Long-term Study in Patients Under Anti-retroviral Combination Therapy Switching to Viramune®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02191293
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® tablets

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Observational Study in Patients Under Anti-retroviral Combination Therapy Who Were Switched From Protease Inhibitors or Other NNRTI to Viramune® Plus Two Nucleoside Reverse Transcriptase Inhibitors (NRTI) for Reasons of Therapy. (Long-Term Switch)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Changes in viral load (HIV-RNA) [ Time Frame: Baseline, up to 36 months ] [ Designated as safety issue: No ]
  • Changes in CD4 cell count [ Time Frame: Baseline, up to 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in body weight [ Time Frame: Baseline, up to 36 months ] [ Designated as safety issue: No ]
  • Changes in general well-being assessed on a 4-point scale [ Time Frame: Baseline, up to 36 months ] [ Designated as safety issue: No ]
  • Changes in lipid parameters [ Time Frame: Baseline, up to 36 months ] [ Designated as safety issue: No ]
    mg/dl

  • Changes in glucose [ Time Frame: Baseline, up to 36 months ] [ Designated as safety issue: No ]
    mg/dl

  • Changes in liver enzymes [ Time Frame: Baseline, up to 36 months ] [ Designated as safety issue: No ]
    U/l

  • Number of patients with adverse events [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

Enrollment: 228
Study Start Date: May 2002
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Viramune® Drug: Viramune® tablets

  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:

  • Adult male and female out-patients with HIV type 1 infection who have achieved a viral load below detection limit (50 copies/ml) for more than 6 months under a previous combination therapy with protease-inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI)
  • Women can only be included, if a test has excluded pregnancy
  • Only women can be included, who use a reliable means of contraception during the observational study

Exclusion Criteria:

  • Known sensitivity to Viramune or one of its excipients
  • Clinically relevant changes in lab findings (e.g. increase in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) by more than five-fold of upper limit normal)
  • Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, and other medication CYP3A metabolism
  • For females:

    • Pregnancy
    • Breast-feeding
    • Insufficient or unreliable 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: NCT02191293     History of Changes
Other Study ID Numbers: 1100.1402
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:
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
Reverse Transcriptase Inhibitors
Nevirapine
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on October 01, 2014