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SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC
This study has been terminated.
First Received: February 26, 2007   Last Updated: February 11, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00440271
  Purpose

The primary purpose of this study is to:

  1. Demonstrate the safety and efficacy of TPV/r among a racially diverse HIV+ population (males and females) who are three-class (NRTI, NNRTI, and PI) experienced with documented resistance to more than one PI.
  2. Determine pharmacokinetic data in this racially and gender diverse population.
  3. 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:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Primary Outcomes: The primary efficacy endpoint is treatment response at Week 48 with a confirmed virologic response (viral load <50 copies/mL) at two consecutive measurements at least 5 days apart [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • Secondary Outcomes: drop in viral load (VL) from baseline; treatment failure; time to AIDS/AIDS related progression or death; pill counts; PK impacting TPV/r dosing with safety of adverse events and lab changes [ Time Frame: 24 and 48 weeks or as otherwise indicated in the protocol ]

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:

  1. HIV-1 infected adults, men and women at least 18 years of age.
  2. 3-class (NRTI, NNRTI, and 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.
  3. CD4+ T lymphocyte count >=50 cells/mm3.
  4. HIV-1 viral load >=1,000 copies/mL at screening.
  5. The ARV study treatment regimen must consist of TPV/r in combo with an OBR of 2-4 agents: N(t)RTIs (NRTI or NtRTI), enfuvirtide (ENF), and/or, where available, a trial approved EAP investigational agent.
  6. Acceptable screening laboratory values that indicate adequate baseline organ function.
  7. Acceptable medical history with a chest X-ray without evidence of active disease and an ECG without clinically important abnormalities within one year of the study.
  8. 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:

  1. Known hypersensitivity to the tipranavir or ritonavir.
  2. ARV medication naïve.
  3. Genotypic resistance to TPV (defined as a TPV mutation score >7).
  4. Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the month prior to screening.
  5. Prior tipranavir use.
  6. Inability to adhere to the requirements of the protocol.
  7. Patients with prior history of hemorrhagic stroke or intracranial aneurysm.
  8. Patients with a history of ischemic stroke, neurosurgery or skull trauma within 4 weeks prior to screening.
  9. History of Progressive Multifocal Leukoencephalopathy, Visceral Kaposi's Sarcoma, and/or any malignancy.
  10. Any 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

  Show 31 Study Locations
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
Last Updated: February 11, 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;   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 05, 2009