Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00056641
First received: March 19, 2003
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients.

The primary objective is to determine the safety and pharmacokinetics of:

TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).


Condition Intervention Phase
HIV Infections
Drug: tipranavir
Drug: ritonavir
Drug: saquinavir
Drug: amprenavir
Drug: lopinavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Parallel-group Pharmacokinetics Trial of Tipranavir / Ritonavir (TPV/RTV), Alone or in Combination With RTV-boosted Saquinavir (SQV), Amprenavir (APV), or Lopinavir (LPV), Plus an Optimized Background Regimen, in Multiple Antiretroviral (ARV) Experienced Patients.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change of the 2nd Protease Inhibitor (PI) (APV, LPV. SQV) mean concentration (C12h) [ Time Frame: Day 14 to Day 28 ] [ Designated as safety issue: No ]
  • Occurrence of adverse events; Proportion of patients with laboratory abnormalities; Proportion of patients with SAEs [ Time Frame: week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean concentration (C12h) of TPV (TPV/r group); Mean concentration (C12h) of RTV (TPV/r group) [ Time Frame: Week 1 and 2 ] [ Designated as safety issue: No ]
  • Mean concentration (C12h) of TPV (PI/TPV/r group); Mean concentration (C12h) of RTV (PI/TPV/r group) [ Time Frame: Week 3 and 4 ] [ Designated as safety issue: No ]
  • Assessment of patient adherence [ Time Frame: Week 1 to 4 ] [ Designated as safety issue: No ]
  • Area under the Curve (AUC(0-12h)) of the 2nd PI (APV, LPV. SQV); Maximum concentration (Cmax) of the 2nd PI (APV, LPV. SQV); Concentration (C12h) of the 2nd PI (APV, LPV. SQV) [ Time Frame: week 2 and 4 ] [ Designated as safety issue: No ]
  • Change in AUC(0-12h) of TPV from week 2; Change in Cmax of TPV from week 2; Change in C12h of TPV from week 2 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
  • Change in AUC(0-12h) of RTV from week 2; Change in Cmax of RTV from week 2; Change in C12h of RTV from week 2 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
  • AUC(0-12h) of RTV; Cmax of RTV; C12h of RTV [ Time Frame: week 2 and 4 ] [ Designated as safety issue: No ]
  • Change in viral load; Proportion of virologic responders [ Time Frame: week 2, 4, 8, 16 and 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 328
Study Start Date: January 2003
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00056641

  Show 109 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00056641     History of Changes
Other Study ID Numbers: 1182.51
Study First Received: March 19, 2003
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
Saquinavir
Ritonavir
Amprenavir
Lopinavir
Tipranavir
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
HIV Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents

ClinicalTrials.gov processed this record on August 27, 2014