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

Trial Information

Current as of December 08, 2024

Completed

Keywords

Immunity, Cellular Disease Progression Cytomegalovirus Retinitis Dna, Viral Prognosis

ClinConnect Summary

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 stud...

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.

Trial Officials

Torriani F

Study Chair

Wohl D

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

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

Discussion 0

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