The Safety and Effectiveness of Ganciclovir Plus Interferon Beta in Preventing the Return of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Hoffmann-La Roche

Overview

The use of ganciclovir (DHPG) in combination with interferon beta to prevent relapse of cytomegalovirus retinitis in patients with AIDS. While early clinical trials have shown that 30 mg/kg/week of DHPG is usually sufficient to delay or prevent relapse, neutropenia is a common dose-limiting problem in about 50 percent of patients. Since in vitro data have suggested that there is synergism between DHPG and interferon beta against cytomegalovirus, a reduced dose of DHPG in combination with a low dose of interferon beta may prevent relapse without causing neutropenia. If remission can be maintained with low-dose DHPG and interferon beta, maintenance therapy with a moderate dose of interferon beta alone will be evaluated in a subsequent protocol.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Cytomegalovirus Retinitis HIV Infections

Interventions

Interferon beta-1bDRUG

GanciclovirDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria Patients must fulfill the CDC criteria for the diagnosis of AIDS. In addition, patients must have a typical clinical picture of cytomegalovirus (CMV) retinitis, a positive CMV culture from any site, and no other possible explanation for the retinal findings (e.g., toxoplasmosis infection). Patients with AIDS in whom CMV retinitis is suspected will be examined by an ophthalmologist and, if, retinal lesions are seen, shall have a complete set of retinal photographs taken. CMV cultures of throat, buffy coat, urine, and if possible, semen will be obtained. * Cytomegalovirus and toxoplasmosis serologic (IgG and IgM) tests will also be performed. Exclusion Criteria Co-existing Condition: Patients not meeting inclusion criteria are excluded. Patients not meeting inclusion criteria are excluded.

Locations (6)

USC

Los Angeles, California, United States

UCI Med Ctr

Orange, California, United States

Univ of California / San Diego Treatment Ctr

San Diego, California, United States

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, California, United States

Data from ClinicalTrials.gov

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