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

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ClinicalTrials.gov Identifier: NCT00355719
Recruitment Status : Completed
First Posted : July 25, 2006
Last Update Posted : June 17, 2009
Sponsor:
Collaborators:
Fundacio Lluita Contra la SIDA
Hospital San Jaime de Calella
Information provided by:
Germans Trias i Pujol Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Atazanavir (Reyataz) Drug: Ritonavir (Norvir) Drug: Nevirapine (Viramune) Phase 4

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


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Pilot Trial to Evaluate the Influence of Nevirapine in Exposure to Atazanavir in Steady State Equilibrium in HIV-Infected Adult Patients.
Study Start Date : January 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Intervention Details:
  • Drug: Atazanavir (Reyataz)
    Atazanavir (Reyataz): capsules 150 mg (2 capsules/24h)
  • Drug: Ritonavir (Norvir)
    Ritonavir (Norvir): capsules 100 mg (1 capsule/24h)
  • Drug: Nevirapine (Viramune)
    Nevirapine (Viramune): tablets 200 mg (1 tablet/12h*)

Outcome Measures
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Primary Outcome Measures :
  1. The primary endpoint of the study will be the atazanavir plasma concentration [ Time Frame: at baseline and week 4 ]

Secondary Outcome Measures :
  1. Proportion of patients with atazanavir plasma concentrations < 0.15 mg/L [ Time Frame: at baseline and week 4 ]
  2. Proportion of patients with nevirapine plasma concentrations > 6.0 mg/L [ Time Frame: at baseline and week 4 ]
  3. Incidence of adverse events and anomalies in the laboratory tests (haemogram, AST / ALT / FA / GGT, bilirubin, creatinine, urea). [ Time Frame: during the 8 weeks of follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355719


Locations
Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Sant Jaume de Calella
Calella, Barcelona, Spain, 08370
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Hospital San Jaime de Calella
Investigators
Principal Investigator: Bonaventura Clotet, MD,PhD LLuita contra la Sida Foundation-HIV Unit
Principal Investigator: Jose Molto, MD,PhD LLuita contra la Sida Foundation-HIV Unitat
Principal Investigator: Josep Mª LLibre, MD,PhD Lluita contra la Sida Foundation- HIV Unit
Principal Investigator: Sílvia Valero Hospital Sant Jaume de Calella
More Information
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Responsible Party: LLuita Sida Foundation
ClinicalTrials.gov Identifier: NCT00355719     History of Changes
Other Study ID Numbers: NEVIATAZ
2006-001140-31
First Posted: July 25, 2006    Key Record Dates
Last Update Posted: June 17, 2009
Last Verified: June 2009

Keywords provided by Germans Trias i Pujol Hospital:
Nevirapine
Atazanavir
Pharmacokinetics
Interactions

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Atazanavir Sulfate
Nevirapine
HIV Protease Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers