| 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 ]
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| 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; |
| |
| 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:
- 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.
- Determine pharmacokinetic data in this racially and gender diverse population.
- 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
|
| |
| |
| |
| Terminated |
| 33 |
|
| October 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
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 Criteria:
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.
|
| 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 |