Quality of Life and Changes in Metabolism of Lipids and Glucose After Switching to a Nevirapine-based Regimen in HIV+ Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274001
First received: January 9, 2006
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
HIV Infections
Quality of Life
Drug: Nevirapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Open, Randomised, Multicentre, Comparative Trial, to Evaluate the Benefit of Switching From a PI-based Regimen to a Nevirapine-based Regimen on the Quality of Life, Patient Adherence, Patient's Perception of Fat Redistribution and Metabolic Changes, in HIV+ Patients Suffering From Fat Abnormalities

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Quality of Life (WHOQoL questionnaire) [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Change in triglycerides in plasma [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients perception of fat redistribution [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Adherence to therapy [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Changes in metabolism of lipids and glucose [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Bone mineral loss [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Therapeutic drug levels of antiretrovirals (drug plasma level / IC90) [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Concentration of antiretrovirals in semen and vaginal secretions [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Immunological status [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Incidence and intensity of clinical and adverse events [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 158
Study Start Date: September 2001
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Detailed Description:

Patients will receive one of the current standard of care regimens for the treatment of HIV infection, i.e. nevirapine (Viramune®) must be administered in conjunction with 2NRTIs, as prescribed by the investigator at the study sites. Patients randomized to the nevirapine (Viramune®)-arm of the study will receive 1x200mg tablet once daily for the first 14 days ("lead in" period) and 1x200 mg tablet twice daily at appropriately spaced intervals subsequently, plus their SOC combination of 2NRTIs as prescribed by the investigators (without changing their prior NRTIs). Patients randomized to continue their standard treatment will receive it as prescribed by the investigators. No dose modification of the study drugs is permitted during the trial. The study drug will be dispensed at randomization and every four weeks thereafter until completion of 48 weeks. After 6 months at least of treatment the switch from PI regimen to NVP regimen will be allowed to all patients included in the PI arm according to patient's willingness. In these patients AST and ALT should be checked at time 0 (switch) and every 2 weeks for 2 months.

Study Hypothesis:

Between treatment comparison of Nevirapine-based regimen versus PI-based regimen will be based on a null hypothesis of no treatment difference. The null hypothesis will be no difference between the two arms at week 24 (month 6th), against the alternative hypothesis that the mean change in physical domain of the QoL will be 10 points score (SD=20) and the difference between triglycerides normalized patients will be 20%.

Comparison(s):

The primary analysis on physical domain of QoL will be performed on the changes between last observation carried forward following the LCOF approach (i.e. visit 6 or in case of premature discontinuation visit 5 or 4) and baseline (visit 2) value using fixed-effects ANCOVA model with center and treatment groups as factors and baseline value and MMA type interaction will be also included in the main model.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion criteria:

  • 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

Main Exclusion criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274001

Locations
Italy
Ospedale Regionale
Ancona, Italy, 60020
Ospedale Santa Maria Annunziata
Antella (fi), Italy, 50011
Clinica di Malattie Infettive
Bari, Italy, 70124
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24128
Ospedale degli Infermi di Biella
Biella, Italy, 13900
Istituto di Malattie Infettive
Bologna, Italy, 40138
Ospedale Civile
Brescia, Italy, 25123
Spedali Civili di Brescia
Brescia, Italy, 25123
Ospedale di Circolo di Busto
Busto Arsizio (va), Italy, 21052
Ospedale SS. Trinità
Cagliari, Italy, 09100
Azienda Ospedaliera Arcispedale S. Anna
Ferrara, Italy, 44100
Ospedale San Martino
Genova, Italy, 16132
Presidio Ospedaliero "A. Manzoni"
Lecco, Italy, 23900
Azienda Ospedaliera Carlo Poma
Mantova, Italy, 46100
Ospedale Luigi Sacco
Milano, Italy, 20100
Ospedale Luigi Sacco
Milano, Italy, 20157
Azienda Ospedaliera "Luigi Sacco"
Milano, Italy, 20157
Fondazione Centro S. Raffaele del Monte Tabor
Milano, Italy, 20127
Policlinico Universitario
Modena, Italy, 41100
Ospedale A. Cotugno
Napoli, Italy, 80131
Azienda Ospedaliera di Padova
Padova, Italy, 35128
IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Ospedale Civile
Piacenza, Italy, 29100
Ospedale Cisanello
Pisa, Italy, 35128
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator BI Italy
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00274001     History of Changes
Other Study ID Numbers: 1100.1362
Study First Received: January 9, 2006
Last Updated: October 31, 2013
Health Authority: Italy: Ethics Committee
Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Nevirapine
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 21, 2014