Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02249130
Start Date
March 1 1999
Last Update
September 25 2014
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