Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST) - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00054717

Purpose

Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced HIV-1 infected patients.

Condition	Intervention	Phase
HIV Infections	Drug: Tipranavir/Ritonavir	Phase III

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Open-Label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low-Dose Ritonavir (TPV/RTV) Verses Genotypically-Defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-Experienced Patients.

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir Tipranavir

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The primary endpoints are the proportion of patients with a treatment response at 48 weeks (>=1 log10 reduction in two consecutive viral load measurements without prior evidence of treatment failure) and the time to treatment failure through 48 weeks. [ Time Frame: 48 weeks ]

Secondary Outcome Measures:

Treatment emergent AIDS-defining illnesses reported in the first 48 weeks of study treatment. [ Time Frame: 24 weeks ]

Enrollment:	630
Study Start Date:	January 2003
Primary Completion Date:	September 2008 (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

Criteria

Inclusion Criteria:

Patients meeting the following criteria will be eligible for participation in this study:

HIV-1 infected males or females >=18 years of age.
Screening genotypic resistance report indicating both of the following: at least one primary PI mutation at the following sites: 30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M, and no more than two protease mutations on codons 33, 82, 84, or 90.
At least 3 consecutive months experience taking ARVs from each of the classes of NRTI(s), NNRTI(s), and PIs at some point in treatment history,with at least 2 PI-based regimens, one of which must be the current regimen, and current PI-based ARV medication regimen for at least 3 months prior to randomization.
HIV-1 viral load >=1,000 copies/mL at screening.

Exclusion Criteria:

Patients with any of the following criteria are excluded from participation in the study:

ARV medication naïve.
Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the last 3 months.
ALT >=3.0x ULN and AST >=2.5x ULN (>=DAIDS Grade 1) at either screening visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054717

Show 117 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided by Boehringer Ingelheim Pharmaceuticals

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Hicks CB, Cahn P, Cooper DA, Walmsley SL, Katlama C, Clotet B, Lazzarin A, Johnson MA, Neubacher D, Mayers D, Valdez H; RESIST investigator group. Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials. Lancet. 2006 Aug 5;368(9534):466-75.

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1182.12
Study First Received:	February 7, 2003
Last Updated:	May 28, 2009
ClinicalTrials.gov Identifier:	NCT00054717 History of Changes
Health Authority:	Australia: Responsilble Ethics Committee; Canada: Health Canada (TPD); United States: Food and Drug Administration

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Tipranavir

Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Tipranavir
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Ritonavir
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on July 02, 2009