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A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus

This study has been completed.

Sponsored by: Hoffmann-La Roche
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002095
  Purpose

To evaluate the efficacy of oral ganciclovir in preventing progression to cytomegalovirus (CMV) disease (e.g., CMV retinitis, gastrointestinal CMV disease) in CMV-infected people with HIV infection and CD4 lymphocyte counts <= 100 cells/mm3. To evaluate the efficacy of this drug in reducing morbidity associated with coinfection by both CMV and HIV.


Condition Intervention
Cytomegalovirus Infections
HIV Infections
Drug: Ganciclovir

MedlinePlus related topics:   AIDS    Cytomegalovirus Infections   

Drug Information available for:   Ganciclovir    Ganciclovir sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Safety Study
Official Title:   A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus

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

Estimated Enrollment:   700

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Topical or ophthalmic nucleoside analogs.

Patients must have:

  • Confirmation of HIV infection.
  • Documented CMV infection.
  • No past or present CMV disease (e.g., retinitis, colitis, esophagitis).
  • Adequate visualization of the retina of both eyes by ophthalmologist.
  • CD4 count <= 50 cells/mm3 (in patients WITHOUT a history of an AIDS-defining opportunistic infection or chronic gynecologic infection) OR CD4 count <= 100 cells/mm3 (in patients WITH a history of an AIDS-defining opportunistic infection or chronic gynecologic infection).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Presence of gastrointestinal disease or symptoms not controlled with medications (e.g., persistent nausea, abdominal pain or persistent diarrhea within the past 4 weeks that is not controllable with medication).
  • Inability to comply with protocol.

Concurrent Medication:

Excluded:

  • The following nucleoside analogs:
  • IV ganciclovir, IV acyclovir for more than 2 weeks total duration, oral acyclovir at doses > 1000 mg/day, vidarabine, amantadine hydrochloride, cytarabine, idoxuridine.
  • FIAU, FIAC, foscarnet, CMV hyperimmune globulin, IV immune globulin, CMV monoclonal antibody, HPMPC.
  • Imipenem-cilastatin (Primaxin).

Patients with the following prior condition are excluded:

History of hypersensitivity to acyclovir.

Prior Medication:

Excluded within the past 60 days:

Ganciclovir, foscarnet, FIAC, FIAU, CMV hyperimmune globulin, CMV monoclonal antibody, or HPMPC.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002095

Locations
United States, California
San Francisco Veterans Administration Med Ctr    
      San Francisco, California, United States, 94121
Davies Med Ctr / c/o HIV Institute    
      San Francisco, California, United States, 94114
East Bay AIDS Ctr    
      Berkeley, California, United States, 94705
Mount Zion Med Ctr    
      San Francisco, California, United States, 94115
UCSD    
      San Diego, California, United States, 92103
Harbor - UCLA Med Ctr    
      Torrance, California, United States, 90502
Kraus - Beer Med Group    
      Los Angeles, California, United States, 90028
United States, District of Columbia
Georgetown Univ Med Ctr    
      Washington, District of Columbia, United States, 20007
United States, Florida
Community Research Initiative    
      Coral Gables, Florida, United States, 33146
United States, Georgia
AIDS Research Consortium of Atlanta    
      Atlanta, Georgia, United States, 30308
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll    
      Chicago, Illinois, United States, 60612
United States, Massachusetts
Beth Israel Hosp    
      Boston, Massachusetts, United States, 02215
United States, New York
Kaplan Cancer Ctr / New York Univ Med Ctr    
      New York, New York, United States, 10016
St Lukes - Roosevelt Hosp Ctr    
      New York, New York, United States, 10019
Cornell Univ Med College / New York Hosp    
      New York, New York, United States, 10021
United States, Pennsylvania
Univ of Pittsburgh / Graduate School of Public Health    
      Pittsburgh, Pennsylvania, United States, 15261
Buckley Braffman Stern Med Associates    
      Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Oak Lawn Physicians Group    
      Dallas, Texas, United States, 75219
Infectious Diseases Association of Houston    
      Houston, Texas, United States, 77030

Sponsors and Collaborators
Hoffmann-La Roche
  More Information


Publications:

Study ID Numbers:   059D, ICM 1654
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002095
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Ganciclovir  
Cytomegalovirus Infections  
Acquired Immunodeficiency Syndrome  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Ganciclovir
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Cytomegalovirus Infections
DNA Virus Infections
Retroviridae Infections
Cytomegalic inclusion disease

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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