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

NCT ID: NCT00517192

Last Updated: 2014-05-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30

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

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Interventions

Tipranavir

Intervention Type: DRUG

Darunavir

Intervention Type: DRUG

Ritonavir

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Boehringer Ingelheim

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1182.71.1109 Boehringer Ingelheim Investigational Site

Beverly Hills, California, United States

1182.71.1101 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

1182.71.1104 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

1182.71.1115 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

1182.71.1108 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

1182.71.1126 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

1182.71.1124 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

1182.71.1116 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

1182.71.1118 Boehringer Ingelheim Investigational Site

Longview, Texas, United States

1182.71.3202 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

1182.71.3203 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

1182.71.3205 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

1182.71.3206 Boehringer Ingelheim Investigational Site

Charleroi, , Belgium

1182.71.1002 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

1182.71.1001 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

1182.71.1003 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

1182.71.1006 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

1182.71.1010 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

1182.71.3305A Boehringer Ingelheim Investigational Site

Bondy, , France

1182.71.3303A Boehringer Ingelheim Investigational Site

Garches, , France

1182.71.3301A Boehringer Ingelheim Investigational Site

Lyon, , France

1182.71.3312A Boehringer Ingelheim Investigational Site

Lyon, , France

1182.71.3306A Boehringer Ingelheim Investigational Site

Paris, , France

1182.71.3308A Boehringer Ingelheim Investigational Site

Paris, , France

1182.71.3310A Boehringer Ingelheim Investigational Site

Tourcoing, , France

1182.71.4902 Boehringer Ingelheim Investigational Site

Berlin, , Germany

1182.71.4907 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

1182.71.4903 Boehringer Ingelheim Investigational Site

Mainz, , Germany

1182.71.3002 Boehringer Ingelheim Investigational Site

Athens, , Greece

1182.71.3003 Boehringer Ingelheim Investigational Site

Athens, , Greece

1182.71.3001 Boehringer Ingelheim Investigational Site

Piraeus, , Greece

1182.71.3912 Boehringer Ingelheim Investigational Site

Antella (fi), , Italy

1182.71.3901 Boehringer Ingelheim Investigational Site

Brescia, , Italy

1182.71.3908 Boehringer Ingelheim Investigational Site

Florence, , Italy

1182.71.3916 Boehringer Ingelheim Investigational Site

Palermo, , Italy

1182.71.3907 Boehringer Ingelheim Investigational Site

Pavia, , Italy

1182.71.3919 Boehringer Ingelheim Investigational Site

Pescara, , Italy

1182.71.3502 Boehringer Ingelheim Investigational Site

Amadora, , Portugal

1182.71.3504 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

1182.71.3503 Boehringer Ingelheim Investigational Site

Porto, , Portugal

1182.71.1129 Boehringer Ingelheim Investigational Site

Ponce, , Puerto Rico

1182.71.3401 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

1182.71.3402 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

1182.71.3403 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, , Spain

1182.71.3405 Boehringer Ingelheim Investigational Site

Madrid, , Spain

1182.71.3407 Boehringer Ingelheim Investigational Site

Madrid, , Spain

1182.71.3408 Boehringer Ingelheim Investigational Site

Santiago de Compostela, , Spain

1182.71.6604 Boehringer Ingelheim Investigational Site

Bangkok, , Thailand

1182.71.6601 Boehringer Ingelheim Investigational Site

Bangkok Noi, , Thailand

1182.71.6605 Boehringer Ingelheim Investigational Site

Chiang Mai, , Thailand

1182.71.6602 Boehringer Ingelheim Investigational Site

Khon Kaen, , Thailand

1182.71.6606 Boehringer Ingelheim Investigational Site

Nonthaburi, , Thailand

1182.71.6603 Boehringer Ingelheim Investigational Site

Phathumwan, , Thailand

1182.71.1016 Boehringer Ingelheim Investigational Site

Nassau, , The Bahamas

Countries

United States; Belgium; Canada; France; Germany; Greece; Italy; Portugal; Puerto Rico; Spain; Thailand; The Bahamas

References

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.

Reference Type: DERIVED

PMID: 22007990 (View on PubMed)

Other Identifiers

1182.71

Identifier Type: -

Identifier Source: org_study_id