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

Completed · Phase 3

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002070

Run by

Schering-Plough

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC School of Medicine / Norris Cancer Hosp — Los Angeles, California, United States
• UCLA CARE Ctr — Los Angeles, California, 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, 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
• 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
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Methodist Hosp — Houston, Texas, United States
• Infectious Disease Physicians Inc — Annandale, Virginia, United States

Full record on ClinicalTrials.gov

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