SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavi/r IN Race/Gender HIV+ Patients Randomized to Therapeutic Drug Monitoring or Standard of Care
- NCT00440271
- PHASE3
- INTERVENTIONAL
Last updated: 2014-06-27
Purpose of Trial
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.
This study is for people with
HIV Infections
Interventions being studied
tipranavir
ritonavir
Optimized Background Regimen (OBR)
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.
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
16 Locations
Washington
1182.98.033 Boehringer Ingelheim Investigational Site
District of Columbia, United States
Clearwater
1182.98.018 Boehringer Ingelheim Investigational Site
Florida, United States
Fort Lauderdale
1182.98.014 Boehringer Ingelheim Investigational Site
Florida, United States
Orlando
1182.98.041 Boehringer Ingelheim Investigational Site
Florida, United States
Decatur
1182.98.004 Boehringer Ingelheim Investigational Site
Georgia, United States
Kansas City
1182.98.002 Boehringer Ingelheim Investigational Site
Missouri, United States
New York
1182.98.016 Boehringer Ingelheim Investigational Site
New York, United States
New York
1182.98.026 Boehringer Ingelheim Investigational Site
New York, United States
Stony Brook
1182.98.034 Boehringer Ingelheim Investigational Site
New York, United States
Huntersville
1182.98.040 Boehringer Ingelheim Investigational Site
North Carolina, United States
Akron
1182.98.006 Boehringer Ingelheim Investigational Site
Ohio, United States
Cincinnati
1182.98.007 Boehringer Ingelheim Investigational Site
Ohio, United States
Oklahoma City
1182.98.020 Boehringer Ingelheim Investigational Site
Oklahoma, United States
Philadelphia
1182.98.029 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Austin
1182.98.023 Boehringer Ingelheim Investigational Site
Texas, United States
Houston
1182.98.009 Boehringer Ingelheim Investigational Site
Texas, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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