A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients Between Ages 4 and 22 With 7 Drugs, Some at Higher Than Usual Doses
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
Clinicians are increasingly confronted with HIV-positive children who have failed all available antiretroviral therapies and have few viable treatment options. Virologic failure in these patients may be a result of antiretroviral resistance, likely a result of poor adherence to the treatment regimen or inadequate dosing. This study is designed to achieve adherence through observation of drug administration for the first 8 weeks of the study and to further overcome resistance by intensive, high-dose, multi-drug therapy. Treatment with more than 4 drugs has not been studied formally in childr...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Patients may be eligible for this trial if they:
- • Are HIV-positive.
- • Have HIV levels of 10,000 copies/ml or more.
- • Are between ages 4 and 22.
- • Have motivation and ability to conform to the complex treatment regimen.
- • Agree to practice abstinence or use 2 effective methods of birth control during the study and until 3 months after stopping the study drugs, if sexually active.
- • Have written informed consent from a parent or legal guardian if under age 18.
- • Have used at least 3 different nucleoside reverse transcriptase inhibitors (NRTIs) for at least 3 months each or have shown resistance to at least 3 different NRTIs.
- • Have used at least 1 nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 3 months each or have shown resistance.
- • Have used at least 2 different courses of a protease inhibitor (PI)-containing regimen, each of which was at least 6 months, or have evidence of mutations to at least 2 different PIs.
- • This study has been changed. The inclusion criteria reflects a change in the prior anti-HIV therapy required, age requirement, and the required CD4 and HIV levels.
- • Exclusion Criteria
- Patients will not be eligible for this trial if they:
- • Are allergic to even 1 study drug or have ever had to stop 1 of these drugs because of a bad reaction to it.
- • Have a history of diabetes, hepatitis C, hepatitis B, or certain diseases of the nervous system, heart, or pancreas.
- • Have had a serious infection within 14 days of starting the study.
- • Need certain drugs that interact with the study drugs. (See Technical Summary for more details.)
- • Are pregnant or breast-feeding.
- • Have had hepatitis within 30 days of study entry.
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
Miami, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Great Neck, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Syracuse, New York, United States
Memphis, Tennessee, United States
Newark, New Jersey, United States
New Orleans, Louisiana, United States
Worcester, Massachusetts, United States
Birmingham, Alabama, United States
Jackson, Mississippi, United States
Richmond, Virginia, United States
Pensacola, Florida, United States
Patients applied
Trial Officials
Grace Aldrovandi
Study Chair
Paul Palumbo
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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