The Safety and Effectiveness of Ganciclovir Plus Interferon Beta in Preventing the Return of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytomegalovirus Retinitis; HIV Infections
Intervention: Interferon beta-1b (Drug); Ganciclovir (Drug)
Phase: N/A
Status: Completed
Sponsored by: Hoffmann-La Roche
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.
Clinical Details
Official title: Combination Therapy With 9-(1,3-Dihydroxy-2-Propoxymethyl) Guanine (DHPG) and Interferon Beta for the Prevention of Relapse of Cytomegalovirus Retinitis in Patients With the Acquired Immunodeficiency Syndrome
Study design: Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Univ of California / San Diego Treatment Ctr, San Diego, California 921036325, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr, San Francisco, California 94115, United States
USC, Los Angeles, California 90033, United States
UCI Med Ctr, Orange, California 92668, United States
Stanford Univ School of Medicine, Stanford, California 94305, United States
Univ TX Galveston Med Branch, Galveston, Texas 77550, United States
Additional Information
Last updated: June 23, 2005
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