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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002095
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1993
  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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
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: NCT00002095

Locations
United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
Kraus - Beer Med Group
Los Angeles, California, United States, 90028
UCSD
San Diego, California, United States, 92103
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States, 94121
Mount Zion Med Ctr
San Francisco, California, United States, 94115
Davies Med Ctr / c/o HIV Institute
San Francisco, California, United States, 94114
Harbor - UCLA Med Ctr
Torrance, California, United States, 90502
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
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
Univ of Pittsburgh / Graduate School of Public Health
Pittsburgh, Pennsylvania, United States, 15261
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:
ClinicalTrials.gov Identifier: NCT00002095     History of Changes
Other Study ID Numbers: 059D, ICM 1654
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:
Ganciclovir
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
Cytomegalovirus Infections
HIV Infections
Immunologic Deficiency Syndromes
Infection
DNA Virus Infections
Herpesviridae Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Ganciclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014