Observational Non-interventional Study With Viramune® in Combination With Truvada® in HIV-infected Patients

NCT00543803 | Completed Results

• 1 other identifier: 1100.1492
• Study Type: observational
• Target: 334
• Locations: 1 country
• Sites: 63

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).

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (9)

• Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment

  The change in alanine aminotransferase (ALT) from baseline to the last value in treatment

  from baseline to last value on treatment in between 36 months

• Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment

  The change in asparate aminotransferase (AST) from baseline to the last value in treatment

  from baseline to last value on treatment in between 36 months

• Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment

  The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment

  from baseline to last value on treatment in between 36 months

• Summary of Change From Baseline in Creatinine to Last Value on Treatment

  The change in Creatinine from baseline to the last value in treatment

  from baseline to last value on treatment in between 36 months

• Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment

  The change in total cholesterol from baseline to the last value in treatment

  from baseline to last value on treatment in between 36 months

• Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment

  The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment

  from baseline to last value on treatment in between 36 months

• Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment

  The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment

  from baseline to last value on treatment in between 36 months

• Summary of Change From Baseline in Triglycerides to Last Value on Treatment

  The change in triglycerides from baseline to the last value in treatment

  from baseline to last value on treatment in between 36 months

• Summary of Change From Baseline in Glucose to Last Value on Treatment

  The change in Glucose from baseline to the last value in treatment

  from baseline to last value on treatment in between 36 months

Secondary Outcomes (4)

• Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment

  from baseline to last value on treatment in between 36 months

• Summary of Change From Baseline in CD4+ Count to Last Value on Treatment

  from baseline to last value on treatment in between 36 months

• Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator

  from baseline to last value on treatment in between 36 months

• Investigator's Global Clinical Assessment of Patient General Health Status

  from baseline to last value on treatment in between 36 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV Patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (63)

Boehringer Ingelheim Investigational Site

Aachen, Germany

Location

1100.1492.1 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 10

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 11

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 12

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 13

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 14

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 1

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 2

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 3

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 4

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 5

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 6

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 7

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 8

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 9

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 1

Cologne, Germany

Location

Boehringer Ingelheim Investigational Site 2

Cologne, Germany

Location

Boehringer Ingelheim Investigational Site 3

Cologne, Germany

Location

Boehringer Ingelheim Investigational Site

Dortmund, Germany

Location

Boehringer Ingelheim Investigational Site

Duisburg, Germany

Location

Boehringer Ingelheim Investigational Site 1

Düsseldorf, Germany

Location

Boehringer Ingelheim Investigational Site 2

Düsseldorf, Germany

Location

Boehringer Ingelheim Investigational Site

Frankfurt (Oder), Germany

Location

Boehringer Ingelheim Investigational Site 1

Frankfurt am Main, Germany

Location

Boehringer Ingelheim Investigational Site 2

Frankfurt am Main, Germany

Location

Boehringer Ingelheim Investigational Site 3

Frankfurt am Main, Germany

Location

Boehringer Ingelheim Investigational Site 4

Frankfurt am Main, Germany

Location

Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

Boehringer Ingelheim Investigational Site 1

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 2

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 3

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 4

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 1

Hanover, Germany

Location

Boehringer Ingelheim Investigational Site 2

Hanover, Germany

Location

Boehringer Ingelheim Investigational Site

Karlsruhe, Germany

Location

Boehringer Ingelheim Investigational Site

Koblenz, Germany

Location

Boehringer Ingelheim Investigational Site 1

Leipzig, Germany

Location

Boehringer Ingelheim Investigational Site 2

Leipzig, Germany

Location

Boehringer Ingelheim Investigational Site

Magdeburg, Germany

Location

Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

Boehringer Ingelheim Investigational Site 1

München, Germany

Location

Boehringer Ingelheim Investigational Site 2

München, Germany

Location

Boehringer Ingelheim Investigational Site 3

München, Germany

Location

Boehringer Ingelheim Investigational Site 4

München, Germany

Location

Boehringer Ingelheim Investigational Site 5

München, Germany

Location

Boehringer Ingelheim Investigational Site 1

Münster, Germany

Location

Boehringer Ingelheim Investigational Site 2

Münster, Germany

Location

Boehringer Ingelheim Investigational Site 3

Münster, Germany

Location

Boehringer Ingelheim Investigational Site 4

Münster, Germany

Location

Boehringer Ingelheim Investigational Site 1

Nuremberg, Germany

Location

Boehringer Ingelheim Investigational Site 2

Nuremberg, Germany

Location

Boehringer Ingelheim Investigational Site

Oldenburg, Germany

Location

Boehringer Ingelheim Investigational Site

Osnabrück, Germany

Location

Boehringer Ingelheim Investigational Site

Potsdam, Germany

Location

Boehringer Ingelheim Investigational Site

Saarbrücken, Germany

Location

Boehringer Ingelheim Investigational Site 1

Stuttgart, Germany

Location

Boehringer Ingelheim Investigational Site 2

Stuttgart, Germany

Location

Boehringer Ingelheim Investigational Site 3

Stuttgart, Germany

Location

Boehringer Ingelheim Investigational Site

Troisdorf, Germany

Location

Boehringer Ingelheim Investigational Site

Wiesbaden, Germany

Location

Boehringer Ingelheim Investigational Site

Wuppertal, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 8, 2007
• First Posted: October 15, 2007
• Study Start: February 1, 2006
• Primary Completion: December 1, 2009
• Last Updated: May 20, 2014
• Results First Posted: January 13, 2011

Record last verified: 2014-05

Locations

DE (63)