Status:
COMPLETED
Study to Evaluate the Influence of Nevirapine to Atazanavir in Steady State Equilibrium in HIV Patients
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
Hospital San Jaime de Calella
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the influence of nevirapine in exposure to atazanavir boosted with ritonavir, in steady state equilibrium, in HIV-infected adult patients.
Detailed Description
In recent years, new treatment strategies have appeared aimed at reducing the risk of treatment-derived toxicity without compromising efficacy. Of the recent antiretroviral drugs, atazanavir is a pro...
Eligibility Criteria
Inclusion
- Age \>=18 years.
- Patients infected by HIV-1 (at least one documented positive Western-Blot).
- Stable antiretroviral treatment with atazanavir boosted with ritonavir (300/100 mg QD) for at least 14 days.
- Absence of acute infections and/or tumours in the three months prior to inclusion.
- Subject able to follow the treatment period.
- Transaminase values (AST/ALT) below 5 times the upper limit of the interval of normality.
- In women, negative pregnancy test or not of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or undertaking to use a barrier contraceptive method during the study.
- Signature of the informed consent.
- Undetectable viral load.
Exclusion
- Failure to comply with any of the inclusion criteria.
- Record of allergic hypersensitivity or intolerance to the investigational medication.
- Any clinical or historic observation that might interfere in the pharmacokinetics of the medication, such as gastrointestinal diseases or surgery (except herniotomy or appendectomy), alterations in the composition of plasma proteins, any indication of hepatic or renal dysfunction.
- Patients that have been given tenofovir, omeprazole or other proton pump inhibitors or any other medication with relevant interactions with atazanavir within the two weeks prior to the screening visit.
- Active consumption of alcohol (\> 50 g/day) or illegal drugs (except cannabis).
- Suspicion of unsuitable antiretroviral treatment compliance.
- Pregnancy or breastfeeding.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00355719
Start Date
January 1 2007
End Date
February 1 2008
Last Update
December 4 2019
Active Locations (2)
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1
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital Sant Jaume de Calella
Calella, Barcelona, Spain, 08370