Search / Trial NCT00000905

A Study to Evaluate the Effects of Stopping Maintenance Therapy for Cytomegalovirus (CMV) Retinitis After Effective Anti-HIV Therapy

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

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Trial Information

Current as of June 13, 2024

Completed

Keywords

Immunity, Cellular Disease Progression Cytomegalovirus Retinitis Dna, Viral Prognosis

Description

This study proposes to assess the hypothesis that, in HIV-infected patients with treated and healed CMV retinitis, an increase in CD4+ T-cells after initiation of potent antiretroviral therapy is either directly related to, or a marker of, immunologic protection for CMV retinitis and is associated with a recovery in specific proliferation responses to CMV antigens. In this study, 100 patients [AS PER AMENDMENT 7/2/99: 50 patients] with treated and healed, non-immediate sight-threatening CMV retinitis will discontinue maintenance therapy for suppression of CMV retinitis. Patients are studie...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • You may be eligible for this study if you:
  • Are HIV-positive.
  • Have a CD4 count greater than 100 cells/mm3.
  • Have healed CMV retinitis after receiving anti-CMV therapy for at least 8 weeks within 3 months prior to study entry.
  • Have taken antiretroviral therapy for at least 8 weeks prior to study entry; combination therapy must include at least 2 of the following: protease inhibitors (PIs), nucleoside reverse transcriptase inhibitors (NRTIs), or non-nucleoside reverse transcriptase inhibitors (NNRTIs).
  • Have a life expectancy of at least 6 months.
  • Are at least 13 years old (need consent if under 18).
  • Exclusion Criteria
  • You will not be eligible for this study if you:
  • Have any unstable or severe medical conditions that would keep you from completing the study.
  • Require chemotherapy or radiation therapy.
  • Have a history of certain eye disorders.

Attachments

readout_NCT00000905_2024-06-13.pdf

4.5 MB

NCT00000905_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

Los Angeles, California, United States

Indianapolis, Indiana, United States

New York, New York, United States

New York, New York, United States

West Columbia, South Carolina, United States

San Francisco, California, United States

Chicago, Illinois, United States

San Diego, California, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

San Jose, California, United States

Stanford, California, United States

Stanford, California, United States

Baltimore, Maryland, United States

Buffalo, New York, United States

Cincinnati, Ohio, United States

Philadelphia, Pennsylvania, United States

Galveston, Texas, United States

Los Angeles, California, United States

San Francisco, California, United States

Denver, Colorado, United States

St Louis, Missouri, United States

Indianapolis, Indiana, United States

Menlo Park, California, United States

New York, New York, 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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1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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