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
  Purpose

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).


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Observational Study With Viramune Plus ARV in HIV Infected Patients

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The frequency of treatment emergent Adverse Events (AE) and all Serious AEs. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 600
Study Start Date: March 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876733

  Show 66 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00876733     History of Changes
Other Study ID Numbers: 1100.1524
Study First Received: March 20, 2009
Last Updated: January 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014