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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002070
• Other study ID #: 005A
• Secondary ID: C88-059
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: May 1991
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Sargramostim

• Ganciclovir

Locations

Country	Name	City	State
United States	Infectious Disease Physicians Inc	Annandale	Virginia
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll	Chicago	Illinois
United States	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Methodist Hosp	Houston	Texas
United States	UCLA CARE Ctr	Los Angeles	California
United States	USC School of Medicine / Norris Cancer Hosp	Los Angeles	California
United States	Cabrini Med Ctr	New York	New York
United States	Dr Douglas Dieterich	New York	New York
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York
United States	Univ of Pennsylvania	Philadelphia	Pennsylvania
United States	Children's Hosp of San Francisco	San Francisco	California
United States	Pacific Presbyterian	San Francisco	California
United States	Gottlieb Med Group	Sherman Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Schering-Plough

Country where clinical trial is conducted

United States,