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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.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: July 15, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
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)


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

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

Responsible Party: Boehringer Ingelheim Identifier: NCT02191332     History of Changes
Other Study ID Numbers: 1100.1305
Study First Received: July 15, 2014
Last Updated: July 15, 2014

Additional relevant MeSH terms:
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
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 processed this record on April 28, 2017