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A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cytomegalovirus Retinitis; HIV Infections

Intervention: Zidovudine (Drug); Ganciclovir (Drug)

Phase: N/A

Status: Completed

Sponsored by: Hoffmann-La Roche

Summary

To evaluate the safety and tolerance of long-term ganciclovir (DHPG) therapy for newly diagnosed macular threatening Cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the clinical response to a 52 week course of intravenous DHPG therapy. To evaluate the safety and tolerance of long-term DHPG with concurrent treatment with zidovudine (AZT). (Patients utilizing treatment with other anti-retroviral drugs will be considered for study entry on a case by case basis.) To determine survival in this group of patients with AIDS and CMV retinitis.

Clinical Details

Official title: A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS

Study design: Endpoint Classification: Safety Study, Primary Purpose: Treatment

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria Concurrent Medication: Allowed:

- Topical acyclovir.

- Selected cytokines.

- Allowed after the first 4 weeks of ganciclovir:

- Zidovudine (AZT) at a reduced dose (500 mg/day) in patients who have tolerated

ganciclovir without grade 3/4 hematological toxicity.

- Other anti-retrovirals after consultation with the Syntex study monitor.

Patients must have the following:

- AIDS and newly diagnosed Cytomegalovirus (CMV) retinitis.

- An understanding of the nature of the study, agreement to its provisions, and

willingness to sign the informed consent approved by the appropriate institutions review board, and Syntex. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded:

- Have only peripheral CMV retinitis (defined as a lesion outside the major temporal

vascular arcades, greater than 1500 microns from the optic disk, or greater than 3000 microns from the fovea).

- Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic

retinal assessment.

- Ocular conditions requiring immediate surgical correction (eg:

- retinal tear or detachment).

- Demonstrated hypersensitivity to acyclovir or ganciclovir.

- Dementia, decreased mentation or other encephalopathic signs and symptoms which would

interfere with the ability of the patient to comply with the protocol. Concurrent Medication: Excluded:

- Antimetabolites.

- Alkylating agents.

- Nucleoside analogs (excluding selected anti-retroviral agents).

- Imipenem-cilastatin.

- Interferons.

- Selected cytokines.

- Acyclovir (except topical acyclovir).

Patients with the following are excluded:

- Have only peripheral CMV retinitis (defined as a lesion outside the major temporal

vascular arcades, greater than 1500 microns from the optic disk or greater than 3000 microns from the fovea).

- Concomitant conditions or diseases described in Exclusion Co-Existing Conditions.

Prior Medication: Excluded within 1 month of study entry:

- Previous treatment with anti-cytomegalovirus therapy (e. g., ganciclovir, foscarnet or

CMV hyperimmune globulin).

Locations and Contacts

Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States

Southern Alberta HIV Clinic / Foothills Hosp, Calgary, Alberta, Canada

Summitt Med Ctr / San Francisco Gen Hosp, Oakland, California 94609, United States

Stanford at Kaiser / Kaiser Permanente Med Ctr, San Francisco, California 94115, United States

Miami Veterans Administration Med Ctr, Miami, Florida 33125, United States

Dr Winkler Weinberg, Roswell, Georgia 30076, United States

SUNY / Health Sciences Ctr at Stony Brook, Stony Brook, New York 117948153, United States

Dr Alfred F Burnside Jr, Columbia, South Carolina 29204, United States

Univ TX Galveston Med Branch, Galveston, Texas 77550, United States

Additional Information


Last updated: June 23, 2005

Page last updated: August 20, 2015

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