- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00517192
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Nassau, Bahamas
- 1182.71.1016 Boehringer Ingelheim Investigational Site
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Bruxelles, Belgium
- 1182.71.3202 Boehringer Ingelheim Investigational Site
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Bruxelles, Belgium
- 1182.71.3203 Boehringer Ingelheim Investigational Site
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Bruxelles, Belgium
- 1182.71.3205 Boehringer Ingelheim Investigational Site
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Charleroi, Belgium
- 1182.71.3206 Boehringer Ingelheim Investigational Site
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British Columbia
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Vancouver, British Columbia, Canada
- 1182.71.1002 Boehringer Ingelheim Investigational Site
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Ontario
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Ottawa, Ontario, Canada
- 1182.71.1001 Boehringer Ingelheim Investigational Site
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Quebec
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Montreal, Quebec, Canada
- 1182.71.1003 Boehringer Ingelheim Investigational Site
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Montreal, Quebec, Canada
- 1182.71.1006 Boehringer Ingelheim Investigational Site
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Montreal, Quebec, Canada
- 1182.71.1010 Boehringer Ingelheim Investigational Site
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Bondy, France
- 1182.71.3305A Boehringer Ingelheim Investigational Site
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Garches, France
- 1182.71.3303A Boehringer Ingelheim Investigational Site
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Lyon cedex, France
- 1182.71.3301A Boehringer Ingelheim Investigational Site
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Lyon cedex 3, France
- 1182.71.3312A Boehringer Ingelheim Investigational Site
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Paris, France
- 1182.71.3306A Boehringer Ingelheim Investigational Site
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Paris, France
- 1182.71.3308A Boehringer Ingelheim Investigational Site
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Tourcoing cedex, France
- 1182.71.3310A Boehringer Ingelheim Investigational Site
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Berlin, Germany
- 1182.71.4902 Boehringer Ingelheim Investigational Site
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Frankfurt, Germany
- 1182.71.4907 Boehringer Ingelheim Investigational Site
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Mainz, Germany
- 1182.71.4903 Boehringer Ingelheim Investigational Site
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Athens, Greece
- 1182.71.3002 Boehringer Ingelheim Investigational Site
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Athens, Greece
- 1182.71.3003 Boehringer Ingelheim Investigational Site
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Piraeus, Greece
- 1182.71.3001 Boehringer Ingelheim Investigational Site
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Antella (fi), Italy
- 1182.71.3912 Boehringer Ingelheim Investigational Site
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Brescia, Italy
- 1182.71.3901 Boehringer Ingelheim Investigational Site
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Firenze, Italy
- 1182.71.3908 Boehringer Ingelheim Investigational Site
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Palermo, Italy
- 1182.71.3916 Boehringer Ingelheim Investigational Site
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Pavia, Italy
- 1182.71.3907 Boehringer Ingelheim Investigational Site
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Pescara, Italy
- 1182.71.3919 Boehringer Ingelheim Investigational Site
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Amadora, Portugal
- 1182.71.3502 Boehringer Ingelheim Investigational Site
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Lisbon, Portugal
- 1182.71.3504 Boehringer Ingelheim Investigational Site
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Porto, Portugal
- 1182.71.3503 Boehringer Ingelheim Investigational Site
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Ponce, Puerto Rico
- 1182.71.1129 Boehringer Ingelheim Investigational Site
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Barcelona, Spain
- 1182.71.3401 Boehringer Ingelheim Investigational Site
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Barcelona, Spain
- 1182.71.3402 Boehringer Ingelheim Investigational Site
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L'Hospitalet de Llobregat, Spain
- 1182.71.3403 Boehringer Ingelheim Investigational Site
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Madrid, Spain
- 1182.71.3405 Boehringer Ingelheim Investigational Site
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Madrid, Spain
- 1182.71.3407 Boehringer Ingelheim Investigational Site
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Santiago de Compostela, Spain
- 1182.71.3408 Boehringer Ingelheim Investigational Site
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Bangkok, Thailand
- 1182.71.6604 Boehringer Ingelheim Investigational Site
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Bangkok Noi, Thailand
- 1182.71.6601 Boehringer Ingelheim Investigational Site
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Chiang Mai, Thailand
- 1182.71.6605 Boehringer Ingelheim Investigational Site
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Khon Kaen, Thailand
- 1182.71.6602 Boehringer Ingelheim Investigational Site
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Nonthaburi, Thailand
- 1182.71.6606 Boehringer Ingelheim Investigational Site
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Phathumwan, Thailand
- 1182.71.6603 Boehringer Ingelheim Investigational Site
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California
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Beverly Hills, California, United States
- 1182.71.1109 Boehringer Ingelheim Investigational Site
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Florida
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Ft. Lauderdale, Florida, United States
- 1182.71.1101 Boehringer Ingelheim Investigational Site
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Miami, Florida, United States
- 1182.71.1104 Boehringer Ingelheim Investigational Site
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Miami, Florida, United States
- 1182.71.1115 Boehringer Ingelheim Investigational Site
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Tampa, Florida, United States
- 1182.71.1108 Boehringer Ingelheim Investigational Site
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North Carolina
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Charlotte, North Carolina, United States
- 1182.71.1126 Boehringer Ingelheim Investigational Site
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Oregon
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Portland, Oregon, United States
- 1182.71.1124 Boehringer Ingelheim Investigational Site
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Texas
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Houston, Texas, United States
- 1182.71.1116 Boehringer Ingelheim Investigational Site
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Longview, Texas, United States
- 1182.71.1118 Boehringer Ingelheim Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed informed consent prior to trial participation.
