Search / Trial NCT00001034

The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of November 14, 2024

Completed

Keywords

Retinitis Ganciclovir Cytomegalovirus Infections Administration, Oral Acquired Immunodeficiency Syndrome Gastrointestinal System

ClinConnect Summary

The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis.

Patients are randomized in a 2:1 ratio to receive either oral ganciclovir or placebo for a minimum of 12 months. PER AMENDMENT 9/19/94: Patients who have not reached a study endpoint may choose to continue blinded prophylaxis or discontinue blinded prophylaxis and begin open-label ganciclovir. PER AMENDME...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Antiretroviral therapy.
  • Anti-PCP prophylaxis.
  • Maintenance or prophylaxis therapy for other opportunistic infections besides CMV.
  • Patients must have:
  • Working diagnosis of HIV infection.
  • CD4 count \<= 100 cells/mm3.
  • Positive CMV serology (IgG) or CMV culture, in the absence of active disease, documented at any time prior to study entry.
  • Reasonably good health.
  • Life expectancy of at least 6 months.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Acute life-threatening illness.
  • Active lymphoma.
  • Hypersensitivity to acyclovir.
  • Lack of willingness or ability, in the opinion of the clinician, to comply with protocol requirements.
  • Concurrent Medication:
  • Excluded:
  • Vidarabine.
  • Amantadine hydrochloride (Symmetrel).
  • CMV hyperimmune globulin/intravenous immune globulin.
  • Cytarabine.
  • Fiacitabine (FIAC) or fialuridine (FIAU).
  • Foscarnet.
  • Intravenous ganciclovir.
  • HPMPC.
  • Idoxuridine.
  • Intravenous acyclovir.
  • Oral acyclovir at \> 1 g/day.
  • Other drugs with potential anti-CMV activity.
  • Prior Medication:
  • Excluded within 60 days prior to study entry:
  • Foscarnet.
  • Excluded within 2 weeks prior to study entry:
  • Vidarabine.
  • Amantadine hydrochloride (Symmetrel).
  • CMV hyperimmune globulin/intravenous immune globulin.
  • Cytarabine.
  • Fiacitabine (FIAC) or fialuridine (FIAU).
  • Ganciclovir.
  • HPMPC.
  • Idoxuridine.
  • Intravenous acyclovir.
  • Oral acyclovir at \> 1 g/day.
  • Other drugs with potential anti-CMV activity.

Trial Officials

Brosgart C

Study Chair

Craig C

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Denver, Colorado, United States

Wilmington, Delaware, United States

Washington, District Of Columbia, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

New Orleans, Louisiana, United States

Detroit, Michigan, United States

Detroit, Michigan, United States

Newark, New Jersey, United States

Bronx, New York, United States

Brooklyn, New York, United States

New York, New York, United States

New York, New York, United States

Richmond, Virginia, United States

San Francisco, California, United States

Portland, Oregon, United States

Kenilworth, New Jersey, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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