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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02191319
First Posted: July 16, 2014
Last Update Posted: July 16, 2014
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.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
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 Intervention
HIV Infections Drug: Viramune®

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change in viral load (HIV-RNA) [ Time Frame: Baseline, up to 52 weeks ]
  • Change in CD4 cell count [ Time Frame: Baseline, up to 52 weeks ]
  • Change in lipid parameters [ Time Frame: Baseline, up to 52 weeks ]
    mg/dl

  • Change in glucose [ Time Frame: Baseline, up to 52 weeks ]
    mg/dl


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

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

  • Change in liver enzyme parameter [ Time Frame: Baseline, up to 52 weeks ]
    U/l

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

Enrollment: 55
Study Start Date: January 2002
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Viramune®
Patients switching from protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) containing antiretroviral regimen to Viramune®
Drug: Viramune®

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02191319     History of Changes
Other Study ID Numbers: 1100.1395
First Submitted: July 15, 2014
First Posted: July 16, 2014
Last Update Posted: July 16, 2014
Last Verified: July 2014

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