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

NCT00517192 | Terminated Phase 3 Results

• 1 other identifier: 1182.71
• Study Type: interventional
• Target: 40
• Locations: 11 countries
• Sites: 53

Brief Summary

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion.

  48 weeks of treatment

Secondary Outcomes (21)

• 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).

  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.

  48 weeks of treatment

• Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion.

  48 weeks of treatment

• Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored

  up to 48 weeks

• Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF

  up to 48 weeks

Interventions

Tipranavir DRUG

Darunavir DRUG

Ritonavir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (54)

1182.71.1109 Boehringer Ingelheim Investigational Site

Beverly Hills, California, United States

Location

1182.71.1101 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

1182.71.1104 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1182.71.1115 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1182.71.1108 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1182.71.1126 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

1182.71.1124 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

1182.71.1116 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1182.71.1118 Boehringer Ingelheim Investigational Site

Longview, Texas, United States

Location

1182.71.3202 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1182.71.3203 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1182.71.3205 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1182.71.3206 Boehringer Ingelheim Investigational Site

Charleroi, Belgium

Location

1182.71.1002 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1182.71.1001 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

1182.71.1003 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1182.71.1006 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1182.71.1010 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1182.71.3305A Boehringer Ingelheim Investigational Site

Bondy, France

Location

1182.71.3303A Boehringer Ingelheim Investigational Site

Garches, France

Location

1182.71.3301A Boehringer Ingelheim Investigational Site

Lyon, France

Location

1182.71.3312A Boehringer Ingelheim Investigational Site

Lyon, France

Location

1182.71.3306A Boehringer Ingelheim Investigational Site

Paris, France

Location

1182.71.3308A Boehringer Ingelheim Investigational Site

Paris, France

Location

1182.71.3310A Boehringer Ingelheim Investigational Site

Tourcoing, France

Location

1182.71.4902 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1182.71.4907 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

1182.71.4903 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1182.71.3002 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1182.71.3003 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1182.71.3001 Boehringer Ingelheim Investigational Site

Piraeus, Greece

Location

1182.71.3912 Boehringer Ingelheim Investigational Site

Antella (fi), Italy

Location

1182.71.3901 Boehringer Ingelheim Investigational Site

Brescia, Italy

Location

1182.71.3908 Boehringer Ingelheim Investigational Site

Florence, Italy

Location

1182.71.3916 Boehringer Ingelheim Investigational Site

Palermo, Italy

Location

1182.71.3907 Boehringer Ingelheim Investigational Site

Pavia, Italy

Location

1182.71.3919 Boehringer Ingelheim Investigational Site

Pescara, Italy

Location

1182.71.3502 Boehringer Ingelheim Investigational Site

Amadora, Portugal

Location

1182.71.3504 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1182.71.3503 Boehringer Ingelheim Investigational Site

Porto, Portugal

Location

1182.71.1129 Boehringer Ingelheim Investigational Site

Ponce, Puerto Rico

Location

1182.71.3401 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1182.71.3402 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1182.71.3403 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, Spain

Location

1182.71.3405 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1182.71.3407 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1182.71.3408 Boehringer Ingelheim Investigational Site

Santiago de Compostela, Spain

Location

1182.71.6604 Boehringer Ingelheim Investigational Site

Bangkok, Thailand

Location

1182.71.6601 Boehringer Ingelheim Investigational Site

Bangkok Noi, Thailand

Location

1182.71.6605 Boehringer Ingelheim Investigational Site

Chiang Mai, Thailand

Location

1182.71.6602 Boehringer Ingelheim Investigational Site

Khon Kaen, Thailand

Location

1182.71.6606 Boehringer Ingelheim Investigational Site

Nonthaburi, Thailand

Location

1182.71.6603 Boehringer Ingelheim Investigational Site

Phathumwan, Thailand

Location

1182.71.1016 Boehringer Ingelheim Investigational Site

Nassau, The Bahamas

Location

Related Publications (1)

• 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.

  PMID: 22007990 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

tipranavir; Darunavir; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles

Results Point of Contact

• Title: Boehringer Ingelheim Pharmaceuticals
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 16, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2008
• Last Updated: May 14, 2014
• Results First Posted: October 23, 2009

Record last verified: 2014-04

Locations

BE (4); TH (6); DE (3); CA (5); GR (3); ES (6); IT (6); FR (7); PT (3); PR (1); US (9)