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
2 other identifiers
interventional
675
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
Started Jan 2005
Longer than P75 for phase_1 hiv-infections
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 27, 2006
CompletedFirst Posted
Study publicly available on registry
March 28, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedDecember 4, 2019
December 1, 2019
4.9 years
March 27, 2006
December 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint is the plasma concentration of the PI/NNRTI drugs (Ka absorption constant, CI: plasma clearance, Vd: volume of distribution).
In the 12 hour (h) pharmacokinetic curve
Secondary Outcomes (7)
Demographic: race, gender, age
In the 12 h pharmacokinetic curve
Clinical: weight, height, liver/renal impairment, HIV infection stage, tobacco/alcohol consumption
In the 12 h pharmacokinetic curve
Adverse events
In the 12 h pharmacokinetic curve
Laboratory: creatinine, albumin, Quick Index, bilirubin, GOT, GPT, GGT, FA, CD4 lymphocyte count, HIV viral load, HBsAg and anti-HCV, alpha acid glycoprotein
In the 12 h pharmacokinetic curve
Antiretroviral and concomitant treatment, adherence (number of doses omitted in the last two weeks)
In the 12 h pharmacokinetic curve
- +2 more secondary outcomes
Study Arms (11)
NVP
EXPERIMENTALNevirapine
EFV
EXPERIMENTALEfavirenz
INV
EXPERIMENTALIndinavir/ritonavir
NFV
EXPERIMENTALNelfinavir
SQV
EXPERIMENTALSaquinavir/ritonavir
LPV
EXPERIMENTALLopinavir/ritonavir
ATV
EXPERIMENTALAtazanavir
ATV/rtv
EXPERIMENTALAtazanavir/ritonavir
Fos-APV
EXPERIMENTALFos-amprenavir/ritonavir
TPV
EXPERIMENTALTipranavir/ritonavir
DRV
EXPERIMENTALDarunavir/ritonavir
Interventions
Indinavir: capsules 400 mg, 1600 mg/day Ritonavir: capsules 100 mg, 200 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
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
Eligibility Criteria
You may qualify if:
- Age higher than 18 years.
- Documented HIV infection (at least one positive Western-blot)
- Stable antiretroviral treatment with PI or NNRTI, no changes over the last 4 weeks.
- Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or negative pregnancy test.
You may not qualify if:
- Subjects on treatment with more than one PI or with combinations of PI and NNRTI (the use of ritonavir in doses below 400 mg BID will not be regarded as a second PI).
- Treatment with other drugs with known significant pharmacological interactions with the investigational drug over the previous two weeks.
- Unsuitable adherence to treatment (one or more doses omitted in the last week, or two or more doses omitted in the last two weeks).
- Presence of clinical findings or a background of gastrointestinal disease or digestive surgery that may interfere in the pharmacokinetics of the medication.
- Active consumption of alcohol (\>50 grams/day) or illegal drugs (except cannabis).
- In the case of women, pregnancy or breastfeeding.
- Record or suspicion of inability to cooperate properly
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Germans Trias i Pujol Hospital
Badalona, Barcelona, 08916, Spain
Hospital de Figueres
Figueras, Barcelona, 17600, Spain
Fundació Hospital-Asil de Granollers
Granollers, Barcelona, 08400, Spain
Hospital de Vic
Vic, Barcelona, 08500, Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43201, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Related Publications (1)
Molto J, Xinarianos G, Miranda C, Pushpakom S, Cedeno S, Clotet B, Owen A, Valle M. Simultaneous pharmacogenetics-based population pharmacokinetic analysis of darunavir and ritonavir in HIV-infected patients. Clin Pharmacokinet. 2013 Jul;52(7):543-53. doi: 10.1007/s40262-013-0057-6.
PMID: 23494984DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bonaventura Clotet, MD, PhD
Lluita contra la Sida Foundation-HIV Unit
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2006
First Posted
March 28, 2006
Study Start
January 1, 2005
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
December 4, 2019
Record last verified: 2019-12