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 June 23, 2025
Completed
Keywords
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.
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.
Contacts
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
Patients applied
Trial Officials
Torriani F
Study Chair
Wohl D
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials