A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of June 22, 2025
Completed
Keywords
ClinConnect Summary
Due to the strong correlation between a significant decrease in CD4 count and the frequency and magnitude of OIs such as Pneumocystis carinii pneumonia (PCP), Mycobacterium avium complex (MAC), and severe bacterial infections, CD4 count has become the major criterion for initiating antimicrobial prophylaxis for OIs. However, despite the benefits of these antimicrobial drugs, all are associated with adverse side effects, and patients with reconstituted immune systems following antiretroviral therapy may be receiving prophylaxis unnecessarily. Benefits to stopping prophylaxis include: (1) eli...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Children may be eligible for this study if they:
- • Are HIV-positive.
- • Have a CD4 percent greater than or equal to 25 percent if they are under 6 years of age, or have a CD4 percent greater than or equal to 20 percent on 2 occasions if they are between the ages of 6 and 21.
- • Have been receiving preventive treatment for PCP for at least 6 months and have not stopped treatment for more than 3 months before study entry.
- • Are willing to stop taking preventive treatment for PCP and MAC.
- • Have received the same continuous antiretroviral (anti-HIV) therapy for the 16 weeks before beginning the study. (Continuous therapy means missing no more than a total of 3 weeks during the 16 weeks.)
- • Are between the ages of 2 and 21 years (consent of parent or guardian is required if under 18).
- • Exclusion Criteria
- Children will not be eligible for this study if they:
- • Have PCP.
- • Have any other active infection, such as tuberculosis or toxoplasmosis, or any other significant disease.
- • Are receiving chemotherapy for cancer or certain other medications.
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
Springfield, Massachusetts, United States
Seattle, Washington, United States
La Jolla, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Oakland, California, United States
San Francisco, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Washington, District Of Columbia, United States
Washington, District Of Columbia, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
New Brunswick, New Jersey, United States
Newark, New Jersey, United States
Brooklyn, New York, United States
Great Neck, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Stony Brook, New York, United States
Durham, North Carolina, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Bayamon, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Newark, New Jersey, United States
Bronx, New York, United States
Los Angeles, California, United States
New Orleans, Louisiana, United States
Worcester, Massachusetts, United States
Jacksonville, Florida, United States
Rochester, New York, United States
Birmingham, Alabama, United States
Riviera Beach, Florida, United States
Jackson, Mississippi, United States
Richmond, Virginia, United States
Phoenix, Arizona, United States
Patients applied
Trial Officials
Wayne Dankner
Study Chair
Ram Yogev
Study Chair
Walter Hughes
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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