Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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tipranavir

Intervention Type DRUG

ritonavir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.
* Willingness to abstain from any over the counter medication 7 days prior to administration of any study medication (including vitamins, minerals, dietary supplements and antacids) during the study until completion of the post study assessments.

Exclusion Criteria

* 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.
* Inability to adhere to the protocol.
* Genotypic resistance to tipranavir (defined as a TPV mutation score \> 4).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No