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Observational Study in Patients With HIV Infection Type 1 After Switching to a Viramune®-Containing Therapy Regimen

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02191332
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
Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) despite switching from protease inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).

Condition Intervention
HIV Infections Drug: Viramune

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collecting Data in Patients With HIV Infection Type 1 After Switching From a Protease Inhibitor-containing Therapy Regimen and a Viral Load Below Detection Level to a Viramune®-Containing Therapy Regimen

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, after 26 and 52 weeks ]
  • Change in CD4 cell count [ Time Frame: Baseline, after 26 and 52 weeks ]
  • Change in lipid status (lipodystrophy, triglycerides, cholesterol) [ Time Frame: Baseline, after 26 and 52 weeks ]
    verbal rating scale

  • Change in glucose tolerance [ Time Frame: Baseline, after 26 and 52 weeks ]
    verbal rating scale


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

  • Assessment of tolerability by physician and patient [ Time Frame: after 26 and 52 weeks ]
    verbal rating scale

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

Enrollment: 147
Study Start Date: December 1999
Primary Completion Date: November 2001 (Final data collection date for primary outcome measure)

  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:

  • Adult male or female patients with HIV type 1 infection

Exclusion Criteria:

  • Counter-indications according to summary of product characteristics (SPC) for Viramune tablets
  • No persons under 18
  • Pregnancy and breast-feeding
  • Use of oral contraceptives
  • Use of drugs affecting CYP450 3A metabolism
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02191332     History of Changes
Other Study ID Numbers: 1100.1305
First Submitted: July 15, 2014
First Posted: July 16, 2014
Last Update Posted: July 16, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Infection
Communicable Diseases
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
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers