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

Phase 4

Completed

• Conditions: Quality of Life; HIV Infections

• Registration Number: NCT00274001
• Lead Sponsor: Boehringer Ingelheim

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.

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.

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-09
• Study First Posted: 2006-01-10
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of Life (WHOQoL questionnaire)	up to 48 weeks
Change in triglycerides in plasma	up to 48 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in metabolism of lipids and glucose	up to 48 weeks
Bone mineral loss	up to 48 weeks
Patients perception of fat redistribution	up to 48 weeks
Adherence to therapy	up to 48 weeks
Immunological status	up to 48 weeks
Incidence and intensity of clinical and adverse events	up to 48 weeks
Viral load	up to 48 weeks
Therapeutic drug levels of antiretrovirals (drug plasma level / IC90)	up to 48 weeks
Concentration of antiretrovirals in semen and vaginal secretions	up to 48 weeks

Trial Locations

Locations (22)

Ospedale degli Infermi di Biella; 🇮🇹 Biella, Italy

Ospedale Civile; 🇮🇹 Piacenza, Italy

Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Ospedale di Circolo di Busto; 🇮🇹 Busto Arsizio (va), Italy

Ospedale SS. Trinità; 🇮🇹 Cagliari, Italy

Azienda Ospedaliera Arcispedale S. Anna; 🇮🇹 Ferrara, Italy

Ospedale San Martino; 🇮🇹 Genova, Italy

Presidio Ospedaliero "A. Manzoni"; 🇮🇹 Lecco, Italy

Azienda Ospedaliera Carlo Poma; 🇮🇹 Mantova, Italy

Fondazione Centro S. Raffaele del Monte Tabor; 🇮🇹 Milano, Italy

Azienda Ospedaliera "Luigi Sacco"; 🇮🇹 Milano, Italy

Policlinico Universitario; 🇮🇹 Modena, Italy

Ospedale A. Cotugno; 🇮🇹 Napoli, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Ospedale Cisanello; 🇮🇹 Pisa, Italy

Ospedale Santa Maria Annunziata; 🇮🇹 Antella (fi), Italy

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy

Istituto di Malattie Infettive; 🇮🇹 Bologna, Italy

Ospedale Regionale; 🇮🇹 Ancona, Italy

Clinica di Malattie Infettive; 🇮🇹 Bari, Italy

Ospedale Luigi Sacco; 🇮🇹 Milano, Italy