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

NCT ID: NCT00002299

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

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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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Interferon beta-1b

Intervention Type DRUG

Ganciclovir

Intervention Type DRUG

Eligibility Criteria

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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:
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Locations

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USC

Los Angeles, California, United States

Site Status

UCI Med Ctr

Orange, California, United States

Site Status

Univ of California / San Diego Treatment Ctr

San Diego, California, United States

Site Status

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, California, United States

Site Status

Stanford Univ School of Medicine

Stanford, California, United States

Site Status

Univ TX Galveston Med Branch

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ICM 1285

Identifier Type: -

Identifier Source: secondary_id

017A

Identifier Type: -

Identifier Source: org_study_id