- HIV-1 infected male or female >18 years of age.
- 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.
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.
- Patient has been on their current (failing) PI-containing regimen for at least 8 weeks prior to randomization.
- 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.
- Any baseline CD4 cell count will be allowed.
- Karnofsky performance score of ≥ 70.
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.
- Willingness to initiate CD4+ cell count-guided chemoprophylaxis to prevent opportunistic infections.
- 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:
- Previous use of Tipranavir (TPV) or Darunavir (DRV).
- Full genotypic resistance (reported as minimal response) to Tipranavir (TPV) or Darunavir (DRV) on screening virtual phenotype:
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.
- History of Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any malignancy.
- Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit.
- Use of immunomodulatory drugs (such as interferon, cyclosporin, hydroxyurea and interleukin 2) within 30 days prior to randomization.
- Current use of systemic cytotoxic chemotherapy.
- All contraindications listed in the product monographs of Aptivus, Prezista and Norvir.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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48 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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48 weeks of treatment
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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
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48 weeks of treatment
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Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion.
Time Frame: 48 weeks of treatment
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48 weeks of treatment
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Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored
Time Frame: up to 48 weeks
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up to 48 weeks
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Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF
Time Frame: up to 48 weeks
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up to 48 weeks
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Response up to 48 Weeks Using VL < 50 Copies/mL Using Intent-to-treat
Time Frame: up to 48 weeks
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up to 48 weeks
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Response up to 48 Weeks Using VL < 400 Copies/mL Using Censored
Time Frame: up to 48 weeks
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up to 48 weeks
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Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF
Time Frame: up to 48 weeks
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up to 48 weeks
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Response up to 48 Weeks Using VL < 400 Copies/mL Using Intent-to-treat
Time Frame: up to 48 weeks
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up to 48 weeks
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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
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up to 48 weeks
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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
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up to 48 weeks
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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
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up to 48 weeks
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Daily Average in CD4+ Cell Count Change From Baseline at up to Week 8
Time Frame: up to week 8
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up to week 8
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Daily Average in CD4+ Cell Count Change From Baseline up to Week 24
Time Frame: up to week 24
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up to week 24
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Daily Average in CD4+ Cell Count Change From Baseline up to Week 48
Time Frame: up to week 48
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up to week 48
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Daily Average in Viral Load Change From Baseline up to Week 8
Time Frame: up to week 8
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up to week 8
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Daily Average in Viral Load Change From Baseline up to Week 24
Time Frame: up to week 24
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up to week 24
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Daily Average in Viral Load Change From Baseline up to Week 48
Time Frame: up to week 48
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up to week 48
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Change From Baseline in CD4+ Cell Count up to Week 48
Time Frame: up to week 48
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up to week 48
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Change From Baseline in log10 Viral Load up to Week 48
Time Frame: up to week 48
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up to week 48
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Occurrence of New AIDS Progression Events or Death
Time Frame: through 48 weeks of treatment
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through 48 weeks of treatment
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
- Tipranavir
- Darunavir
Other Study ID Numbers
- 1182.71
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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