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

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: Tipranavir (TPV); Drug: Ritonavir (RTV); Drug: Delavirdine (DLV); Drug: Zidovudine (ZDV); Drug: Lamivudine (3TC); Drug: Stavudine (d4T)

• Registration Number: NCT02249130
• Lead Sponsor: Boehringer Ingelheim

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) with and without ritonavir (RTV)

Detailed Description

Not available

Study Timeline

• Study Start: 1999-03
• Primary Completion: 2000-04
• Status Verified: 2014-09
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-23
• Last Update Submitted: 2014-09-23
• Study First Posted: 2014-09-25
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment of HIV- infected patients	Tipranavir (TPV)	14 days treatment with tipranavir, ritonavir, then 46 weeks of triple- treatment with delavirdine, zidovudine and lamivudine (stavudine for patients intolerant of zidovudine)
Treatment of HIV- infected patients	Zidovudine (ZDV)	14 days treatment with tipranavir, ritonavir, then 46 weeks of triple- treatment with delavirdine, zidovudine and lamivudine (stavudine for patients intolerant of zidovudine)
Treatment of HIV- infected patients	Stavudine (d4T)	14 days treatment with tipranavir, ritonavir, then 46 weeks of triple- treatment with delavirdine, zidovudine and lamivudine (stavudine for patients intolerant of zidovudine)
Treatment of HIV- infected patients	Ritonavir (RTV)	14 days treatment with tipranavir, ritonavir, then 46 weeks of triple- treatment with delavirdine, zidovudine and lamivudine (stavudine for patients intolerant of zidovudine)
Treatment of HIV- infected patients	Delavirdine (DLV)	14 days treatment with tipranavir, ritonavir, then 46 weeks of triple- treatment with delavirdine, zidovudine and lamivudine (stavudine for patients intolerant of zidovudine)
Treatment of HIV- infected patients	Lamivudine (3TC)	14 days treatment with tipranavir, ritonavir, then 46 weeks of triple- treatment with delavirdine, zidovudine and lamivudine (stavudine for patients intolerant of zidovudine)

Primary Outcome Measures

Name	Time	Method
Number of patients with serious treatment-emergent adverse events	Up to 46 weeks
Number of patients with drug-related adverse events	Up to 46 weeks
Number of patients with a treatment toxicity leading to study discontinuation	Up to 46 weeks
Number of patients with changes in laboratory parameters	Up to 46 weeks	Only lab values associated with metabolic disorders
Number of patients with treatment-emergent adverse events	Up to 46 weeks
Number of patients with AIDS clinical trials group (ACTG) grade 3 or 4 toxicity	Up to 46 weeks