A Randomised Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID in Comparison to 400 mg Lopinavir (LPV) Plus 100 mg RTV p.o. BID in Combination With Standard Background Regimen in ARV Therapy naïve Patients.

This study has been terminated.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144105
First received: September 2, 2005
Last updated: October 31, 2013
Last verified: October 2013

September 2, 2005
October 31, 2013
February 2004
November 2006   (final data collection date for primary outcome measure)
The primary endpoint is the proportion of treatment responders at 48 weeks. A treatment responder is a patient with a viral load (VL) less than 50 copies/mL measured at two consecutive visits without prior rebound or change of ARV therapy.
Same as current
Complete list of historical versions of study NCT00144105 on ClinicalTrials.gov Archive Site
Further analyses to evaluate the primary endpoint at 24, 96, and 156 weeks. Secondary endpoints include proportion of patients with VL< 400 copies/mL, change from baseline in CD4+ cell counts at each visit, time to a new CDC class C progression event.
Same as current
Not Provided
Not Provided
 
A Randomised Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID in Comparison to 400 mg Lopinavir (LPV) Plus 100 mg RTV p.o. BID in Combination With Standard Background Regimen in ARV Therapy naïve Patients.
A Randomised, Open Label, Active Controlled Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir Plus 100 mg or 200 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Comparison to 400 mg Lopinavir Plus 100 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Antiretroviral Therapy Naive Patients for 48 With Extension up to 156 Weeks

Evaluation of safety and efficacy of Tipranavir (TPV) boosted with Ritonavir (RTV) versus an active control arm (Lopinavir / RTV) in antiretroviral (ARV) therapy naïve HIV-1 infected patients

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: TPV500mg/RTV200mgBID
  • Drug: TPV500mg/RTV100mgBID
  • Drug: LPV400mg/RTV100mgBID
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
562
Not Provided
November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Signed informed consent prior to trial participation.
  2. HIV-1 infected males or females >= 18 years of age.
  3. No previous ARV therapy.
  4. Any CD4+ T lymphocyte count < 500 cells / µl.
  5. HIV-1 viral load >= 5000 copies/mL at screening.
  6. Screening laboratory values that indicate adequate baseline organ function.
  7. A prior AIDS defining event is acceptable as long as it has resolved or the subject has been on stable treatment (e.g. opportunistic infection; no ARV) for at least 2 weeks before screening

Exclusion criteria:

  1. Female patients of child-bearing potential who:

    • have a positive serum pregnancy test at screening or during the study,
    • are breast feeding,
    • are planning to become pregnant
  2. Use of investigational medications within 30 days before study entry or during the trial
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United Kingdom,   Colombia,   Canada,   Brazil,   Germany,   Argentina,   Spain,   Poland,   Russian Federation,   France,   Mexico,   Thailand,   Romania,   Bahamas
 
NCT00144105
1182.33
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Investigator: Boehringer Ingelheim Study Coordinator
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP