Overview

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

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Ganciclovir
Ganciclovir triphosphate
Interferon beta-1b
Interferon-beta
Interferons

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.