A Phase 1/2 interventional study of Atazanavir and Darunavir in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 23 sites in 2 countries. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-11-09.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1/2, Interventional, and Treatment
Limited data exist 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: tenofovir disoproxil fumurate (TDF) and efavirenz (EFV) or nevirapine (NVP); TDF and darunavir (DRV) with or without EFV; and TDF and ritonavir (RTV) with or without EFV.
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: TDF and EFV or NVP; TDF and DRV with or without EFV; and TDF and RTV with or without EFV. In addition, this study will evaluate how age, length of treatment, adverse effects, and genes affect children's response to different anti-HIV combinations.
This study will last between 1 and 7 weeks. Participants in this study will be grouped based on the treatment regimen they are receiving or about to initiate. There are three groups in this study. Group D participants will receive TDF and EFV or NVP; Group E participants will receive TDF and DRV with or without EFV; and Group F participants will receive TDF and RTV with or without EFV. The inclusion of EFV or NVP will be dependent on each participant's prescribed regimen. Participants within each group will be stratified by age and how long they have been receiving their anti-HIV regimens. 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 24 hours. Blood collection for PK studies, a physical exam, and medical history will be done at this visit. Urine collection will occur at all visits for female participants.
Participants will undergo PK testing at least 14 days after initiating their study regimens. 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, 4, 6, 8, 12, and 24 hours after dosing. Participants in Groups E and F may need to repeat PK testing within 6 weeks of initial PK testing at the discretion of the investigator.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 75 is close to the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
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Note: The original Groups A, B, and C have been removed, and Groups D, E, and F have been added per protocol amendment dated 11/16/07.
Inclusion Criteria:
Exclusion Criteria:
TDF and EFV or NVP throughout study
Drug: Efavirenz · Drug: Nevirapine · Drug: Tenofovir disoproxil fumarate · Procedure: Pharmacokinetic Study
TDF and DRV with or without EFV throughout study
Drug: Darunavir · Drug: Efavirenz · Drug: Ritonavir · Drug: Tenofovir disoproxil fumarate · Procedure: Pharmacokinetic Study
TDF and ATV and RTV with or without EFV throughout study
Drug: Atazanavir · Drug: Efavirenz · Drug: Ritonavir · Drug: Tenofovir disoproxil fumarate · Procedure: Pharmacokinetic Study
200 mg to 400 mg orally daily
Also known as: ATV
300 mg or 600 mg orally twice daily
Also known as: DRV
Dosage dependent on participant
Also known as: EFV
Dosage dependent on participant
Also known as: NVP
50 mg or 100 mg orally twice daily
Also known as: RTV
300 mg orally daily
Also known as: TDF
Intensive PK study will occur at least once. This will require a 24-hour inpatient visit.
Also known as: PK Study
Predosage concentration (C0 and C12) and area under the concentration-time curve (AUC)
Time frame: Over the dosing interval
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)