Search / Trial NCT00000688

A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

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

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Retinitis Injections, Intravenous Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome

Description

CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG. Patients are randomly placed in one of two treatment groups. In one group, patients receive DHPG twice a day, intravenously, for 14 days, followed by a daily dose for 14 weeks. Patients in the other group (the delayed-treatment group) do not receive immediate treatment with DHPG. Patients in both groups have regular oph...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Zidovudine (AZT) for patients in delayed treatment group and not receiving ganciclovir.
  • Didanosine (ddI) may be continued or initiated in any patient during the study.
  • Topical acyclovir.
  • Topical ophthalmics.
  • Aerosolized pentamidine.
  • Patients must have:
  • AIDS as defined by the CDC criteria or have had confirmation of HIV infection by ELISA, p24 antigen assay, or culture of HIV.
  • Retinal lesions greater than 1500 microns from edge of optic disc outside major temporal vascular arcades, and greater than 3000 microns from fovea.
  • Understanding of study provisions, and willingness to sign informed consent form approved by the appropriate Institutional Review Board and Syntex.
  • Life expectancy of at least 4 months.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with ocular conditions requiring immediate surgical correction are excluded.
  • Concurrent Medication:
  • Excluded during first 4 weeks of ganciclovir treatment:
  • Zidovudine (AZT).
  • Excluded:
  • Other investigational drugs and antimetabolites, alkylating agents, nucleoside analogs (topical ophthalmics are permitted), acyclovir, interferon, foscarnet (non-nucleoside pyrophosphate analog), cytomegalovirus (CMV) hyperimmune globulin, and cytokines.
  • Patients with the following are excluded:
  • Immediately sight-threatening retinitis (= or < 1500 microns from edge of optic disc, or inside major temporal vascular arcades, or = or < 3000 microns from the fovea).
  • Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic and photographic retinal assessment.
  • Demonstrated hypersensitivity to acyclovir.
  • Prior Medication:
  • Excluded:
  • - Previous treatment with anti-cytomegalovirus therapy.

Attachments

readout_NCT00000688_2024-05-23.pdf

4.5 MB

NCT00000688_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

Indianapolis, Indiana, United States

New York, New York, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Detroit, Michigan, United States

San Diego, California, United States

San Francisco, California, United States

Houston, Texas, United States

Minneapolis, Minnesota, United States

Stanford, California, United States

San Francisco, California, United States

Washington, District Of Columbia, United States

Cincinnati, Ohio, United States

Galveston, Texas, United States

San Francisco, California, United States

San Mateo, California, United States

Kansas City, Missouri, United States

St Louis, Missouri, United States

Albuquerque, New Mexico, United States

New York, New York, United States

Houston, Texas, United States

Annandale, Virginia, 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
41
4 stars
6
3 stars
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2 stars
0
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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