Clinical trial NCT02229760 (phase 1/phase 2, status: terminated)
Conditions: hiv infections
ICD codes: Z21
Drugs: tipranavir capsules, ritonavir capsules
SMILES: [H][C@@](CC)(C1=CC(NS(=O)(=O)C2=NC=C(C=C2)C(F)(F)F)=CC=C1)C1=C(O)C[C@@](CCC)(CCC2=CC=CC=C2)OC1=O, CC(C)[C@H](NC(=O)N(C)CC1=CSC(=N1)C(C)C)C(=O)N[C@H](C[C@H](O)[C@H](CC1=CC=CC=C1)NC(=O)OCC1=CN=CS1)CC1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent before study participation

          2. Age >18 and <60 years

          3. Female patients of child-bearing potential who use a barrier contraceptive method for
             at least 12 weeks before administration of study medication, during the study and for
             28 days after administration of study medication has ended and who have a negative
             pregnancy test result

          4. Ability to swallow capsules without difficulty

          5. A Body Mass Index (BMI) between 18 and 29 kg/m2

          6. Reasonable probability of completing the study

          7. A medical history, physical examination, and electrocardiogram (ECG) before entering
             the study

          8. Agreement to abstain from alcohol from Day -2 to Day 24

          9. Agreement to abstain from ingesting grapefruit, grapefruit juice, Seville oranges or
             orange marmalade from Day -2 to Day 24

         10. Negative urine drug screen for drugs of abuse

         11. Documented HIV-1 RNA load (by PCR) at screening of <50 copies/mL for at least 3 months
             and on a stable ZDV or ABC regimen for at least 6 months. Acceptable documentation
             included laboratory data, letter, or verbal report from another provider noted in the
             patient's records

         12. All HIV-infected patients must be TPV naïve and must not have received a PI based
             regimen within 6 months of enrollment

        Exclusion Criteria:

          1. Female patients who had a positive serum pregnancy test during the screening period of
             Day -14 to Day -7 or who plan to breast-feed at time (Day 0 to 30 after TPV/r
             administration)

          2. Use of any other investigational medicine within 30 days before Day 0

          3. Use of any known CYP3A4 altering drug (i.e., phenothiazines, cimetidine, barbiturates,
             ketoconazole, fluconazole, rifampin, steroids and herbal medications) within 30 days
             before Day 0. No antibiotics were permitted within 10 days before Day 0

          4. Ingestion of grapefruit, grapefruit juice, Seville oranges, or orange marmalade within
             2 days of study entry (Day 0)

          5. Blood or plasma donations (>100 mL total) for research or altruistic reasons within 30
             days before Day 0

          6. Seated systolic blood pressure either <100 mm Hg or >150 mm Hg; resting heart rate
             either <50 beats/minute or >90 beats/minute

          7. History of any illness (including malabsorption, irregular food intake,
             gastrointestinal intolerance, or allergy) that, in the opinion of the investigator,
             might confound the results of the study or pose additional risks in administering
             TPV/r

          8. Any acute illness within 2 weeks before Day 0

          9. Patients who were currently taking any over-the-counter medication within 7 days
             before Day 0, or who were currently taking any prescription drug that, in the opinion
             of the investigator (in consultation with the BI medical monitor or
             pharmacokineticist), would have interfered with either the absorption, distribution,
             or metabolism of TPV or ritonavir

         10. Hypersensitivity to TPV, ritonavir, or sulfonamide containing drugs, or antiretroviral
             drugs (marketed or experimental use as part of clinical research studies)

         11. Sulfonamide allergy, that in the opinion of the investigator, might confound the
             results of the study or pose additional risks in administering TPV/r

         12. Any laboratory value outside the normal reference range that is of clinical relevance
             at screening, according to the judgment of the investigator (i.e., aspartate
             aminotransferase and alanine aminotransferase levels 2.5-fold and 2.5-fold higher than
             the upper normal limit, respectively)

         13. Based on the compliance diary, the patient had less than 100% documented compliance
             for 7-14 days of background Antiretroviral (ARV) (i.e., ZDV and ABC) medications
             before Day -5 to 0 (visit 2)

         14. Use of any protease inhibitors (i.e., fosamprenavir, amprenavir, indinavir,
             saquinavir, lopinavir, ritonavir, atazanavir, and nelfinavir) within 6 months of
             enrollment

         15. Patients who are co-infected with active Hepatitis B and/or C as determined by
             hepatitis serology.

         16. Use of any anti-platelet medications (e.g. aspirin, dipyridamole, clopidogrel, or any
             over the counter anti-platelet medicine).