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

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00543803

First received: October 8, 2007

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 8, 2007

Last Updated Date

May 18, 2012

Start Date ^ICMJE

February 2006

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
Summary of Change From Baseline in Creatinine to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
Summary of Change From Baseline in Triglycerides to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]
Summary of Change From Baseline in Glucose to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

safety

Change History

Complete list of historical versions of study NCT00543803 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]
Summary of Log10 Change From Baseline in CD4+ Count to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Observational Non-interventional Study Evaluating the Safety and Efficacy of Truvada + Nevirapine

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

HIV Patients

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

334

Completion Date

Not Provided

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00543803

Other Study ID Numbers ^ICMJE

1100.1492

Has Data Monitoring Committee

Not Provided

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

May 2012

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

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