Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Nevirapine; Efavirenz; Indinavir/ritonavir; Nelfinavir; Saquinavir/ritonavir; Lopinavir/ritonavir; Atazanavir; Atazanavir/ritonavir; Fos-amprenavir/ritonavir; Tipranavir/ ritonavir; Darunavir/ritonavir
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): tablets 200 mg, 400 mg/day; tablets 600 mg, 600 mg/day; Indinavir: capsules 400 mg, 1600 mg/day
Ritonavir: capsules 100 mg, 200 mg/day; tablets 250 mg, 2500 mg/day; Saquinavir: tablets 500 mg, 2000 mg/day
Ritonavir: tablets 100 mg, 200 mg/day; tablets lopinavir 200 mg + ritonavir 50 mg, 800/200 mg/day; capsules 200 mg, 400 mg/day; Atazanavir: capsules 150 mg, 300 mg/day
Ritonavir: capsules 100 mg, 200 mg/day; Fos-amprenavir: capsules 700 mg, 1400 mg/day
Ritonavir: capsules 100 mg, 200 mg/day; Tipranavir: tablets 250 mg, 1000 mg/day
Ritonavir: capsules 100 mg, 400 mg/day; Darunavir: tablets 300 mg, 1200 mg/day
Ritonavir: capsules 100 mg, 200 mg/day
Other intervention name(s): Viramune; Sustiva; Crixivan/norvir; Viracept; Invirase/Norvir; Kaletra; Reyataz; Reyataz/Norvir; Telzir/norvir; Aptivus/Norvir; Prezista/norvir
Intervention MeSH terms: Ritonavir; Lopinavir; Atazanavir Sulfate; Darunavir; Nelfinavir; Indinavir; Saquinavir; Amprenavir; Fosamprenavir; Nevirapine; Tipranavir; Efavirenz
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: protease inhibitors; non-nucleoside analog reverse transcriptase inhibitors; pharmacokinetic models; treatment experienced; HIV