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Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI

This study has been terminated.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00517192
First received: August 15, 2007
Last updated: April 25, 2014
Last verified: April 2014

August 15, 2007
April 25, 2014
September 2007
September 2008   (final data collection date for primary outcome measure)
Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion. [ Time Frame: 48 weeks of treatment ]
The primary endpoint of this study is time to virologic failure using VL < 50 copies/mL to determine virologic response (and VL < 500 to determine virologic rebound).
Complete list of historical versions of study NCT00517192 on ClinicalTrials.gov Archive Site
  • Treatment Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion and the FDA Definition for Handling Drug Discontinuations ((NCF) Non-Completers=Failure). [ Time Frame: 48 weeks of treatment ]
  • Intent-To-Treat Analysis of Virologic Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion Where Patients Are Followed Until Week 48 for VL Regardless of Whether or Not They Remain on Study Drug. [ Time Frame: 48 weeks of treatment ]
  • Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion. [ Time Frame: 48 weeks of treatment ]
  • Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored [ Time Frame: up to 48 weeks ]
  • Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF [ Time Frame: up to 48 weeks ]
  • Response up to 48 Weeks Using VL < 50 Copies/mL Using Intent-to-treat [ Time Frame: up to 48 weeks ]
  • Response up to 48 Weeks Using VL < 400 Copies/mL Using Censored [ Time Frame: up to 48 weeks ]
  • Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF [ Time Frame: up to 48 weeks ]
  • Response up to 48 Weeks Using VL < 400 Copies/mL Using Intent-to-treat [ Time Frame: up to 48 weeks ]
  • Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored [ Time Frame: up to 48 weeks ]
  • Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using NCF [ Time Frame: up to 48 weeks ]
  • Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat [ Time Frame: up to 48 weeks ]
  • Daily Average in CD4+ Cell Count Change From Baseline at up to Week 8 [ Time Frame: up to week 8 ]
  • Daily Average in CD4+ Cell Count Change From Baseline up to Week 24 [ Time Frame: up to week 24 ]
  • Daily Average in CD4+ Cell Count Change From Baseline up to Week 48 [ Time Frame: up to week 48 ]
  • Daily Average in Viral Load Change From Baseline up to Week 8 [ Time Frame: up to week 8 ]
  • Daily Average in Viral Load Change From Baseline up to Week 24 [ Time Frame: up to week 24 ]
  • Daily Average in Viral Load Change From Baseline up to Week 48 [ Time Frame: up to week 48 ]
  • Change From Baseline in CD4+ Cell Count up to Week 48 [ Time Frame: up to week 48 ]
  • Change From Baseline in log10 Viral Load up to Week 48 [ Time Frame: up to week 48 ]
  • Occurrence of New AIDS Progression Events or Death [ Time Frame: through 48 weeks of treatment ]
The key secondary endpoint for this study will be treatment response at week 48, using VL < 50 as the response criterion with the NonCompleters equals Failures (NCF) approach for handling patients that discontinue study drug early.
Not Provided
Not Provided
 
Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI
A Prospective, Randomized, Open-labelled, Multi-centre Trial Comparing the Safety and Efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to That of Prezista® (Darunavir, DRV/r) in Three-class (NRTI, NNRTI, and PI) Treatment-experienced Patients With Resistance to More Than One PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients

The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
HIV Infections
  • Drug: Tipranavir
  • Drug: Darunavir
  • Drug: Ritonavir
Not Provided
Elgadi MM, Piliero PJ. Boosted tipranavir versus darunavir in treatment-experienced patients: observational data from the randomized POTENT trial. Drugs R D. 2011 Dec 1;11(4):295-302. doi: 10.2165/11596340-000000000-00000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
Not Provided
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Signed informed consent prior to trial participation.
  2. HIV-1 infected male or female >18 years of age.
  3. Three-class (NRTI, NNRTI, and PI) treatment-experienced patients (a minimum of 3-months duration for each class or documented class hypersensitivity/intolerance) with resistance (minimal or reduced response) to more than one PI on the screening virtual phenotype resistance testing. In the case of NNRTIs, NNRTI resistance in the absence of exposure is equivalent to being NNRTI treatment experienced.
  4. Patient's optimized background regimen must contain one of the following ARV options:

    • A minimum of two genotypically active nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) reported as "maximal response" or "sensitive" on the screening virtual phenotype report.
    • A minimum of one genotypically active NRTI reported as "maximal response" or "sensitive" on the screening virtual phenotype report plus Enfuvirtide if not used previously.
    • A minimum of one genotypically active NRTI reported as "maximal response" or "sensitive" on the screening virtual phenotype report plus an integrase inhibitor if not used previously and if available through an expanded access program and allowed by local regulatory authorities.
    • A minimum of one genotypically active NRTI reported as "maximal response" or "sensitive" on the screening virtual phenotype report plus the CCR5 chemokine receptor antagonist Maraviroc if available through an expanded access program, not used previously and allowed by local regulatory authorities.
    • Zero or one genotypically active NRTI reported as "maximal response" or "sensitive" on the screening virtual phenotype report plus two of the following drugs, Enfuvirtide, an integrase inhibitor and Maraviroc if available, not used previously and allowed by local regulatory authorities.
    • Two genotypically partially active NRTIs (provided that they are not part of the current failing regimen) reported as "reduced response" on the screening virtual phenotype report plus one of the following drugs, Enfuvirtide, an integrase inhibitor or Maraviroc if available, not used previously and allowed by local regulatory authorities.
  5. Patient has been on their current (failing) PI-containing regimen for at least 8 weeks prior to randomization.
  6. Patient has on-going viral replication (defined as an HIV-1 viral load of ≥ 500 copies/mL) and a successful virtual phenotype obtained at screening.
  7. Any baseline CD4 cell count will be allowed.
  8. Karnofsky performance score of ≥ 70.
  9. Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered acceptable if the following apply:

    • ALT ≤2.5 x ULN and AST ≤2.5 x ULN (≤DAIDS Grade 1, Appendix 10.1).
    • Any DAIDS grade cholesterol, triglycerides, GGT, CPK or LDH is acceptable.
    • All other laboratory test values must be ≤DAIDS Grade 2.
  10. Willingness to initiate CD4+ cell count-guided chemoprophylaxis to prevent opportunistic infections.
  11. Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system during the study.

Inclusion Criteria:

  1. Previous use of Tipranavir (TPV) or Darunavir (DRV).
  2. Full genotypic resistance (reported as minimal response) to Tipranavir (TPV) or Darunavir (DRV) on screening virtual phenotype:
  3. Female patient of child-bearing potential who:

    has a positive serum pregnancy test at screening, is breast feeding, is planning to become pregnant, is not willing to use double-barrier methods (simultaneous use of two different methods such as diaphragm with spermicidal substance and condom) of contraception or requires ethinyl estradiol administration. Barrier methods of contraception include diaphragm with spermicidal substance, condom for females, cervical caps and condoms.

  4. History of Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any malignancy.
  5. Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit.
  6. Use of immunomodulatory drugs (such as interferon, cyclosporin, hydroxyurea and interleukin 2) within 30 days prior to randomization.
  7. Current use of systemic cytotoxic chemotherapy.
  8. All contraindications listed in the product monographs of Aptivus, Prezista and Norvir.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bahamas,   Belgium,   Canada,   France,   Germany,   Greece,   Italy,   Portugal,   Puerto Rico,   Spain,   Thailand
 
NCT00517192
1182.71
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

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