Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV
NCT ID: NCT00307502
Last Updated: 2019-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
675 participants
INTERVENTIONAL
2005-01-31
2009-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NVP
Nevirapine
Nevirapine
tablets 200 mg, 400 mg/day
EFV
Efavirenz
Efavirenz
tablets 600 mg, 600 mg/day
INV
Indinavir/ritonavir
Indinavir/ritonavir
Indinavir: capsules 400 mg, 1600 mg/day
Ritonavir: capsules 100 mg, 200 mg/day
NFV
Nelfinavir
Nelfinavir
tablets 250 mg, 2500 mg/day
SQV
Saquinavir/ritonavir
Saquinavir/ritonavir
Saquinavir: tablets 500 mg, 2000 mg/day
Ritonavir: tablets 100 mg, 200 mg/day
LPV
Lopinavir/ritonavir
Lopinavir/ritonavir
tablets lopinavir 200 mg + ritonavir 50 mg, 800/200 mg/day
ATV
Atazanavir
Atazanavir
capsules 200 mg, 400 mg/day
ATV/rtv
Atazanavir/ritonavir
Atazanavir/ritonavir
Atazanavir: capsules 150 mg, 300 mg/day
Ritonavir: capsules 100 mg, 200 mg/day
Fos-APV
Fos-amprenavir/ritonavir
Fos-amprenavir/ritonavir
Fos-amprenavir: capsules 700 mg, 1400 mg/day
Ritonavir: capsules 100 mg, 200 mg/day
TPV
Tipranavir/ritonavir
Tipranavir/ ritonavir
Tipranavir: tablets 250 mg, 1000 mg/day
Ritonavir: capsules 100 mg, 400 mg/day
DRV
Darunavir/ritonavir
Darunavir/ritonavir
Darunavir: tablets 300 mg, 1200 mg/day
Ritonavir: capsules 100 mg, 200 mg/day
Interventions
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Nevirapine
tablets 200 mg, 400 mg/day
Efavirenz
tablets 600 mg, 600 mg/day
Indinavir/ritonavir
Indinavir: capsules 400 mg, 1600 mg/day
Ritonavir: capsules 100 mg, 200 mg/day
Nelfinavir
tablets 250 mg, 2500 mg/day
Saquinavir/ritonavir
Saquinavir: tablets 500 mg, 2000 mg/day
Ritonavir: tablets 100 mg, 200 mg/day
Lopinavir/ritonavir
tablets lopinavir 200 mg + ritonavir 50 mg, 800/200 mg/day
Atazanavir
capsules 200 mg, 400 mg/day
Atazanavir/ritonavir
Atazanavir: capsules 150 mg, 300 mg/day
Ritonavir: capsules 100 mg, 200 mg/day
Fos-amprenavir/ritonavir
Fos-amprenavir: capsules 700 mg, 1400 mg/day
Ritonavir: capsules 100 mg, 200 mg/day
Tipranavir/ ritonavir
Tipranavir: tablets 250 mg, 1000 mg/day
Ritonavir: capsules 100 mg, 400 mg/day
Darunavir/ritonavir
Darunavir: tablets 300 mg, 1200 mg/day
Ritonavir: capsules 100 mg, 200 mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Documented HIV infection (at least one positive Western-blot)
3. Stable antiretroviral treatment with PI or NNRTI, no changes over the last 4 weeks.
4. 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.
Exclusion Criteria
2. Treatment with other drugs with known significant pharmacological interactions with the investigational drug over the previous two weeks.
3. Unsuitable adherence to treatment (one or more doses omitted in the last week, or two or more doses omitted in the last two weeks).
4. Presence of clinical findings or a background of gastrointestinal disease or digestive surgery that may interfere in the pharmacokinetics of the medication.
5. Active consumption of alcohol (\>50 grams/day) or illegal drugs (except cannabis).
6. In the case of women, pregnancy or breastfeeding.
7. Record or suspicion of inability to cooperate properly
18 Years
80 Years
ALL
No
Sponsors
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Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
OTHER
Germans Trias i Pujol Hospital
OTHER
Responsible Party
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Principal Investigators
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Bonaventura Clotet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Lluita contra la Sida Foundation-HIV Unit
Locations
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Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain
Hospital de Figueres
Figueras, Barcelona, Spain
Fundació Hospital-Asil de Granollers
Granollers, Barcelona, Spain
Hospital de Vic
Vic, Barcelona, Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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References
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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.
Other Identifiers
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2004-001516-32
Identifier Type: -
Identifier Source: secondary_id
PK-TRANSVERSAL
Identifier Type: -
Identifier Source: org_study_id
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