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

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

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)

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

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Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
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:
Anti-Bacterial Agents
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antibiotics, Antitubercular
Antitubercular Agents
Antiviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors

ClinicalTrials.gov processed this record on May 25, 2016