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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002070 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Cytomegalovirus Retinitis HIV Infections
Intervention ^ICMJE	Drug: Sargramostim Drug: Ganciclovir
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002070
Responsible Party
Study ID Numbers ^ICMJE	005A, C88-059
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	May 1991
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP