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Observational Study With Antiretroviral Treated Patients Switching to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02191319
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : July 16, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.

Condition or disease Intervention/treatment
HIV Infections Drug: Viramune®

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study With Antiretroviral Treated Patients Switching Therapy Because of Therapeutic Reasons From Protease Inhibitor- or NNRTI-containing Regimens to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens
Study Start Date : January 2002
Actual Primary Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Nevirapine

Group/Cohort Intervention/treatment
Patients switching from protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) containing antiretroviral regimen to Viramune®
Drug: Viramune®

Primary Outcome Measures :
  1. Change in viral load (HIV-RNA) [ Time Frame: Baseline, up to 52 weeks ]
  2. Change in CD4 cell count [ Time Frame: Baseline, up to 52 weeks ]
  3. Change in lipid parameters [ Time Frame: Baseline, up to 52 weeks ]

  4. Change in glucose [ Time Frame: Baseline, up to 52 weeks ]

Secondary Outcome Measures :
  1. Assessment of subjective well-being [ Time Frame: up to 52 weeks ]
    verbal rating scale

  2. Assessment of tolerability by physician and patients [ Time Frame: after 52 weeks ]
    verbal rating scale

  3. Change in liver enzyme parameter [ Time Frame: Baseline, up to 52 weeks ]

  4. Number of patients with adverse events [ Time Frame: up to 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV treatment centres and HIV out-patient facilities

Inclusion Criteria:

  • Patients suffer from HIV type 1 infection
  • Patient is treated with antiretroviral protease-inhibitors or non-nucleoside reverse transcriptase inhibitors
  • Patient has shown a depression of viral load before limit of detection (< 50 HIV-RNA copies/ml) for more than 6 months prior to visit 1
  • Patient is male or female with age greater than or equal to 18 years
  • Women have to be willing to use an effective barrier method of contraception for the duration of the observational study participation

Exclusion Criteria:

  • Patient has clinically relevant laboratory findings (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > five times upper limit of normal (ULN))
  • Patients is hypersensitive to Viramune® or to any of its excipients
  • Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, or other drug affecting CYP3A-metabolism
  • Patients is breast-feeding
  • Patient is pregnant
  • Patient is a woman and does not use effective contraception

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Responsible Party: Boehringer Ingelheim Identifier: NCT02191319     History of Changes
Other Study ID Numbers: 1100.1395
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Anti-Retroviral Agents
Protease Inhibitors
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers