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Completed

NCT Number: NCT00531206

Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.

This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Aptivus (tipranavir) in combination with low-dose Norvir (ritonavir) will durably suppress viral load and may achieve suppression of viral load below the limit of detection.

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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, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Highly pre-treated male and female adult patients with virus resistant to multiple protease inhibitors. Aptivus (tipranavir), co-administered with low dose Norvir (ritonavir), is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.

Exclusion criteria

  • Age < 18 years
  • pregnant female patients
  • Hypersensitivity to the active substance or to any of the excipients.
  • Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.
  • Rifampicin should not be used with Aptivus (tipranavir) because co-administration may cause large decreases in tipranavir concentrations which may in turn significantly decrease the tipranavir therapeutic effect.
  • Herbal preparations containing St John's wort must not be used while taking Aptivus (tipranavir) due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir.
  • Co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. These active substances include antiarrhythmics (amiodarone, bepridil, quinidine), antihistamines (astemizole, terfenadine), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/hypnotics (triazolam) and HMG-CoA reductase inhibitors (simvastatin and lovastatin). In addition, co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with drugs that are highly dependent on CYP2D6 for clearance, such as the antiarrhythmics flecainide and propafenone, is contraindicated.

Treatment and study plan

Tipranavir

Drug

Ritonavir

Drug

low dose

Primary outcomes

  1. Adverse Events

    Time frame: 52 weeks

    The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.

Secondary outcomes

  1. Change in Viral Load

    Time frame: Baseline and 52 weeks

    Log10 change from baseline in viral load over time

  2. CD4+ Cell Count

    Time frame: Baseline and 52 weeks

    Change from baseline in CD4+ count over time

  3. Subjective Well-being

    Time frame: 52 weeks

    Investigator's opinion of patient's general condition (quality of life)

  4. Serious Adverse Events

    Time frame: 52 weeks

    The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.

  5. Deaths

    Time frame: 52 weeks

    The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.

  6. Discontinuations Due to an Adverse Event

    Time frame: 52 weeks

    The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.

  7. Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion

    Time frame: 52 weeks

    The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.

  8. Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir

    Time frame: 52 weeks

  9. Use of Lipid Lowering Agents During the Study

    Time frame: 52 weeks

  10. Body Mass Index Class (Kilograms/Square Meter)

    Time frame: 52 weeks

  11. Total Cholesterol Over Time

    Time frame: 52 weeks

  12. High Density Lipoprotein (HDL) Cholesterol Over Time

    Time frame: 52 weeks

  13. Low Density Lipoprotein (HDL) Cholesterol Over Time

    Time frame: 52 weeks

  14. Triglycerides Over Time

    Time frame: 52 weeks

  15. Alanine Aminotransferase (ALT) Over Time

    Time frame: 52 weeks

  16. Aspartate Aminotransferase (ALT) Over Time

    Time frame: 52 weeks

  17. Gamma-glutamyl Transpeptidase (GGT) Over Time

    Time frame: 52 weeks

  18. Creatinine Over Time

    Time frame: 52 weeks

  19. Total Bilirubin Over Time

    Time frame: 52 weeks

  20. Alkaline Phosphatase Over Time

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Observational Non-interventional Study About Antiretroviral Combination Treatment With Aptivus in Combination With Low-dose Ritonavir in HIV Type 1 Infected Patients

Important dates

Study start
2006
Primary completion
2009
First posted
Sep 18, 2007
Registry last updated
Apr 7, 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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