Back to resultsTipranavir 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
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tipranavir (TPV)
Ritonavir (RTV)
Delavirdine (DLV)
Zidovudine (ZDV)
Lamivudine (3TC)
Stavudine (d4T)
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment of HIV- infected patients
Arm Description
14 days treatment with tipranavir, ritonavir, then 46 weeks of triple- treatment with delavirdine, zidovudine and lamivudine (stavudine for patients intolerant of zidovudine)
Outcomes
Primary Outcome Measures
Number of patients with treatment-emergent adverse events
Number of patients with drug-related adverse events
Number of patients with AIDS clinical trials group (ACTG) grade 3 or 4 toxicity
Number of patients with a treatment toxicity leading to study discontinuation
Number of patients with serious treatment-emergent adverse events
Number of patients with changes in laboratory parameters
Only lab values associated with metabolic disorders
Secondary Outcome Measures
Full Information
NCT ID
NCT02249130
First Posted
September 23, 2014
Last Updated
September 23, 2014
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT02249130
Brief Title
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
Official Title
Tipranavir (PNU-140690): A Fourteen Day 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 46-week Treatment Period of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
April 2000 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment of HIV- infected patients
Arm Type
Experimental
Arm Description
14 days treatment with tipranavir, ritonavir, then 46 weeks of triple- treatment with delavirdine, zidovudine and lamivudine (stavudine for patients intolerant of zidovudine)
Intervention Type
Drug
Intervention Name(s)
Tipranavir (TPV)
Intervention Type
Drug
Intervention Name(s)
Ritonavir (RTV)
Intervention Type
Drug
Intervention Name(s)
Delavirdine (DLV)
Intervention Type
Drug
Intervention Name(s)
Zidovudine (ZDV)
Intervention Type
Drug
Intervention Name(s)
Lamivudine (3TC)
Intervention Type
Drug
Intervention Name(s)
Stavudine (d4T)
Primary Outcome Measure Information:
Title
Number of patients with treatment-emergent adverse events
Time Frame
Up to 46 weeks
Title
Number of patients with drug-related adverse events
Time Frame
Up to 46 weeks
Title
Number of patients with AIDS clinical trials group (ACTG) grade 3 or 4 toxicity
Time Frame
Up to 46 weeks
Title
Number of patients with a treatment toxicity leading to study discontinuation
Time Frame
Up to 46 weeks
Title
Number of patients with serious treatment-emergent adverse events
Time Frame
Up to 46 weeks
Title
Number of patients with changes in laboratory parameters
Description
Only lab values associated with metabolic disorders
Time Frame
Up to 46 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info
Learn more about this trial
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
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