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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:
Information provided by:
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

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

Resource links provided by NLM:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Retinitis
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Retinal Diseases
Eye Diseases
 Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Interferon-beta
Ganciclovir
Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013