Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring protease inhibitors, non-nucleoside analog reverse transcriptase inhibitors, pharmacokinetic models, treatment experienced, HIV
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Germans Trias i Pujol Hospital
- Hospital de Figueres
- Fundació Hospital-Asil de Granollers
- Hospital de Vic
- Hospital Universitari Sant Joan de Reus
- Hospital de la Santa Creu i Sant Pau
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
NVP
EFV
INV
NFV
SQV
LPV
ATV
ATV/rtv
Fos-APV
TPV
DRV
Nevirapine
Efavirenz
Indinavir/ritonavir
Nelfinavir
Saquinavir/ritonavir
Lopinavir/ritonavir
Atazanavir
Atazanavir/ritonavir
Fos-amprenavir/ritonavir
Tipranavir/ritonavir
Darunavir/ritonavir