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

Schering-Plough

Status and phase: Completed; Phase 3

Conditions: Cytomegalovirus Retinitis; HIV Infections

Treatments: Drug: Ganciclovir; Drug: Sargramostim

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002070

005A

C88-059

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.