Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients

NCT00530920 | Completed Phase 2 Results

• 1 other identifier: 1182.107
• Study Type: interventional
• Target: 85
• Locations: 3 countries
• Sites: 12

Brief Summary

The purpose of this study is to identify an optimal dose combination(s) of tipranavir (TPV) and ritonavir (RTV) for antiretroviral treatment naïve HIV-1 infected patients that can be used in pivotal trial by assessing the steady-state pharmacokinetics and short-term efficacy and safety

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))

  Baseline (Day 0) to Final (Day 14)

Secondary Outcomes (16)

• Apparent Oral Clearance I(Cl/F) of Tipranavir

  Final (Day 14)

• Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID)

  Final (Day 13 for QD, Day 14 for BID)

• Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID

  Final (Day 13 for QD, Day 14 for BID)

• Trough Concentration (Cmin) of Tipranavir

  Final (Day 13 for QD, Day 14 for BID)

• Maximum Concentration (Cmax) of Tipranavir

  Final (Day 13 for QD, Day 14 for BID)

Interventions

tipranavir DRUG

ritonavir DRUG

Eligibility Criteria

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

You may qualify if:

• Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation.
• HIV-1 infected men and non-pregnant women who are treatment naïve, with positive serology (EIA) confirmed by Western blot.
• Age \> 18 and \< 65 years.
• CD4 \> 200 cells/mm3
• Viral load (HIV-1 mRNA viral load) \> 5,000 copies/mL.
• Ability to swallow multiple large capsules without difficulty.
• Acceptable laboratory values that indicate adequate baseline organ function at screening visit.
• Laboratory values are considered to be acceptable if the severity of any parameter is = \< Grade 2, based on the DAIDS/ACTG Grading Scale (see Appendix 10.2).
• Acceptable medical history, physical examination, and 12-lead ECG at screening
• Willingness to abstain from the following starting 2 weeks prior to administration of any study medication and up until the end of the study:
• o Grapefruit or grapefruit juice, Seville oranges, St. John's Wort, and Milk Thistle.
• Willingness to abstain from alcohol 3 days prior to administration of any study medication up to the end of the study.
• Willingness to abstain from the following starting 3 days prior to PK sampling:
• o Garlic supplements and methylxanthine containing foods or drinks (including coffee, tea, cola, energy drinks, chocolate, etc.).
• Willingness to abstain from over-the-counter herbal medications for the duration of the study.

You may not qualify if:

• Female patients of reproductive potential who:
• Have positive serum pregnancy test.
• Have not been using a barrier method of contraception for at least 3 months prior to participation in the study.
• Are not willing to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and 60 days after completion/termination of the trial.
• Are breast-feeding.
• Suspected or documented seroconversion within last 6 months
• Participation in another trial with an investigational medicine within 2 months prior to Day 0 of this study.
• Use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month prior to Day 0 and for the duration of the study.
• Use of hormone replacement therapy within 1 month prior to Day 0 and anytime during the study.
• History of acute illness within 30 days prior to Day 0.
• Have evidence of active or acute HBV or HCV.
• Alcohol or substance abuse within 1 year prior to screening or during the study.
• Patients with a history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering TPV.
• Patients who have taken (within 7 days prior to Day 0) any over-the-counter or prescription medication that, in the opinion of the investigator in consultation with the BI clinical monitor, might interfere with absorption, distribution, or metabolism of the study medications.
• Known hypersensitivity to any ingredients of the test drug.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (12)

1182.107.49002 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1182.107.49004 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1182.107.49003 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

1182.107.49001 Boehringer Ingelheim Investigational Site

München, Germany

Location

1182.107.39001 Boehringer Ingelheim Investigational Site

Antella (fi), Italy

Location

1182.107.39009 Boehringer Ingelheim Investigational Site

Bari, Italy

Location

1182.107.39007 Boehringer Ingelheim Investigational Site

Ferrara, Italy

Location

1182.107.39011 Boehringer Ingelheim Investigational Site

Palermo, Italy

Location

1182.107.34001 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1182.107.34002 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1182.107.34003 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, Spain

Location

1182.107.34004 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

tipranavir; 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)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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 2
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2007
• First Posted: September 18, 2007
• Study Start: October 1, 2007
• Primary Completion: May 1, 2008
• Last Updated: June 6, 2014
• Results First Posted: July 8, 2009

Record last verified: 2014-05

Locations

DE (4); ES (4); IT (4)