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OpenTrials
Completed

NCT Number: NCT00615290

Pharmaco-epidemiological Description of the Population Treated With Aptivus Under Market Conditions, Safety & Efficacy

To obtain information on clinical practices for patients treated by Aptivus in real life

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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

Primary location

Boehringer Ingelheim Investigational Site, Agen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HIV positive patients for whom Aptivus treatment is initiated by their physician
  • Aptivus SCP respect

Exclusion criteria

None if the inclusion criteria are respected: observational study

Treatment and study plan

Tipranavir

Drug

Primary outcomes

  1. Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3

    Time frame: 6 months after inclusion

    The evaluation at month 6 of an immunovirological response defined by a viral load less than 50 copies/mL and a gain in CD4 between day 0 and month 6 higher than 100 cells/mm3

Secondary outcomes

  1. Evaluation of Early Virological Response

    Time frame: 1 month after inclusion

    Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10

  2. Viral Load Response at 1 Month

    Time frame: 1 month after inclusion

    Please note that a reported value of "49 copies/mL" for the median or first quartile indicates that the observed statistic for the outcome measure is below the "limit of quantification" for viral load. The limit of quantification is 50 copies/mL.

  3. CD4 Count at 1 Month

    Time frame: 1 month after inclusion

  4. Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL

    Time frame: 3 months after inclusion

    Number of patients with a viral load < 400 copies/mL after 3 months of treatment

  5. Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL

    Time frame: 3 months after inclusion

    Number of patients with a viral load < 50 copies/mL after 3 months of treatment

  6. Viral Load Response at 3 Months

    Time frame: 3 months after inclusion

    Please note that a reported value of "49 copies/mL" for the median or first quartile indicates that the observed statistic for the outcome measure is below the "limit of quantification" for viral load. The limit of quantification is 50 copies/mL.

  7. CD4 Count at 3 Months

    Time frame: 3 months after inclusion

  8. Patient Self Perception of the New Treatment

    Time frame: Day 0, month 3 and month 6

    Visual analogue scale range from 0 "not at all satisfied" to 100 "extremely satisfied"

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Pharmaco-epidemiological Description of the Patient Population Treated With Aptivus Under Market Conditions, Safety & Efficacy

Important dates

Study start
2007
Primary completion
2009
First posted
Feb 14, 2008
Registry last updated
Aug 8, 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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