NCT00274001

Brief Summary

The purpose of this trial is to compare the effect of switching to nevirapine (Viramune®)-containing regimen on quality of life of patients with fat abnormalities and virological control whilst receiving a PI-based regimen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for phase_4 hiv-infections

Timeline
Completed

Started Sep 2001

Geographic Reach
1 country

24 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

Study Start

First participant enrolled

September 1, 2001

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2006

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

2.5 years

First QC Date

January 9, 2006

Last Update Submit

October 31, 2013

Conditions

HIV InfectionsQuality of Life

Outcome Measures

Primary Outcomes (2)

  • Quality of Life (WHOQoL questionnaire)

    up to 48 weeks

  • Change in triglycerides in plasma

    up to 48 weeks

Secondary Outcomes (9)

  • Patients perception of fat redistribution

    up to 48 weeks

  • Adherence to therapy

    up to 48 weeks

  • Changes in metabolism of lipids and glucose

    up to 48 weeks

  • Bone mineral loss

    up to 48 weeks

  • Therapeutic drug levels of antiretrovirals (drug plasma level / IC90)

    up to 48 weeks

  • +4 more secondary outcomes

Interventions

NevirapineDRUG

Eligibility Criteria

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

You may qualify if:

  • Subject suffering with clinically evident fat redistribution including the lipodystrophic syndrome and/or with abnormal values of triglycerides, cholesterol and/or insulin resistance
  • Subject on treatment with HAART including PIs for at least 9 months, without therapeutic changes for at least 6 months
  • Baseline CD4+ \>200 cells/mm3
  • HIV-1 RNA levels \<200 copies/mL at baseline and during the previous 6 months

You may not qualify if:

  • Subject with other serious or chronic disease unrelated to HIV
  • Subject with active invasive infections
  • Subject with Karnofsky score less than 50
  • Prior NNRTs experience
  • Documented or suspected acute hepatitis within 30 days prior to baseline visit, irrespective of AST and ALT values that are \>5 ULN
  • Subject receiving hypolipidemic and/or antidiabetic drugs at study entry
  • Subjects with central nervous system disease or pre-existing mental disturbance
  • Subjects on methadone chronic treatment at study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Ospedale Regionale

Ancona, 60020, Italy

Location

Ospedale Santa Maria Annunziata

Antella (fi), 50011, Italy

Location

Clinica di Malattie Infettive

Bari, 70124, Italy

Location

Ospedali Riuniti di Bergamo

Bergamo, 24128, Italy

Location

Ospedale degli Infermi di Biella

Biella, 13900, Italy

Location

Istituto di Malattie Infettive

Bologna, 40138, Italy

Location

Ospedale Civile

Brescia, 25123, Italy

Location

Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Ospedale di Circolo di Busto

Busto Arsizio (va), 21052, Italy

Location

Ospedale SS. Trinità

Cagliari, 09100, Italy

Location

Azienda Ospedaliera Arcispedale S. Anna

Ferrara, 44100, Italy

Location

Ospedale San Martino

Genova, 16132, Italy

Location

Presidio Ospedaliero "A. Manzoni"

Lecco, 23900, Italy

Location

Azienda Ospedaliera Carlo Poma

Mantova, 46100, Italy

Location

Ospedale Luigi Sacco

Milan, 20100, Italy

Location

Fondazione Centro S. Raffaele del Monte Tabor

Milan, 20127, Italy

Location

Azienda Ospedaliera "Luigi Sacco"

Milan, 20157, Italy

Location

Ospedale Luigi Sacco

Milan, 20157, Italy

Location

Policlinico Universitario

Modena, 41100, Italy

Location

Ospedale A. Cotugno

Napoli, 80131, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Ospedale Civile

Piacenza, 29100, Italy

Location

Ospedale Cisanello

Pisa, 35128, Italy

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine

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 Compounds

Study Officials

  • Boehringer Ingelheim Study Coordinator

    BI Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 9, 2006

First Posted

January 10, 2006

Study Start

September 1, 2001

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

IT(24)