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 Withou

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

Summary

To investigate the safety of a standard triple therapy regimen of delavirdine (DLV), zidovudine (ZDV), and lamivudine (3TC) following 14 days of experimental treatment with regimens of tipranavir (TPV) with and without ritonavir (RTV)

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Delavirdine; Lamivudine; Ritonavir; Stavudine; Tipranavir; Zidovudine

Criteria

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