Tipranavir Dose-response Study Using a Prototype Self-emulsifying Drug Delivery System (SEDDS) Formulation in Treatment-naive HIV-1 Infected Patients Report on the Post-study Option, a Treatment of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir

Inclusion criteria

• HIV-1 RNA ≥ 5,000 copies/mL by Roche Amplicor assay
• CD4 cell count ≥ 50 cells/mm3
• Karnofsky performance status ≥ 80
• Age ≥ 13 years
• Screening laboratory values indicative of adequate baseline organ function, Grade 0 or 1 for laboratory values based on the ACTG toxicity scale grade. Selected stable [2 months or longer] Grade 2 laboratory abnormalities were subject to sponsor's approval
• Acceptable medical history and physical examination
• Agreement to use a barrier contraceptive method for at least 1 month prior to the administration of the study medication, during the study, and for 30 days after the end of the study
• Signed informed consent
• To enter the post-study option, patients have to have completed the 14-day tipranavir phase of the trial

Exclusion criteria

• Previous treatment with any antiretroviral drugs for more than 2 weeks
• Clinically significant, active and/or acute (onset within the prior month) medical problems including opportunistic infections, such as active cryptococcosis, Pneumocystis carinii pneumonia (PCP), herpes zoster, histoplasmosis or cytomegalovirus (CMV) , or non-opportunistic diseases including, but not limited to, progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy
• History of clinically significant nervous system or muscle diseases, seizure disorder, or psychiatric disorder that might impair compliance with the study
• Receipt of any known enzyme-inducing drugs including rifabutin, rifampin, carbamazepine, dexamethasone, phenobarbital, phenytoin, sulfamidine, sulfinpyrazone, or troleandomycin within 30 days prior to participation in the study
• Receipt of any investigational medication within 30 days prior to participation in the study
• Receipt of oral contraceptives within 30 days prior to participation in the study
• Pregnancy or lactation (serum ß-human chorionic gonadotropin (ß-HCG) test negative at second screen visit of the tipranavir phase of trial)
• Evidence of active substance abuse that, in the investigator's opinion, could affect study adherence
• In the investigator's judgment, inability to comply with the protocol requirements for reasons other than those specified above