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Completed

NCT Number: NCT02191319

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Viramune®

Drug

Primary outcomes

  1. Change in viral load (HIV-RNA)

    Time frame: Baseline, up to 52 weeks

  2. Change in CD4 cell count

    Time frame: Baseline, up to 52 weeks

  3. Change in lipid parameters

    Time frame: Baseline, up to 52 weeks

    mg/dl

  4. Change in glucose

    Time frame: Baseline, up to 52 weeks

    mg/dl

Secondary outcomes

  1. Assessment of subjective well-being

    Time frame: up to 52 weeks

    verbal rating scale

  2. Assessment of tolerability by physician and patients

    Time frame: after 52 weeks

    verbal rating scale

  3. Change in liver enzyme parameter

    Time frame: Baseline, up to 52 weeks

    U/l

  4. Number of patients with adverse events

    Time frame: up to 52 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2004
First posted
Jul 16, 2014
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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