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

Stopped early · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00440271

Run by

Boehringer Ingelheim

People needed

33

Starts

2007-02-01

Last updated by the study team

2014-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.