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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274001
• Other study ID #: 1100.1362
• Status: Completed
• Phase: Phase 4
• First received: January 9, 2006
• Last updated: October 31, 2013
• Start date: September 2001
• Est. completion date: March 2004

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• HIV Infections
• Quality of Life

Intervention

Drug:
• Nevirapine

Locations

Country	Name	City	State
Italy	Ospedale Regionale	Ancona
Italy	Ospedale Santa Maria Annunziata	Antella (fi)
Italy	Clinica di Malattie Infettive	Bari
Italy	Ospedali Riuniti di Bergamo	Bergamo
Italy	Ospedale degli Infermi di Biella	Biella
Italy	Istituto di Malattie Infettive	Bologna
Italy	Ospedale Civile	Brescia
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	Azienda Ospedaliera "Luigi Sacco"	Milano
Italy	Fondazione Centro S. Raffaele del Monte Tabor	Milano
Italy	Ospedale Luigi Sacco	Milano
Italy	Ospedale 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 Civile	Piacenza
Italy	Ospedale Cisanello	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life (WHOQoL questionnaire)		up to 48 weeks	No
Primary	Change in triglycerides in plasma		up to 48 weeks	No
Secondary	Patients perception of fat redistribution		up to 48 weeks	No
Secondary	Adherence to therapy		up to 48 weeks	No
Secondary	Changes in metabolism of lipids and glucose		up to 48 weeks	No
Secondary	Bone mineral loss		up to 48 weeks	No
Secondary	Therapeutic drug levels of antiretrovirals (drug plasma level / IC90)		up to 48 weeks	No
Secondary	Concentration of antiretrovirals in semen and vaginal secretions		up to 48 weeks	No
Secondary	Viral load		up to 48 weeks	No
Secondary	Immunological status		up to 48 weeks	No
Secondary	Incidence and intensity of clinical and adverse events		up to 48 weeks	No

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