Safety of Saquinavir and High Doses of Lopinavir/Ritonavir in Children With HIV

Completed · Phase 1/Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine the effect of increased doses of lopinavir/ritonavir (LPV/r) and saquinavir (SQV) in HIV infected children who are failing their current antiretroviral regimen

Key facts

Study ID

NCT00084058

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

26

Expected to finish

2006-12-01

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 infected
• HIV RNA viral load greater than 5,000 copies/ml
• At least 6 months of continuous therapy with a protease inhibitor (PI) prior to study entry
• No change in antiretroviral therapy since genotypic resistance testing
• Genotypic resistance testing indicating a primary protease mutation at position 32, 47, 48, 50, 82, or 84 and at least three other mutations in positions 10, 20, 24, 30, 32, 33, 36, 46, 47, 48, 50, 53, 54, 71, 73, 77, 82, 84, or 90 OR phenotypic resistance testing, within 6 months of screening while on a failing regimen, indicating at least a fivefold increase in LPV as compared to wild type HIV
• Parent or legal guardian willing to provide informed consent
• If sexually active, agree to use acceptable methods of contraception
• Have a telephone, pager, or other method of reliable communication with study staff
• Able and willing to swallow study medications

You may not qualify if…

• Any drug toxicity greater than Grade 3 at screening
• Certain abnormal laboratory values
• Acute opportunistic or serious bacterial infection requiring treatment
• Chemotherapy for active cancer
• Any significant diseases (other than HIV infection) that may, in the opinion of the investigator, interfere with the study
• Require certain medications
• History of heart problems
• Family history of prolonged QTc-Interval Syndrome or prolonged QTc-interval at study entry
• Pregnancy or breastfeeding

Where it is running

• UAB, Dept. of Ped., Div. of Infectious Diseases — Birmingham, Alabama, United States
• Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach, California, United States
• UCSF Pediatric AIDS CRS — San Francisco, California, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
• Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases — Baltimore, Maryland, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• Harlem Hosp. Ctr. NY NICHD CRS — New York, New York, United States
• Nyu Ny Nichd Crs — New York, New York, United States
• Strong Memorial Hospital Rochester NY NICHD CRS — Rochester, New York, United States
• Jacobi Med. Ctr. — The Bronx, New York, United States
• DUMC Ped. CRS — Durham, North Carolina, United States
• St. Jude/UTHSC CRS — Memphis, Tennessee, United States
• Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS — San Juan, Puerto Rico
• San Juan City Hosp. PR NICHD CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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