Clinical trial NCT02239835 (phase 2, status: terminated)
Conditions: hiv infections
ICD codes: Z21
Drugs: tipranavir (tpv) low dose, tipranavir (tpv) high dose, ritonavir low dose, ritonavir high dose, saquinavir
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Eligibility criteria:

        Inclusion Criteria:

          -  Clinical failure while on the current PI-containing regimen of indinavir, nelfinavir,
             or amprenavir

          -  In the investigator's opinion, adherence to the present PI-containing regimen

          -  Exposure of >=6 months to the current PI therapy

          -  Stable PI-containing regimen, i.e., receiving the current two reverse transcriptase
             inhibitors (RTIs) for at least 2 months prior to study entry

          -  HIV-1 RNA >=1000 copies/mL (assayed using the Amplicor polymerase chain reaction (PCR)
             method at the initial screening visit)

          -  No limit in CD4+ cell count at the initial screening

          -  At least two new nucleoside reverse transcriptase inhibitor (NRTI) options available

          -  Age >=18 years

          -  Acceptable screening laboratory test values that indicated adequate baseline organ
             function at the time of screening. Acceptable laboratory test values consisted of the
             following: severity <=Grade 1 (ACTG Grading Scale). Stable Grade 2 abnormalities were
             permitted if the values had been demonstrated and documented for at least >=2 months.
             All laboratory values >Grade 2 were subject to approval by the P&U Clinical Program
             Leader or designated personnel and subsequently by the BI designated personnel

          -  Acceptable medical history, physical examination, ECG, and chest radiograph prior to
             entry into the treatment phase of the study

          -  Use of a barrier contraceptive method of birth control for at least 30 days prior to
             study drug administration, during the study, and 30 days after study completion

          -  Ability to swallow numerous tablets and capsules without difficulty

          -  Ability to understand and provide informed consent. Minors had to have approval of a
             parent or legal guardian

        Exclusion Criteria:

          -  Treatment with more than one PI-containing regimen

          -  Clinically significant active or acute (onset within the month previous to study
             entry) medical problems, including the following: opportunistic infections, e.g.,
             active cryptococcosis, Pneumocystis carinii pneumonia, herpes zoster, histoplasmosis,
             or cytomegalovirus; nonopportunistic diseases, including but not limited to the
             following: progressive multifocal leukoencephalopathy, lymphoma, or malignancy
             requiring systemic therapy

          -  Prior exposure (>7 days) to tipranavir, saquinavir, or ritonavir

          -  History of clinically significant nervous system or muscle diseases, seizure disorder,
             or psychiatric disorder that might impair adherence to the protocol

          -  Taking of any known P450 3A enzyme-inducing drugs within 30 days of study entry and
             including the following: rifabutin, rifampin, carbamazepine, dexamethasone,
             phenobarbital, phenytoin, sulfadimidine, sulfinpyrazone, or troleandomycin

          -  Hypersensitivity to tipranavir, saquinavir, or ritonavir

          -  Use of interferons, interleukins, HIV vaccines, or any active immunizations within 30
             days of study entry

          -  Taking of any investigational medication with the exception of adefovir dipivoxil
             (Preveon™) within 30 days of study entry

          -  Pregnancy or lactation (serum β-human chorionic gonadotrophin test had to have been
             negative within 14 days of study entry)

          -  Evidence of substance abuse, which in the investigator's opinion could affect
             adherence to the protocol

          -  In the investigator's judgment, inability to comply with the protocol requirements for
             reasons other than those specified