Study to Evaluate the Influence of Nevirapine to Atazanavir in Steady State Equilibrium in HIV Patients

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Collaborators: Fundacio Lluita Contra la SIDA; Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia; Hospital San Jaime de Calella
• Treatments: Atazanavir Sulfate; Nevirapine; Ritonavir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.