Pharmacokinetics of Once Daily Darunavir/Ritonavir in HIV-infected

Status Completed

Clinical Trial Summary

Darunavir/ritonavir is one of the preferred antiretroviral agents as part of combination antiretroviral therapy for treatment of HIV-infected adults according to international guidelines. For children 3-12 years old, FDA has approved once daily dosing of darunavir/ritonavir. Dosing recommendations for children 6-12 years old have been approved based on a modelling and simulation procedure by the company. This pharmacokinetic study is designed to validate the proposed dosing recommendation for once daily darunavir/ritonavir in HIV-infected children aged 6-12 years old.

Clinical Trial Description

The EMA and FDA recommended weight band dosing for once daily DRV/r dosing in children 3 -12 years of age has been derived from pharmacokinetic modelling. Results from population pharmacokinetic modelling and simulation in these children predict similar DRV plasma exposures compared to treatment-naïve adults, but has not been formally studied in the target population. Although no clinical trial was conducted to collect exposure-safety data, the predicted exposures from the once daily dosing is supported by exposures observed in a paediatric clinical trial where twice-daily dosing was administered. To validate the weight band based dosing recommendations, we want to evaluate the pharmacokinetics of DRV/r administered once daily, using DRV tablets, in HIV-infected children. Darunavir/ritonavir is one of the preferred antiretroviral agents as part of combination antiretroviral therapy for treatment of HIV-infected adults according to international guidelines. For children 3-12 years old, FDA has approved once daily dosing of darunavir/ritonavir. Dosing recommendations for children 6-12 years old have been approved based on a modelling and simulation procedure by the company. This pharmacokinetic study is designed to validate the proposed dosing recommendation for once daily darunavir/ritonavir in HIV-infected children aged 6-12 years old. ;

Study Design

Related Conditions & MeSH terms

Acquired Immunodeficiency Syndrome
Children
HIV Infections
Human Immunodeficiency Virus

Clinical Trial Details

NCT number	NCT02285478
Study type	Observational
Source	Radboud University
Contact
Status	Completed
Phase
Start date	March 2015
Completion date	July 2016

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03516318` - Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria	N/A
Completed	`NCT04653194` - Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'	Phase 3
Completed	`NCT01792570` - DRV/r + RPV QD: Efficacy and Toxicity Reduction	Phase 3
Active, not recruiting	`NCT04826562` - Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)	Phase 4
Completed	`NCT04191967` - Thermocoagulation for Treatment of Precancerous Cervical Lesions	N/A
Completed	`NCT02812329` - Intervention to Encourage HIV Testing and Counseling Among Adolescents	Phase 1
Completed	`NCT02919306` - Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults	Phase 1/Phase 2
Completed	`NCT02651376` - Safety and Efficacy of Allogenic Adoptive Immune Therapy for Advanced AIDS Patients	Phase 1/Phase 2
Completed	`NCT02516930` - A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China	N/A
Recruiting	`NCT02392884` - HIV Medication Adherence in Underserved Populations	N/A
Completed	`NCT01944371` - Short-term Disulfiram Administration to Reverse Latent HIV Infection: a Dose Escalation Study	Phase 1/Phase 2
Recruiting	`NCT01778374` - Mater-Bronx Rapid HIV Testing Project.	N/A
Completed	`NCT00914225` - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya	N/A
Completed	`NCT01076179` - Kaletra in Combination With Antiretroviral Agents	N/A
Completed	`NCT01490346` - Tissue Drug Levels of HIV Medications	N/A
Completed	`NCT01460433` - Problems With Immune Recovery in the Gut Tissue	N/A
Completed	`NCT00317460` - Buprenorphine and Integrated HIV Care	Phase 4
Terminated	`NCT04240210` - Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)	Phase 4
Active, not recruiting	`NCT04704336` - Integration of Hypertension Management Into HIV Care in Nigeria	N/A
Completed	`NCT03254277` - 3BNC117-LS First-in-Human Phase 1 Study	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pharmacokinetics of Once Daily Darunavir/Ritonavir in HIV-infected Children — DAPHNE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms