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

Tracking Information

First Received Date ^ICMJE

February 26, 2007

Last Updated Date

February 11, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00440271 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Secondary include: at least 1 log10 drop in viral load (VL) from baseline; VL <50 & <400 copies/mL; treatment failure; time to AIDS/AIDS related progression or death; pill counts;

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavi/r IN Race/Gender HIV+ Patients Randomized to Therapeutic Drug Monitoring or Standard of Care

Brief Summary

The primary purpose of this study is to:

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.
Determine pharmacokinetic data in this racially and gender diverse population.
Determine the potential utility of using therapeutic drug monitoring (TDM) in improving efficacy outcomes.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: tipranavir
Drug: ritonavir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Main inclusion criteria for the study are:

HIV-1 infected adults, men and women at least 18 years of age.
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.
CD4+ T lymphocyte count >=50 cells/mm3.
HIV-1 viral load >=1,000 copies/mL at screening.
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.
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 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 or ritonavir.
ARV medication naïve.
Genotypic resistance to TPV (defined as a TPV mutation score >7).
Patients on recent drug holiday, defined as off 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 AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Brazil, Canada, Germany, Italy, Spain

Administrative Information

NCT ID ^ICMJE

NCT00440271

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study ID Numbers ^ICMJE

1182.98, EudraCT No.: 2005-005264-86

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

February 2009

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