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

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.

Completed

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Key information

Conditions

Cytomegalovirus Retinitis AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome Agranulocytosis Amino Acid Metabolism, Inborn Errors Blood-Borne Infections Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cytomegalovirus Infections Cytopenia DNA Virus Infections Eye Diseases Eye Infections Eye Infections, Viral Genetic Diseases, Inborn Genital Diseases HIV Infections Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Leukocyte Disorders Leukopenia Metabolic Diseases Metabolism, Inborn Errors Mitochondrial Diseases Multiple Acyl Coenzyme A Dehydrogenase Deficiency Neutropenia Nutritional and Metabolic Diseases Opportunistic Infections RNA Virus Infections Retinal Diseases Retinitis Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UCLA CARE Ctr, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sargramostim

Drug

Ganciclovir

Drug

Sponsors and collaborators

Lead sponsor

Schering-Plough

Industry

Registry information

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed