Full Text View
Tabular View
Study Results
Related Studies
SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC
This study has been terminated.
Study NCT00440271   Information provided by Boehringer Ingelheim Pharmaceuticals
First Received: February 26, 2007   Last Updated: October 20, 2009   History of Changes

February 26, 2007
October 20, 2009
February 2007
October 2008   (final data collection date for primary outcome measure)
Treatment Response at Week 48 [ Time Frame: after 48 weeks of treatment ]
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.
Complete list of historical versions of study NCT00440271 on ClinicalTrials.gov Archive Site
  • 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 ]
Secondary include: at least 1 log10 drop in viral load (VL) from baseline; VL &lt;50 &amp; &lt;400 copies/mL; treatment failure; time to AIDS/AIDS related progression or death; pill counts;
 
SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC
SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavi/r IN Race/Gender HIV+ Patients Randomized to Therapeutic Drug Monitoring or Standard of Care

The primary purpose of this study is to:

  1. 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.
  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.
 
Phase III
Interventional
Treatment, Single Group Assignment, Safety/Efficacy Study
HIV Infections
  • Drug: tipranavir
  • Drug: ritonavir
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
33
 
October 2008   (final data collection date for primary outcome measure)

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 (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.
  3. CD4+ T lymphocyte count >=50 cells/mm3.
  4. HIV-1 viral load >=1,000 copies/mL at screening.
  5. 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.
  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 electrocardiogram (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 (TPV) or ritonavir (RTV).
  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 antiretroviral (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 acquired immunodeficiency syndrome (AIDS) defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Canada,   Germany,   Italy,   Spain
 
NCT00440271
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
1182.98, EudraCT No.: 2005-005264-86
Boehringer Ingelheim Pharmaceuticals
 
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP