DRUG
SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC
Status
Terminated
Phase
Phase 3
Enrollment
33
Locations
30
Results
Posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
ritonavir
DRUG
Optimized Background Regimen (OBR)
Patients received between two and four active anti-retroviral medications based on resistance testing results, as background treatment, and remained on these for the duration of the trial.
Timeline
From registration to results.
First posted
Feb 27, 2007
Study start
Feb 2007
Primary completion
Oct 2008
Study completion
Not reported
Results posted
Nov 26, 2009
Registry updated
Jun 27, 2014
Outcomes
What the study measures.
Primary outcomes
Treatment Response at Week 48
Time frame · after 48 weeks of treatment
percentage of participants whose viral load \<50 copies/mL at Week 48
Secondary outcomes
Percentage of Participants Whose Viral Load <50 Copies/mL at Each Visit Including Visits at Weeks 24 and 48
Time frame · after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Percentage of Participants Whose Viral Load <400 Copies/mL at Each Visit Including Visits at Weeks 24 and 48
Time frame · after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Percentage of Participants Whose ≥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 (Weeks 2, 4, 8, 12, 24, 36, and 48)
Change in Viral Load From Baseline at Each Visit
Time frame · after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Time to Treatment Failure
Time frame · after Day 1 of treatment
For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL \>50 copies/mL at two consecutive measurements after having achieved a VL \<50 copies/mL.
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 (Weeks 2, 4, 8, 12, 24, 36, and 48)
Change in Ratio of CD38+/CD8+ From Baseline to Week 48
Time frame · after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)
Tipranavir (TPV) and Ritonavir (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 (Weeks 2, 4, 8, 12, 24, 36, and 48)
Patients Adherence With Study Medication Based on Pill Count
Time frame · after 4 weeks of treatment
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
30 registered sites.
Argentina · Brazil · Canada · Germany · Italy · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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