NCT00307502

Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV

Cross-sectional Study for the Characterisation of the Pharmacokinetic Parameters of Protease Inhibitors and Non-nucleoside Analog Reverse Transcriptase Inhibitors in the Spanish Population of HIV-infected Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 675 (actual)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterise the pharmacokinetic profiles of non-nucleoside analog reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs), and the influence of the individual characteristics on the pharmacokinetic parameters in the Spanish population of HIV-infected subjects.

Detailed description

The antiretrovirals were administered conventionally according to fixed dosage systems, or depending on the weight of the individual in the case of certain agents. However, the plasma levels of antiretrovirals following the administration of a fixed dose present a marked interindividual variability. Moreover, a significant proportion of the patients on treatment with PIs presented plasma levels regarded as suboptimal in previous studies. Moreover, for the correct modification of the dosage of a drug, populational data on its pharmacokinetic behaviour during the dosing interval is required. Only by integrating this information with the specific characteristics of each individual is it possible, using mathematical models, to estimate the effect that a modification of the dosage of the drug would have on its plasma concentration. However, populational data on the pharmacokinetic behaviour of antiretroviral agents are still very limited at this moment, and have not always been obtained in populations similar to the one to which they are to be applied. Thus, knowing the pharmacokinetic behaviour of the antiretroviral agents in our population and the influence of certain individual characteristics on this behaviour may be of great interest, since only in this way will we be able to tailor the dosage of antiretrovirals reliably in our patients.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Nevirapine	tablets 200 mg, 400 mg/day
DRUG	Efavirenz	tablets 600 mg, 600 mg/day
DRUG	Indinavir/ritonavir	Indinavir: capsules 400 mg, 1600 mg/day Ritonavir: capsules 100 mg, 200 mg/day
DRUG	Nelfinavir	tablets 250 mg, 2500 mg/day
DRUG	Saquinavir/ritonavir	Saquinavir: tablets 500 mg, 2000 mg/day Ritonavir: tablets 100 mg, 200 mg/day
DRUG	Lopinavir/ritonavir	tablets lopinavir 200 mg + ritonavir 50 mg, 800/200 mg/day
DRUG	Atazanavir	capsules 200 mg, 400 mg/day
DRUG	Atazanavir/ritonavir	Atazanavir: capsules 150 mg, 300 mg/day Ritonavir: capsules 100 mg, 200 mg/day
DRUG	Fos-amprenavir/ritonavir	Fos-amprenavir: capsules 700 mg, 1400 mg/day Ritonavir: capsules 100 mg, 200 mg/day
DRUG	Tipranavir/ ritonavir	Tipranavir: tablets 250 mg, 1000 mg/day Ritonavir: capsules 100 mg, 400 mg/day
DRUG	Darunavir/ritonavir	Darunavir: tablets 300 mg, 1200 mg/day Ritonavir: capsules 100 mg, 200 mg/day

Timeline

• Start date: 2005-01-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2006-03-28
• Last updated: 2019-12-04

Locations

6 sites across 1 country: Spain