Status:
COMPLETED
Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV
Lead Sponsor:
Germans Trias i Pujol Hospital
Collaborating Sponsors:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Conditions:
HIV Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 ind...
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 antire...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
675 Patients enrolled
Trial Details
Trial ID
NCT00307502
Start Date
January 1 2005
End Date
December 1 2009
Last Update
December 4 2019
Active Locations (6)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
2
Hospital de Figueres
Figueras, Barcelona, Spain, 17600
3
Fundació Hospital-Asil de Granollers
Granollers, Barcelona, Spain, 08400
4
Hospital de Vic
Vic, Barcelona, Spain, 08500