A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir 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
Clinical trials in adults and children suggest that SQV-SGC has advantages over other protease inhibitors in terms of tolerability, safety, and effectiveness in patients who have failed therapy with other protease inhibitors. \[AS PER AMENDMENT 11/24/99: Pharmacokinetic data from this study demonstrate lower than expected plasma SQV exposures, particularly in Arm 1. Based on these data, patients in the study will be offered the opportunity to adjust their doses. Ritonavir added to the Arm 1 regimen is expected to significantly increase SQV-SGC plasma levels and allow twice-daily dosing for ...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Your child may be eligible for this study if he or she:
- • Is HIV-positive.
- • Is 3 to 16 years of age (consent of parent or guardian is required).
- • Has an HIV level greater than 10,000 copies/ml.
- • Has never taken at least one of the following anti-HIV drugs: lamivudine, zidovudine, stavudine, or didanosine.
- • Is able to swallow capsules and tablets.
- • Exclusion Criteria
- Your child will not be eligible if he or she:
- • Has cancer requiring chemotherapy.
- • Has an acute opportunistic (AIDS-related) infection requiring therapy.
- • Has had two or more episodes of moderate or severe diarrhea or vomiting in the 3 months prior to study entry.
- • Has ever taken SQV or NFV.
- • Is pregnant or breast-feeding.
- • Is taking certain medications, including those that would interfere with the study drugs.
Trial Officials
Mark Kline
Study Chair
Courtney Fletcher
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
Long Beach, California, United States
Oakland, California, United States
San Francisco, California, 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
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Albany, New York, 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
New York, New York, United States
Stony Brook, New York, 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
New Orleans, Louisiana, United States
Birmingham, Alabama, United States
Riviera Beach, Florida, United States
Jackson, Mississippi, United States
Richmond, Virginia, United States
Birmingham, Alabama, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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