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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00274001 |
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 IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized PI Switch |
Estimated Enrollment: | 159 |
Study Start Date: | September 2001 |
Estimated Study Completion Date: | March 2004 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion criteria:
Main Exclusion criteria:
Italy | |
Azienda Ospedaliera di Padova | |
PADOVA, Italy, 35128 | |
Fondazione Centro S. Raffaele del Monte Tabor | |
MILANO, Italy, 20127 | |
IRCCS Policlinico San Matteo | |
PAVIA, Italy, 27100 | |
Ospedale di Circolo di Busto | |
BUSTO ARSIZIO (VA), Italy, 21052 | |
Ospedale Civile | |
BRESCIA, Italy, 25123 | |
Ospedale A. Cotugno | |
NAPOLI, Italy, 80131 | |
Ospedale degli Infermi di Biella | |
BIELLA, Italy, 13900 | |
Ospedale Luigi Sacco | |
MILANO, Italy, 20100 | |
Azienda Ospedaliera "Luigi Sacco" | |
MILANO, Italy, 20157 | |
Istituto di Malattie Infettive | |
BOLOGNA, Italy, 40138 | |
Ospedali Riuniti di Bergamo | |
BERGAMO, Italy, 24128 | |
Presidio Ospedaliero "A. Manzoni" | |
LECCO, Italy, 23900 | |
Policlinico Universitario | |
MODENA, Italy, 41100 | |
Ospedale Regionale | |
ANCONA, Italy, 60020 | |
Ospedale Civile | |
PIACENZA, Italy, 29100 | |
Ospedale Luigi Sacco | |
MILANO, Italy, 20157 | |
Clinica di Malattie Infettive | |
BARI, Italy, 70124 | |
Ospedale SS. Trinità | |
CAGLIARI, Italy, 09100 | |
Ospedale Cisanello | |
Pisa, Italy, 35128 | |
Ospedale Santa Maria Annunziata | |
ANTELLA (FI), Italy, 50011 | |
Ospedale San Martino | |
GENOVA, Italy, 16132 | |
Azienda Ospedaliera Arcispedale S. Anna | |
FERRARA, Italy, 44100 | |
Azienda Ospedaliera Carlo Poma | |
MANTOVA, Italy, 46100 | |
Spedali Civili di Brescia | |
BRESCIA, Italy, 25123 |
Study Chair: | Boehringer Ingelheim Study Coordinator | BI Italy |
Study ID Numbers: | 1100.1362 |
Study First Received: | January 9, 2006 |
Last Updated: | November 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00274001 |
Health Authority: | Italy: Ethics Committee; Italy: The Italian Medicines Agency |
Virus Diseases Nevirapine Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Quality of Life Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |