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MainTitle

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

This study has been completed
Sponsor
Boehringer Ingelheim


Information provided by (Responsible Party)
Boehringer Ingelheim
ClinicalTrials.gov Identifier
NCT02249130

First received: September 23, 2014
Last updated: September 23, 2014
Last Verified: September 2014
History of Changes
Purpose

Purpose

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)

Condition Intervention Phase
HIV Infections

Drug : Tipranavir (TPV)
Drug : Ritonavir (RTV)
Drug : Delavirdine (DLV)
Drug : Zidovudine (ZDV)
Drug : Lamivudine (3TC)
Drug : Stavudine (d4T)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures

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

Enrollment: 18
Study Start Date: March 1999
Primary Completion Date: April 2000 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Treatment of HIV- infected patients
14 days treatment with tipranavir, ritonavir, then 46 weeks of triple- treatment with delavirdine, zidovudine and lamivudine (stavudine for patients intolerant of zidovudine)
Drug: Tipranavir (TPV)
Drug: Ritonavir (RTV)
Drug: Delavirdine (DLV)
Drug: Zidovudine (ZDV)
Drug: Lamivudine (3TC)
Drug: Stavudine (d4T)
Eligibility

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02249130

Sponsors and Collaborators

Boehringer Ingelheim
More Information

More Information

Additional Information:

Related Info

Responsible Party: Boehringer Ingelheim  
ClinicalTrials.gov Identifier: NCT02249130   History of Changes  
Other Study ID Numbers: 1182.3  
Study First Received: September 23, 2014  
Last Updated: September 23, 2014  

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Lamivudine
Zidovudine
Stavudine
Tipranavir
Delavirdine

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.