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

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Trial Information

Current as of March 05, 2024

Completed

Keywords

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

Description

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.

Attachments

readout_NCT00001034_2024-03-05.pdf

4.5 MB

NCT00001034_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

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

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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4 stars
6
3 stars
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1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

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Leslie Alexander
20 September 2023

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