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

Not Applicable

Completed

• Conditions: Cytomegalovirus Retinitis; HIV Infections

• Registration Number: NCT00002299
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

Not available

Study Timeline

• Status Verified: 1990-04
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

UCI Med Ctr; 🇺🇸 Orange, California, United States

Univ of California / San Diego Treatment Ctr; 🇺🇸 San Diego, California, United States

USC; 🇺🇸 Los Angeles, California, United States

Stanford Univ School of Medicine; 🇺🇸 Stanford, California, United States

Stanford at Kaiser / Kaiser Permanente Med Ctr; 🇺🇸 San Francisco, California, United States

Univ TX Galveston Med Branch; 🇺🇸 Galveston, Texas, United States