Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Hoffmann-La Roche


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002299

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1990
History of Changes
Purpose

Purpose

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.

Condition Intervention
Cytomegalovirus Retinitis
HIV Infections

Drug : Interferon beta-1b
Drug : Ganciclovir

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 60 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002299

Locations

United States, California
USC
Los Angeles, California, United States, 90033
UCI Med Ctr
Orange, California, United States, 92668
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
Stanford Univ School of Medicine
Stanford, California, United States, 94305
United States, Texas
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550

Sponsors and Collaborators

Hoffmann-La Roche
More Information

More Information


Responsible Party: Hoffmann-La Roche  
ClinicalTrials.gov Identifier: NCT00002299   History of Changes  
Other Study ID Numbers: 017A  
  ICM 1285  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Retinitis
AIDS-Related Opportunistic Infections
Ganciclovir
Drug Therapy, Combination
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Interferon Type I

Additional relevant MeSH terms:
Infection
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Retinitis
Interferons
Interferon-beta
Ganciclovir
Interferon beta-1b
Ganciclovir triphosphate

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.