Randomized PI Switch - Quality of Life
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.
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 Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Conditions
HIV Infections
Intervention
Nevirapine
Location
Ospedale Regionale
Ancona
Italy
60020
Status
Completed
Source
Boehringer Ingelheim Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00274001
- Information obtained from ClinicalTrials.gov on June 14, 2012
Medical and Biotech [MESH] Definitions
Encephalitis, Viral
Inflammation of brain parenchymal tissue as a result of viral infection. Encephalitis may occur as primary or secondary manifestation of TOGAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; BUNYAVIRIDAE INFECTIONS; PICORNAVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RETROVIRIDAE INFECTIONS; and ARENAVIRIDAE INFECTIONS.
Meningitis, Viral
Viral infections of the leptomeninges and subarachnoid space. TOGAVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; RUBELLA; BUNYAVIRIDAE INFECTIONS; ORBIVIRUS infections; PICORNAVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RHABDOVIRIDAE INFECTIONS; ARENAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; JC VIRUS infections; and RETROVIRIDAE INFECTIONS may cause this form of meningitis. Clinical manifestations include fever, headache, neck pain, vomiting, PHOTOPHOBIA, and signs of meningeal irritation. (From Joynt, Clinical Neurology, 1996, Ch26, pp1-3)
Paramyxoviridae Infections
Infections with viruses of the family PARAMYXOVIRIDAE. This includes MORBILLIVIRUS INFECTIONS; RESPIROVIRUS INFECTIONS; PNEUMOVIRUS INFECTIONS; HENIPAVIRUS INFECTIONS; AVULAVIRUS INFECTIONS; and RUBULAVIRUS INFECTIONS.
Nevirapine
A potent, non-nucleoside reverse transcriptase inhibitor used in combination with nucleoside analogues for treatment of HIV infection and AIDS.
Central Nervous System Infections
Pathogenic infections of the brain, spinal cord, and meninges. DNA VIRUS INFECTIONS; RNA VIRUS INFECTIONS; BACTERIAL INFECTIONS; MYCOPLASMA INFECTIONS; SPIROCHAETALES INFECTIONS; fungal infections; PROTOZOAN INFECTIONS; HELMINTHIASIS; and PRION DISEASES may involve the central nervous system as a primary or secondary process.
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