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

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. Identifier: NCT02191293
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : July 16, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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 or disease Intervention/treatment
HIV Infections Drug: Viramune® tablets

Study Type : Observational
Actual Enrollment : 228 participants
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)
Study Start Date : May 2002
Actual Primary Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Nevirapine

Group/Cohort Intervention/treatment
Viramune® Drug: Viramune® tablets

Primary Outcome Measures :
  1. Changes in viral load (HIV-RNA) [ Time Frame: Baseline, up to 36 months ]
  2. Changes in CD4 cell count [ Time Frame: Baseline, up to 36 months ]

Secondary Outcome Measures :
  1. Changes in body weight [ Time Frame: Baseline, up to 36 months ]
  2. Changes in general well-being assessed on a 4-point scale [ Time Frame: Baseline, up to 36 months ]
  3. Changes in lipid parameters [ Time Frame: Baseline, up to 36 months ]

  4. Changes in glucose [ Time Frame: Baseline, up to 36 months ]

  5. Changes in liver enzymes [ Time Frame: Baseline, up to 36 months ]

  6. Number of patients with adverse events [ Time Frame: up to 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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

Responsible Party: Boehringer Ingelheim Identifier: NCT02191293     History of Changes
Other Study ID Numbers: 1100.1402
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System 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