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

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Saquinavir Saquinavir mesylate Ritonavir Amprenavir Tipranavir Lopinavir

U.S. FDA Resources

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 (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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: NCT00056641

Show 109 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim

Investigators


Study Chair:	Boehringer Ingelheim Study Coordinator	Boehringer Ingelheim

More 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:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Saquinavir Amprenavir Tipranavir	Protease Inhibitors HIV Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 23, 2016