SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC - Full Text View

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00440271

Purpose

The primary purpose of this study is to:

Demonstrate the safety and efficacy of tipranavir/ritonavir (TPV/r) among a racially diverse HIV+ population (males and females) who are three-class (nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), and protease inhibitor (PI)) experienced with documented resistance to more than one PI.
Determine pharmacokinetic data in this racially and gender diverse population.
Determine the potential utility of using therapeutic drug monitoring (TDM) in improving efficacy outcomes.

Condition	Intervention	Phase
HIV Infections	Drug: tipranavir Drug: ritonavir	Phase III

Study Type:	Interventional
Study Design:	Treatment, Single Group Assignment, Safety/Efficacy Study
Official Title:	SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavi/r IN Race/Gender HIV+ Patients Randomized to Therapeutic Drug Monitoring or Standard of Care

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:

Treatment Response at Week 48 [ Time Frame: after 48 weeks of treatment ]

Secondary Outcome Measures:

Occurrence of Viral Load <50 Copies/mL at Each Visit Including Visits at Weeks 24 and 48 [ Time Frame: after 2 weeks of treatment ]
Occurrence of Viral Load <400 Copies/mL at Each Visit Including Visits at Weeks 24 and 48 [ Time Frame: after 2 weeks of treatment ]
Occurrence of ≥1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48 [ Time Frame: after 2 weeks of treatment ]
Change in Viral Load From Baseline at Each Visit [ Time Frame: after 2 weeks of treatment ]
Time to Treatment Failure [ Time Frame: after Day 1 of treatment ]
Time to New AIDS or AIDS Related Progression Event or Death [ Time Frame: after Day 1 of treatment ]
Change in CD4+ and CD8+ Cell Counts From Baseline at Each Visit Including Visits at Week 24 and Week 48 [ Time Frame: after 2 weeks of treatment till Week 48 ]
Change in Ratio of CD38+/CD8+ From Baseline to Week 48 [ Time Frame: after 2 weeks of treatment till Week 48 ]
TPV and RTV Trough Concentrations at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 [ Time Frame: after 2 weeks of treatment till Week 48 ]
Patients Adherence With Study Medication Based on Pill Count [ Time Frame: after 4 weeks of treatment ]
Occurrence of TPV Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured [ Time Frame: after 2 weeks of treatment ]
Occurrence of TPV Trough Concentration >120 μM [ Time Frame: after 2 weeks of treatment ]
Post-dose TPV and RTV Concentrations at Week 4 [ Time Frame: Week 4 ]

Enrollment:	33
Study Start Date:	February 2007
Primary Completion Date:	October 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:

Main inclusion criteria for the study are:

HIV-1 infected adults, men and women at least 18 years of age.
3-class (nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), and protease inhibitor (PI)) treatment-experienced (min of 3-months duration for each class) with resistance to more than one PI (on screening resistance testing). NNRTI-naïve patients who have genotypically documented NNRTI-resistance mutations on past or screening resistance testing would be eligible.
CD4+ T lymphocyte count >=50 cells/mm3.
HIV-1 viral load >=1,000 copies/mL at screening.
The antiretroviral (ARV) study treatment regimen must consist of TPV/r in combo with an optimized background regimen (OBR) of 2-4 agents: N(t)RTIs (NRTI or NtRTI), enfuvirtide (ENF), and/or, where available, a trial approved expanded access program (EAP) investigational agent.
Acceptable screening laboratory values that indicate adequate baseline organ function.
Acceptable medical history with a chest X-ray without evidence of active disease and an electrocardiogram (ECG) without clinically important abnormalities within one year of the study.
A reliable method of barrier contraception will be used by all female patients who are of childbearing potential.

Exclusion Criteria:

Main exclusion criteria for the study are:

Known hypersensitivity to the tipranavir (TPV) or ritonavir (RTV).
ARV medication naïve.
Genotypic resistance to TPV (defined as a TPV mutation score >7).
Patients on recent drug holiday, defined as off antiretroviral (ARV) medications for at least 7 consecutive days within the month prior to screening.
Prior tipranavir use.
Inability to adhere to the requirements of the protocol.
Patients with prior history of hemorrhagic stroke or intracranial aneurysm.
Patients with a history of ischemic stroke, neurosurgery or skull trauma within 4 weeks prior to screening.
History of Progressive Multifocal Leukoencephalopathy, Visceral Kaposi's Sarcoma, and/or any malignancy.
Any acquired immunodeficiency syndrome (AIDS) defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440271

Hide Study Locations

Locations

United States, District of Columbia
1182.98.033 Boehringer Ingelheim Investigational Site
Washington, District of Columbia, United States
United States, Florida
1182.98.014 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1182.98.018 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
1182.98.041 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
United States, Georgia
1182.98.004 Boehringer Ingelheim Investigational Site
Decatur, Georgia, United States
United States, Missouri
1182.98.002 Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
United States, New York
1182.98.034 Boehringer Ingelheim Investigational Site
Stony Brook, New York, United States
1182.98.016 Boehringer Ingelheim Investigational Site
New York, New York, United States
1182.98.026 Boehringer Ingelheim Investigational Site
New York, New York, United States
United States, North Carolina
1182.98.040 Boehringer Ingelheim Investigational Site
Huntersville, North Carolina, United States
United States, Ohio
1182.98.006 Boehringer Ingelheim Investigational Site
Akron, Ohio, United States
1182.98.007 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
United States, Oklahoma
1182.98.020 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
1182.98.029 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
United States, Texas
1182.98.009 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1182.98.023 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
Argentina
1182.98.5405 CENTRO de INFECTOLOGIA y ASISTENCIA (CIAS)
Capital Federal ,Buenos Aires, Argentina
1182.98.5402 Caici
Rosario, Argentina
1182.98.5403 Centro Hospital Higa - Dr Oscar Alende
Mar del Plata, Argentina
Brazil
1182.98.55004 Unidade de Referência em doenças Infecciosas Preveníveis
Santo André, Brazil
1182.98.55002 Hospital DIA
Sacomã - São Paulo, Brazil
1182.98.55003 Centro de Referência e Treinamento - DST/AIDS
Vila Mariana - Sao Paulo, Brazil
1182.98.55001 Universidade Federal de Sao Paulo
Sao Paulo, Brazil
Canada, Quebec
1182.98.1007 Boehringer Ingelheim Investigational Site
Quebec, Ste Foy, Quebec, Canada
Germany
1182.98.4903 Boehringer Ingelheim Investigational Site
Bochum, Germany
1182.98.4908 Boehringer Ingelheim Investigational Site
Hamburg, Germany
Italy
1182.98.3907 Boehringer Ingelheim Investigational Site
TORINO, Italy
Spain
1182.98.3406
Madrid, Spain
1182.98.3405
Madrid, Spain
1182.98.3402
Barcelona, Spain

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1182.98, EudraCT No.: 2005-005264-86
Study First Received:	February 26, 2007
Results First Received:	October 20, 2009
Last Updated:	October 20, 2009
ClinicalTrials.gov Identifier:	NCT00440271 History of Changes
Health Authority:	Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos Y Tecnología); Brazil: ANVISA; Canada: Therapeutic Products Directorate; Germany: Bundesinstitut für Arzneimittel und Medizinprodukte; Italy: Comitato Etico della Fondazione Centro S. Raffaele del Monte Tabor (IRCCS) - Milano; Spain:; United States: Food and Drug Administration

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 November 27, 2009