Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
- Conditions
- Cytomegalovirus RetinitisHIV Infections
- Registration Number
- NCT00002070
- Lead Sponsor
- Schering-Plough
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
USC School of Medicine / Norris Cancer Hosp
🇺🇸Los Angeles, California, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
Children's Hosp of San Francisco
🇺🇸San Francisco, California, United States
Pacific Presbyterian
🇺🇸San Francisco, California, United States
Gottlieb Med Group
🇺🇸Sherman Oaks, California, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
🇺🇸Chicago, Illinois, United States
Cabrini Med Ctr
🇺🇸New York, New York, United States
Dr Douglas Dieterich
🇺🇸New York, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
Scroll for more (4 remaining)USC School of Medicine / Norris Cancer Hosp🇺🇸Los Angeles, California, United States