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| Descriptive Information Fields | |
| Brief Title † | Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis |
| Official Title † | Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis |
| 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 | |
| Study Phase | Phase III |
| Study Type † | Interventional |
| Study Design † | Treatment |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Cytomegalovirus Retinitis HIV Infections |
| Intervention † | Drug: Sargramostim Drug: Ganciclovir |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | Inclusion Criteria Patient must have the following:
Exclusion Criteria Co-existing Condition: Patients with the following are excluded:
Patients with the following are excluded:
Prior Medication: Excluded:
Prior Treatment: Excluded:
Required within 1 week of study entry:
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00002070 |
| Organization ID | 005A |
| Secondary IDs †† | C88-059 |
| Study Sponsor † | Schering-Plough |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | May 1991 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 23, 2005 |