Tipranavir and Ritonavir vs. Saquinavir and Ritonavir Used With Two Nucleoside Reverse Transcriptase Inhibitors in Single Protease Inhibitor-experienced HIV-1 Patients

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

Summary

Objectives of the study were to evaluate the efficacy and safety of two different doses of tipranavir (TPV) in combination with ritonavir (TPV/r) compared with a standard dual PI combination of saquinavir (SQV) and ritonavir (RTV) and to evaluate the dose response of two different doses of TPV in combination with RTV for efficacy and safety.

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: HIV Protease Inhibitors; Protease Inhibitors; Reverse Transcriptase Inhibitors; Ritonavir; Saquinavir; Tipranavir

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