A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 09, 2025
Completed
Keywords
ClinConnect Summary
The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.
In Stage 1 of the study, a minimum of 22 patients are randomized to each of three treatment arms: didanosine (ddI) plus AZT plus nevirapine (NVP); ddI plus AZT; and ddI plus NVP. After 12 weeks of treatment, the study proceeds to Stage 2 provided at least 40 percent of patients in Stage 1 show a reduction of at least 40 percent from baseline ICD...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication:
- Allowed:
- • Erythropoietin.
- Concurrent Treatment:
- Allowed:
- • Transfusion.
- Patients must have:
- • Progressive HIV disease.
- • At least 24 weeks prior cumulative nucleoside analog antiretroviral monotherapy or combination therapy.
- • Exclusion Criteria
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- • Active malignancy requiring chemotherapy.
- • Currently receiving therapy in an ACTG primary therapy or salvage protocol who have NOT met an endpoint on that study.
- • Known intolerance (other than hematologic) or toxicity to ddI, AZT, or NVP at the doses used in this study.
- Concurrent Medication:
- Excluded (unless exemption made by study chair):
- • Oral anticoagulants (warfarin, dicumarol).
- • Oral contraceptives.
- • Digitalis glycosides.
- • Phenytoin.
- • Theophylline.
- Patients with the following prior conditions are excluded:
- • History of clinical pancreatitis.
- • History of grade 2 or worse peripheral neuropathy.
- Prior Treatment:
- Excluded:
- • Acute treatment for a serious bacterial, viral, or opportunistic infection within 14 days prior to 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
Springfield, Massachusetts, United States
Seattle, Washington, United States
Bronx, New York, United States
Birmingham, Alabama, 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
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
Chicago, Illinois, United States
Baltimore, Maryland, United States
Baltimore, Maryland, 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
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
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
Valhalla, New York, United States
Durham, North Carolina, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
Bayamon, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Hershey, Pennsylvania, United States
Farmington, Connecticut, United States
New Orleans, Louisiana, United States
Worcester, Massachusetts, United States
Jacksonville, Florida, United States
Durham, North Carolina, United States
Dayton, Ohio, United States
New York, New York, United States
Norfolk, Virginia, United States
Bronx, New York, United States
Hershey, Pennsylvania, United States
Patients applied
Trial Officials
Burchett S
Study Chair
Luzuriaga K
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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