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OpenTrials
Completed

NCT Number: NCT02191332

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

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®).

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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 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

Treatment and study plan

Viramune

Drug

Primary outcomes

  1. Change in viral load (HIV-RNA)

    Time frame: Baseline, after 26 and 52 weeks

  2. Change in CD4 cell count

    Time frame: Baseline, after 26 and 52 weeks

  3. Change in lipid status (lipodystrophy, triglycerides, cholesterol)

    Time frame: Baseline, after 26 and 52 weeks

    verbal rating scale

  4. Change in glucose tolerance

    Time frame: Baseline, after 26 and 52 weeks

    verbal rating scale

Secondary outcomes

  1. Assessment of subjective well-being

    Time frame: up to 52 weeks

    verbal rating scale

  2. Assessment of tolerability by physician and patient

    Time frame: after 26 and 52 weeks

    verbal rating scale

  3. 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

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

Important dates

Study start
1999
Primary completion
2001
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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