A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
Although SMX/TMP remains the drug of choice for PCP prophylaxis, drug sensitivity may limit its use. Atovaquone has demonstrated greater safety than SMX/TMP and thus is suitable as a candidate drug for treatment and prophylaxis of PCP. Azithromycin, with a broad anti-microbial spectrum (including mycoplasma and atypical mycoplasma), is an attractive prophylactic agent for use in children with HIV infection, due to its relative safety and once-daily dosing regimen. Therefore, the combination of atovaquone and azithromycin may offer broader antimicrobial coverage and greater safety than SMX/T...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Children may be eligible for this study if they:
- • Are HIV-positive.
- • Are between the age of 3 months and 18 months (consent of parent or guardian required). (This study has been changed. In an earlier version, patients up to 19 years old were eligible.)
- • Are at risk for developing pneumonia and need preventive treatment.
- • Have a CD4 count of less than 1,500 cells/mm3 if under 1 year of age or a CD4 count of less then 500 cells/mm3 if between 1 and 2 years of age.
- • Exclusion Criteria
- Children will not be eligible for this study if they:
- • Have an infection that requires treatment.
- • Are allergic to atovaquone, azithromycin, or SMX/TMP.
- • Have serious diarrhea for more than 1 week.
Trial Officials
Wayne M Dankner
Study Chair
Ram Yogev
Study Chair
Walter T Hughes
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.
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
Bronx, New York, United States
La Jolla, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, 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
Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Baltimore, Maryland, 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
Albany, New York, United States
Brooklyn, New York, United States
Buffalo, 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
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Stony Brook, New York, United States
Syracuse, New York, United States
Durham, North Carolina, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Houston, Texas, United States
Houston, Texas, 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
Augusta, Georgia, United States
Farmington, Connecticut, United States
New Orleans, Louisiana, United States
Worcester, Massachusetts, United States
Jacksonville, Florida, United States
Rochester, New York, United States
Birmingham, Alabama, United States
Mobile, Alabama, United States
Farmington, Connecticut, United States
Fort Lauderdale, Florida, United States
Gainesville, Florida, United States
Riviera Beach, Florida, United States
New Orleans, Louisiana, United States
Jackson, Mississippi, United States
Camden, New Jersey, United States
Nashville, Tennessee, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
Related articles
Similar Trials