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

NCT ID: NCT00355719

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-02-29

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 protease inhibitor (PI) whose pharmacokinetic profile allows it to be given in a single daily take with a scant impact on lipid metabolism. This second characteristic makes atazanavir a good alternative for patients with a high vascular risk. However, one of its drawbacks is that it may present clinically relevant interactions with other drugs.

Another antiretroviral agent with a scant impact on lipid metabolism is nevirapine. Different studies have described an improvement in lipid profile, as well as a less atherogenic tendency in patients treated with nevirapine. Moreover, the combination of nevirapine with PI drugs in the context of nucleoside-sparing strategies may permit a suitable control of viral replication, and an improvement in the mitochondrial toxicity derived from treatment with NTRI, which may possibly result in a minor incidence or in a clinical improvement of lipodystrophy.

The combination of atazanavir with nevirapine may be of major interest in HIV-infected patients that have had a cardiovascular event (secondary prevention) or are at a high risk of having one (primary prevention). Similarly, this combination of drugs may be promising as a nucleoside-sparing strategy. However, according to preliminary data, the joint administration of nevirapine with atazanavir may lead to a reduction in the atazanavir plasma concentration. Thus, before evaluating the clinical utility of this combination of drugs, pharmacokinetic studies evaluating the existence of significant pharmacokinetic interactions between both are necessary

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nevirapine-atazanavir

Atazanavir/ritonavir 300/100 mg once daily for ≥2 weeks. Nevirapine was added at a dose of 200 mg once daily from days 0 to 14, and 200 mg twice daily from days 14 to 28.

Group Type: EXPERIMENTAL

Atazanavir (Reyataz)

Intervention Type: DRUG

Atazanavir (Reyataz): capsules 150 mg (2 capsules/24h)

Ritonavir (Norvir)

Intervention Type: DRUG

Ritonavir (Norvir): capsules 100 mg (1 capsule/24h)

Nevirapine (Viramune)

Intervention Type: DRUG

Nevirapine (Viramune): tablets 200 mg (1 tablet/12h\*)

Interventions

Atazanavir (Reyataz)

Atazanavir (Reyataz): capsules 150 mg (2 capsules/24h)

Intervention Type: DRUG

Ritonavir (Norvir)

Ritonavir (Norvir): capsules 100 mg (1 capsule/24h)

Intervention Type: DRUG

Nevirapine (Viramune)

Nevirapine (Viramune): tablets 200 mg (1 tablet/12h\*)

Intervention Type: DRUG

Eligibility 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

OTHER

Sponsor Role: collaborator

Hospital San Jaime de Calella

UNKNOWN

Sponsor Role: collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bonaventura Clotet, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

LLuita contra la Sida Foundation-HIV Unit

Jose Molto, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

LLuita contra la Sida Foundation-HIV Unitat

Josep Mª LLibre, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Lluita contra la Sida Foundation- HIV Unit

Sílvia Valero

Role: PRINCIPAL_INVESTIGATOR

Hospital Sant Jaume de Calella

Locations

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Sant Jaume de Calella

Calella, Barcelona, Spain

Countries

Spain

Other Identifiers

2006-001140-31

Identifier Type: -

Identifier Source: secondary_id

NEVIATAZ

Identifier Type: -

Identifier Source: org_study_id