Safety of Saquinavir and High Doses of Lopinavir/Ritonavir in Children With HIV
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Dose Intensification, Pharmacokinetic Sampling, Treatment Experienced, Child
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- UAB, Dept. of Ped., Div. of Infectious Diseases
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
- UCSF Pediatric AIDS CRS
- Chicago Children's CRS
- Tulane/LSU Maternal/Child CRS
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
- Jacobi Med. Ctr.
- Harlem Hosp. Ctr. NY NICHD CRS
- Nyu Ny Nichd Crs
- Strong Memorial Hospital Rochester NY NICHD CRS
- DUMC Ped. CRS
- St. Jude/UTHSC CRS
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
- San Juan City Hosp. PR NICHD CRS