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

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.

Conditions

• HIV Infections

Interventions

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

Sponsors & Collaborators

• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

  collaborator OTHER

• Germans Trias i Pujol Hospital

  lead OTHER

Principal Investigators

• Bonaventura Clotet, MD, PhD · Lluita contra la Sida Foundation-HIV Unit

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-01-31

Primary Completion

2009-12-31

Completion

2009-12-31

Countries

• Spain

Study Locations