Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment

Completed · Phase 1/Phase 2

Conditions studied: HIV Infections

In brief

Both ritonavir (RTV) and indinavir (IDV) are approved by the FDA to treat HIV, but IDV has not been approved for use in children and the doses for the combination of the two drugs has not been studied in children. The purpose of this study is to find a combination of RTV and IDV that is safe, well tolerated, and produces drug levels in the blood of children that are comparable to effective drug levels in the blood of adults. The effectiveness of the drug combination in decreasing the amount of virus in the body will also be studied. The children enrolled in this study will have high HIV viral loads despite taking anti-HIV drugs.

Key facts

Study ID

NCT00012519

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

29

Expected to finish

2005-07-01

Last updated by the study team

2021-11-01

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV infection
• HIV RNA levels > 10,000 copies/ml within 30 days prior to study entry
• Anti-HIV drug therapy failure while on the same anti-HIV drugs for more than 16 weeks
• Body size above a certain limit (body surface area > 0.48 m2)
• Acceptable methods of contraception
• Consent of parent or legal guardian

You may not qualify if…

• Unable to determine HIV genotypic resistance
• HIV resistant to IDV or RTV at study screening
• Previously received IDV and RTV at the same time
• Need treatment with any medication prohibited by the study
• Glucocorticoids for more than 14 days at study entry
• Cancer requiring chemotherapy
• Drugs affecting the immune system, other than IVIG, within 3 months of study entry
• Certain abnormal laboratory results at study entry
• Pregnant or breast-feeding
• Unable to be followed at a PACTG center during the trial

Where it is running

• Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy — Gainesville, Florida, United States
• Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Metropolitan Hosp. Ctr. — New York, New York, United States
• Columbia IMPAACT CRS — New York, New York, United States
• Harlem Hosp. Ctr. NY NICHD CRS — New York, New York, United States
• SUNY Upstate Med. Univ., Dept. of Peds. — Syracuse, New York, United States
• St. Jude/UTHSC CRS — Memphis, Tennessee, United States
• Texas Children's Hosp. CRS — Houston, Texas, United States
• VCU Health Systems, Dept. of Peds — Richmond, Virginia, United States
• San Juan City Hosp. PR NICHD CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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