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

Completed · Not applicable

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002299

Run by

Hoffmann-La Roche

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Co-existing Condition:
• Patients not meeting inclusion criteria are excluded.
• Patients not meeting inclusion criteria are excluded.

Where it is running

• 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
• Stanford Univ School of Medicine — Stanford, California, United States
• Univ TX Galveston Med Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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