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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cytomegalovirus Retinitis, HIV Infections

Intervention / Treatment
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* Drug: Sargramostim
* Drug: Ganciclovir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sargramostim|nan|
|Drug: Ganciclovir|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recombinant Proteins, Retinitis, AIDS-Related Opportunistic Infections, Neutropenia, Ganciclovir, Drug Therapy, Combination, Granulocyte-Macrophage Colony-Stimulating Factor, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome