Clinical trial NCT00543803: Observational Non-interventional Study With Viramune® in Combination With Truvada® in HIV-infected Patients
Official title: Observational Non-interventional Study Evaluating the Safety and Efficacy of Truvada + Nevirapine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV Patients

Brief summary: This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and Truvada (tenofovir and emtricitabine).


Eligibility criteria: Inclusion criteria

* male and female adult HIV type 1 infected patients, who have either not been treated previously, whose previous combination treatment with PIs has failed, or who have to switch their previous treatment from protease inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRT)I due to side effects or intolerability after achieving suppression of viral load below the limit of detection.
* Viramune (nevirapine) is indicated as part of combination therapy for the antiviral treatment of HIV-1 infected patients with advanced or progressive immunodeficiency.
* Truvada (tenofovir and emtricitabine) is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.

Exclusion criteria

* Age \< 18 years
* Pregnant female patients
* Hypersensitivity to the active substance or to any of the excipients of Viramune (nevirapine) or Truvada (tenofovir and emtricitabine).
* Viramune (nevirapine) should not be readministered to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.
* Viramune (nevirapine) should not be used in patients with severe hepatic impairment (Child-Pugh C) or pre-treatment aspartine transaminase (ASAT) or alanine transaminase (ALAT) \> 5 upper limit normal (ULN) until baseline ASAT/ALAT are stabilised \< 5 ULN.
* Viramune (nevirapine) should not be readministered in patients who previously had ASAT or ALAT \> 5 ULN during Viramune (nevirapine) therapy and had recurrence of liver function abnormalities upon readministration of Viramune (nevirapine)
* Herbal preparations containing St Johns wort (Hypericum perforatum) must not be used while taking Viramune (nevirapine) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine
* The available pharmacokinetic data suggest that the concomitant use of rifampicin and Viramune (nevirapine) is not recommended.

Primary outcomes:
measure: Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment
timeFrame: from baseline to last value on treatment in between 36 months
measure: Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment
timeFrame: from baseline to last value on treatment in between 36 months
measure: Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment
timeFrame: from baseline to last value on treatment in between 36 months
measure: Summary of Change From Baseline in Creatinine to Last Value on Treatment
timeFrame: from baseline to last value on treatment in between 36 months
measure: Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment
timeFrame: from baseline to last value on treatment in between 36 months
measure: Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment
timeFrame: from baseline to last value on treatment in between 36 months
measure: Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment
timeFrame: from baseline to last value on treatment in between 36 months
measure: Summary of Change From Baseline in Triglycerides to Last Value on Treatment
timeFrame: from baseline to last value on treatment in between 36 months
measure: Summary of Change From Baseline in Glucose to Last Value on Treatment
timeFrame: from baseline to last value on treatment in between 36 months
Secondary outcomes:
measure: Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment
timeFrame: from baseline to last value on treatment in between 36 months
measure: Summary of Change From Baseline in CD4+ Count to Last Value on Treatment
timeFrame: from baseline to last value on treatment in between 36 months
measure: Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator
timeFrame: from baseline to last value on treatment in between 36 months
measure: Investigator's Global Clinical Assessment of Patient General Health Status
timeFrame: from baseline to last value on treatment in between 36 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1100.1492.1 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 10
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 11
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 12
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 13
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 14
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 5
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 6
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 7
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 8
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 9
city: Dortmund
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Duisburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Frankfurt/Main
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Frankfurt/Main
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Frankfurt/Main
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Frankfurt/Main
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: Frankfurt/Oder
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Freiburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Karlsruhe
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Koblenz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Köln
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Köln
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Leipzig
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Leipzig
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Magdeburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mannheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 5
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: Nürnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Nürnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Oldenburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Osnabrueck
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Potsdam
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Saarbruecken
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Troisdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wiesbaden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wuppertal
country: Germany
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: