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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

January 9, 2006
October 31, 2013
September 2001
March 2004   (final data collection date for primary outcome measure)
  • 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 ]
The WHOQOL questionnaire will be administered at entry and at week 12, 24, 36 and 48 and at any time of possible study discontinuation. The determination of triglycerides will be performed at screening and at week 4, 8, 12, 24, 36 and 48.
Complete list of historical versions of study NCT00274001 on ClinicalTrials.gov Archive Site
  • 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 ]
QAT, general assessment, CD4+, CD8+, plasma HIV-1 RNA, haematology, biochemestry, hepatitis C/B markers, anthropometric and skin folds measurement, DEXA, bone mineral loss parameters, NVP concentration in saliva, in semen and in vaginal secretions.
Not Provided
Not Provided
 
Quality of Life and Changes in Metabolism of Lipids and Glucose After Switching to a Nevirapine-based Regimen in HIV+ Patients
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • HIV Infections
  • Quality of Life
Drug: Nevirapine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
March 2004
March 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00274001
1100.1362
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator BI Italy
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP