NCT00355719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

July 24, 2006

Last Update Submit

December 3, 2019

Conditions

HIV Infections

Keywords

NevirapineAtazanavirPharmacokineticsInteractions

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint of the study will be the atazanavir plasma concentration

    at baseline and week 4

Secondary Outcomes (3)

  • Proportion of patients with atazanavir plasma concentrations < 0.15 mg/L

    at baseline and week 4

  • Proportion of patients with nevirapine plasma concentrations > 6.0 mg/L

    at baseline and week 4

  • Incidence of adverse events and anomalies in the laboratory tests (haemogram, AST / ALT / FA / GGT, bilirubin, creatinine, urea).

    during the 8 weeks of follow-up

Study Arms (1)

Nevirapine-atazanavir

EXPERIMENTAL

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.

Drug: Atazanavir (Reyataz)Drug: Ritonavir (Norvir)Drug: Nevirapine (Viramune)

Interventions

Atazanavir (Reyataz)DRUG

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

Nevirapine-atazanavir
Ritonavir (Norvir)DRUG

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

Nevirapine-atazanavir
Nevirapine (Viramune)DRUG

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

Nevirapine-atazanavir

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Sant Jaume de Calella

Calella, Barcelona, 08370, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Atazanavir SulfateRitonavirNevirapine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsThiazolesSulfur CompoundsOrganic ChemicalsAzoles

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2006

First Posted

July 25, 2006

Study Start

January 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

December 4, 2019

Record last verified: 2019-12

Locations

ES(2)