Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Schering-Plough
Treatments:
Ganciclovir
Ganciclovir triphosphate
Sargramostim
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.