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

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

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

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Ganciclovir Granulocyte-macrophage colony-stimulating factor Ganciclovir sodium Sargramostim

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	005A, C88-059
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002070 History of Changes
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

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Retinitis
Therapeutic Uses
Cytomegalovirus Infections
Retroviridae Infections
Retinal Diseases
RNA Virus Infections
Immune System Diseases
Eye Infections, Viral
Eye Diseases
Cytomegalovirus Retinitis

Acquired Immunodeficiency Syndrome
Eye Infections
Ganciclovir
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Herpesviridae Infections
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on March 18, 2010