Clinical trial NCT00002070: Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
Official title: Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: Recombinant Proteins
Retinitis
AIDS-Related Opportunistic Infections
Neutropenia
Ganciclovir
Drug Therapy, Combination
Granulocyte-Macrophage Colony-Stimulating Factor
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC School of Medicine / Norris Cancer Hosp
state: California
city: Los Angeles
country: United States
facility: UCLA CARE Ctr
state: California
city: San Francisco
country: United States
facility: Children's Hosp of San Francisco
state: California
city: San Francisco
country: United States
facility: Pacific Presbyterian
state: California
city: Sherman Oaks
country: United States
facility: Gottlieb Med Group
state: California
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
state: Illinois
city: New York
country: United States
facility: Cabrini Med Ctr
state: New York
city: New York
country: United States
facility: Dr Douglas Dieterich
state: New York
city: New York
country: United States
facility: Saint Luke's - Roosevelt Hosp Ctr
state: New York
city: Philadelphia
country: United States
facility: Univ of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Houston
country: United States
facility: Methodist Hosp
state: Texas
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
Study officials:
References: