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

NCT ID: NCT00002070

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Cytomegalovirus Retinitis HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Sargramostim

Intervention Type DRUG

Ganciclovir

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schering-Plough

INDUSTRY

Sponsor Role lead

Locations

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USC School of Medicine / Norris Cancer Hosp

Los Angeles, California, United States

Site Status

UCLA CARE Ctr

Los Angeles, California, United States

Site Status

Children's Hosp of San Francisco

San Francisco, California, United States

Site Status

Pacific Presbyterian

San Francisco, California, United States

Site Status

Gottlieb Med Group

Sherman Oaks, California, United States

Site Status

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Site Status

Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll

Chicago, Illinois, United States

Site Status

Cabrini Med Ctr

New York, New York, United States

Site Status

Dr Douglas Dieterich

New York, New York, United States

Site Status

Saint Luke's - Roosevelt Hosp Ctr

New York, New York, United States

Site Status

Univ of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, United States

Site Status

Methodist Hosp

Houston, Texas, United States

Site Status

Infectious Disease Physicians Inc

Annandale, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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C88-059

Identifier Type: -

Identifier Source: secondary_id

005A

Identifier Type: -

Identifier Source: org_study_id