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Completed

NCT Number: NCT02191293

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

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

  • 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

Treatment and study plan

Viramune® tablets

Drug

Primary outcomes

  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 outcomes

  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

    mg/dl

  4. Changes in glucose

    Time frame: Baseline, up to 36 months

    mg/dl

  5. Changes in liver enzymes

    Time frame: Baseline, up to 36 months

    U/l

  6. Number of patients with adverse events

    Time frame: up to 36 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2002
Primary completion
2006
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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