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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02191319
First received: July 15, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  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 ] [ Designated as safety issue: No ]
  • Change in CD4 cell count [ Time Frame: Baseline, up to 52 weeks ] [ Designated as safety issue: No ]
  • Change in lipid parameters [ Time Frame: Baseline, up to 52 weeks ] [ Designated as safety issue: No ]
    mg/dl

  • Change in glucose [ Time Frame: Baseline, up to 52 weeks ] [ Designated as safety issue: No ]
    mg/dl


Secondary Outcome Measures:
  • Assessment of subjective well-being [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    verbal rating scale

  • Assessment of tolerability by physician and patients [ Time Frame: after 52 weeks ] [ Designated as safety issue: No ]
    verbal rating scale

  • Change in liver enzyme parameter [ Time Frame: Baseline, up to 52 weeks ] [ Designated as safety issue: No ]
    U/l

  • Number of patients with adverse events [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02191319     History of Changes
Other Study ID Numbers: 1100.1395
Study First Received: July 15, 2014
Last Updated: July 15, 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
HIV Protease Inhibitors
Nevirapine
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014