Status:
TERMINATED
SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC
Lead Sponsor:
Boehringer Ingelheim
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 (nucle...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00440271
Start Date
February 1 2007
Last Update
June 27 2014
Active Locations (30)
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1
1182.98.033 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia, United States
2
1182.98.018 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
3
1182.98.014 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
4
1182.98.041 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States