Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
2 other identifiers
interventional
N/A
1 country
14
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.
Trial Health
Trial Health Score
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14 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
May 1, 1991
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Schering-Ploughlead
Study Sites (14)
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, 90033, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Children's Hosp of San Francisco
San Francisco, California, 94118, United States
Pacific Presbyterian
San Francisco, California, 94118, United States
Gottlieb Med Group
Sherman Oaks, California, 91403, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
Chicago, Illinois, 60612, United States
Cabrini Med Ctr
New York, New York, 10003, United States
Dr Douglas Dieterich
New York, New York, 10016, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235, United States
Methodist Hosp
Houston, Texas, 77030, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1991-05