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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02191332
First received: July 15, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  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 ] [ Designated as safety issue: No ]
  • Change in CD4 cell count [ Time Frame: Baseline, after 26 and 52 weeks ] [ Designated as safety issue: No ]
  • Change in lipid status (lipodystrophy, triglycerides, cholesterol) [ Time Frame: Baseline, after 26 and 52 weeks ] [ Designated as safety issue: No ]
    verbal rating scale

  • Change in glucose tolerance [ Time Frame: Baseline, after 26 and 52 weeks ] [ Designated as safety issue: No ]
    verbal rating scale


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 patient [ Time Frame: after 26 and 52 weeks ] [ Designated as safety issue: No ]
    verbal rating scale

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

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

  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 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
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: NCT02191332     History of Changes
Other Study ID Numbers: 1100.1305
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:
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
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 22, 2014