutropenia, Ganciclovir, Drug Therapy, Combination, Granulocyte-Macrophage Colony-Stimulating Factor, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USC School of Medicine / Norris Cancer Hosp
  • UCLA CARE Ctr
  • Children's Hosp of San Francisco
  • Pacific Presbyterian
  • Gottlieb Med Group
  • AIDS Research Consortium of Atlanta
  • Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
  • Cabrini Med Ctr
  • Dr Douglas Dieterich
  • Saint Luke's - Roosevelt Hosp Ctr
  • Univ of Pennsylvania
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Methodist Hosp
  • Infectious Disease Physicians Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00002070
Brief Title
Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
Official Title
Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 1991
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
Schering-Plough

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
Keywords
Recombinant Proteins, Retinitis, AIDS-Related Opportunistic Infections, Neutropenia, Ganciclovir, Drug Therapy, Combination, Granulocyte-Macrophage Colony-Stimulating Factor, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sargramostim
Intervention Type
Drug
Intervention Name(s)
Ganciclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
USC School of Medicine / Norris Cancer Hosp
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Children's Hosp of San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Pacific Presbyterian
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Gottlieb Med Group
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Cabrini Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Dr Douglas Dieterich
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Univ of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Methodist Hosp
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States

12. IPD Sharing Statement

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

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