Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients
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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 |
- The frequency of treatment emergent Adverse Events (AE) and all Serious AEs. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- Variations in laboratory from normal levels as well as changes in comparison to baseline values. Changes in the CD4 cell count from baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated 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 |
patients
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
Show 66 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00876733 History of Changes |
| Other Study ID Numbers: | 1100.1524 |
| Study First Received: | March 20, 2009 |
| Last Updated: | May 29, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Nevirapine Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013