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Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00876733
First received: March 20, 2009
Last updated: January 13, 2014
Last verified: January 2014

March 20, 2009
January 13, 2014
March 2009
December 2013   (final data collection date for primary outcome measure)
The frequency of treatment emergent Adverse Events (AE) and all Serious AEs. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
The frequency of treatment emergent Adverse Events (AE) and all Serious AEs. [ Time Frame: 48 weeks ]
Complete list of historical versions of study NCT00876733 on ClinicalTrials.gov Archive Site
  • Changes in the viral load after 12 and 36 months from baseline. [ Time Frame: after 12 and 36 months ] [ Designated as safety issue: No ]
  • Changes in the CD4+ cell count after 12 and 36 months from baseline. [ Time Frame: after 12 and 36 months ] [ Designated as safety issue: No ]
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Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients
Non-Interventional Observational Study With Viramune Plus ARV in HIV Infected Patients

This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or 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 ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

patients

HIV Infections
Not Provided
HIV treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

To construct a treatment option with Viramune (nevirapine) and antiretroviral, e.g. Combivir (fixed dose combination of Zidovudine and Lamivudine), Kivexa (fixed dose combination of Abacavir and Lamivudine) or Truvada (fixed dose combination of tenofovir and emtricitabine) in male and female adult HIV type 1 infected patients, who have either not been treated previously, whose previous combination treatment with protease inhibitors has failed, or who have to switch their previous treatment from protease inhibitor or nucleosidaI reverse transcriptase inhibitor 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.

Exclusion criteria:

pAge < 18 years Pregnant female patients Hypersensitivity to the active substance or to any of the excipients of Viramune (nevirapine) or antiretroviral in combination with Viramune, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) 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 GOT (Glutamic Oxaloacetic Transaminase) or GPT (Glutamic Pyruvate Transaminase) > 5 upper limit of normal until baseline GOT/GPT are stabilised < 5 upper limit of normal.

Viramune (nevirapine) should not be readministered in patients who previously had GOT or GPT (Liver enzymes) > 5 ULN (upper limit of normal) 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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00876733
1100.1524
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
January 2014

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