A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine the value of changing anti-HIV medications in children with progressive HIV disease who have received previous treatment. Plasma viral load (the level of HIV in the blood) is probably most effectively reduced by giving patients anti-HIV drugs which affect the virus at various stages of development. Changing the medications may enhance the results of treatment.

Key facts

Study ID

NCT00000902

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

217

Expected to finish

2002-04-01

Last updated by the study team

2021-10-29

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Your child may be eligible for this study if he or she:
• Is HIV-positive.
• Is between the ages of 6 months and 21 years (consent of parent or guardian required if under 18).
• Has an HIV blood level above 50,000 copies/mL on 2 consecutive occasions, while taking anti-HIV therapy.
• Has advanced HIV disease or disease progression while receiving 8 weeks or more of continuous unchanged anti-HIV therapy.
• Is able to receive at least one of the following: RTV, NVP, or NFV.

You may not qualify if…

• Your child will not be eligible for this study if he or she:
• Is receiving treatment for a serious bacterial, viral, or opportunistic (HIV-associated) infection within 14 days prior to study entry.
• Has a history of pancreatitis or peripheral neuropathy.
• Has cancer requiring chemotherapy.
• Is allergic to the study medications.
• Is taking certain medications.
• Is pregnant.

Where it is running

• Univ of South Alabama — Mobile, Alabama, United States
• UCSD Med Ctr / Pediatrics / Clinical Sciences — La Jolla, California, United States
• Long Beach Memorial (Pediatric) — Long Beach, California, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Cedars Sinai / UCLA Med Ctr — Los Angeles, California, United States
• Harbor - UCLA Med Ctr / UCLA School of Medicine — Los Angeles, California, United States
• Children's Hosp of Oakland — Oakland, California, United States
• UCSF / Moffitt Hosp - Pediatric — San Francisco, California, United States
• Children's Hosp of Denver — Denver, Colorado, United States
• Connecticut Children's Med Ctr — Farmington, Connecticut, United States
• Yale Univ Med School — New Haven, Connecticut, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• North Broward Hosp District — Fort Lauderdale, Florida, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Emory Univ Hosp / Pediatrics — Atlanta, Georgia, United States
• Med College of Georgia — Augusta, Georgia, United States
• The Med Ctr Inc — Columbus, Georgia, United States
• Cook County Hosp — Chicago, Illinois, United States
• Univ of Illinois College of Medicine / Pediatrics — Chicago, Illinois, United States
• Chicago Children's Memorial Hosp — Chicago, Illinois, United States
• Tulane Univ / Charity Hosp of New Orleans — New Orleans, Louisiana, United States
• Univ of Maryland at Baltimore / Univ Med Ctr — Baltimore, Maryland, United States
• Johns Hopkins Hosp - Pediatric — Baltimore, Maryland, United States
• Univ of Alabama at Birmingham - Pediatric — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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