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

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

This study has been completed.

Study NCT00002070. Last updated on June 23, 2005. Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by ^†

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
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†
Start Date ^†
Completion Date
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.
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

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.