Limited data exists about combination anti-HIV treatment regimens in children, including how those drugs are cleared by the body in children. The purpose of this study is to measure the blood levels of the following combinations of anti-HIV drugs in HIV infected chilren: lopinavir/ritonavir (LPV/r) and efavirenz (EFV); LPV/r and saquinavir (SQV); and LPV/r, EFV, and SQV.

Condition	Intervention	Phase
HIV Infections	Drug: Efavirenz  Drug: Lopinavir/Ritonavir  Drug: Saquinavir	Phase I Phase II

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcomes: Mimimum concentration (Cmin) and area under the concentration-time curve (AUC) over the dosing interval
Expected Total Enrollment:  96

Because all of the available non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs) are metabolized by and affect hepatic cytochrome enzymes, combinations of two or more of these drugs produce complex pharmacokinetic (PK) interactions. However, little data exist regarding PK of anti-HIV drug combinations in the pediatric population. The purpose of this study is to assess steady state PK of the following anti-HIV regimens: LPV/r and EFV; LPV/r and SQV; and LPV/r, EFV, and SQV. In addition, this study will evaluate how age, length of treatment, adverse effects, and genes affect children’s response to different anti-HIV combinations.

Participants in this study will be grouped based on the treatment regimen they are receiving or about to initiate. Group A participants will receive LPV/r and EFV; Group B participants will receive LPV/r and SQV; and Group C participants will receive LPV/r, EFV, and SQV. Participants within each group will be stratified by age and how long they have been receiving their anti-HIV regimen. Antiretrovirals will not be provided by this study.

Most participants will have two study visits. The first visit will occur at study entry. Medical history, a physical exam, and blood collection will occur. The second visit will occur within 35 days of study entry and will take approximately 12 hours. Blood collection for PK studies, a physical exam, and medical history will be done at this visit.

Participants will undergo PK testing at least 14 days after initiating their study regimen. Participants will be given a dose of their anti-HIV medications with food. A blood sample will be taken before dosing. Blood samples will also be taken at 1, 2, 3, 4, 6, 8, and 12 hours after dosing. Some participants may need to repeat PK testing within 6 weeks of initial PK testing at the discretion of the investigator.

Ages Eligible for Study:  2 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• HIV infected
• Currently receiving or about to receive one of the following anti-HIV regimens: LPV/r and EFV, LPV/r and SQV, or LPV/r, EFV, and SQV
• Parent or guardian willing and able to provide signed informed consent
• Willing to use acceptable methods of contraception

Exclusion Criteria:

• Liver disease that may affect the metabolism of study drugs
• Certain abnormal laboratory values
• Require certain medications
• Treatment with any anti-HIV or non-antiretroviral drug that could interact with drugs under study in the 14 days prior to initiating therapy
• Treatment requiring the use of rifampin
• Any clinical or laboratory toxicity of Grade 3 or higher at screening
• Pregnant or breastfeeding

Please refer to this study by ClinicalTrials.gov identifier  NCT00260078

Study chairs or principal investigators

Douglas Watson, MD,  Study Chair,  Division of Pediatric Immunology, University of Maryland at Baltimore   

Study ID Numbers:  PACTG P1058
Last Updated:  December 8, 2005
Record first received:  November 29, 2005
ClinicalTrials.gov Identifier:  NCT00260078
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10