Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Ritonavir; Tipranavir

Criteria

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).