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

Purpose

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.

Condition	Intervention	Phase
Cytomegalovirus Retinitis HIV Infections	Drug: Sargramostim Drug: Ganciclovir	Phase III

MedlinePlus related topics:

AIDS Cytomegalovirus Infections

ChemIDplus related topics:

Ganciclovir Ganciclovir sodium Sargramostim Granulocyte-macrophage colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002070

Locations


United States, California
	UCLA CARE Ctr
	Los Angeles, California, United States, 90095
	Children's Hosp of San Francisco
	San Francisco, California, United States, 94118
	USC School of Medicine / Norris Cancer Hosp
	Los Angeles, California, United States, 90033
	Gottlieb Med Group
	Sherman Oaks, California, United States, 91403
	Pacific Presbyterian
	San Francisco, California, United States, 94118

United States, Georgia
	AIDS Research Consortium of Atlanta
	Atlanta, Georgia, United States, 30308

United States, Illinois
	Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
	Chicago, Illinois, United States, 60612

United States, New York
	Saint Luke's - Roosevelt Hosp Ctr
	New York, New York, United States, 10025
	Cabrini Med Ctr
	New York, New York, United States, 10003
	Dr Douglas Dieterich
	New York, New York, United States, 10016

United States, Pennsylvania
	Univ of Pennsylvania
	Philadelphia, Pennsylvania, United States, 19104

United States, Texas
	Univ of Texas Southwestern Med Ctr of Dallas
	Dallas, Texas, United States, 75235
	Methodist Hosp
	Houston, Texas, United States, 77030

United States, Virginia
	Infectious Disease Physicians Inc
	Annandale, Virginia, United States, 22203

Sponsors and Collaborators

Schering-Plough

More Information

Study ID Numbers:	005A, C88-059
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002070
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Recombinant Proteins

Retinitis

AIDS-Related Opportunistic Infections

Neutropenia

Ganciclovir

Drug Therapy, Combination

Granulocyte-Macrophage Colony-Stimulating Factor

Cytomegalovirus Infections

Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:

Opportunistic Infections

Sexually Transmitted Diseases, Viral

Eye Diseases

Eye Infections

Acquired Immunodeficiency Syndrome

Cytomegalovirus Retinitis

Retinitis

Ganciclovir

Cytomegalovirus

Immunologic Deficiency Syndromes

Herpesviridae Infections

Cytomegalovirus retinitis

Virus Diseases

Neutropenia

HIV Infections

AIDS-Related Opportunistic Infections

Sexually Transmitted Diseases

Cytomegalovirus Infections

DNA Virus Infections

Cytomegalic inclusion disease

Retroviridae Infections

Retinal Diseases

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Slow Virus Diseases

Eye Infections, Viral

Immune System Diseases

Therapeutic Uses

Lentivirus Infections

Infection

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	Schering-Plough
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002070