Current partner codePEPTIDESDE
NCT00440271·Phase 3·INTERVENTIONAL

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

tipranavir

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.

  1. First posted

    Feb 27, 2007

  2. Study start

    Feb 2007

  3. Primary completion

    Oct 2008

  4. Study completion

    Not reported

  5. Results posted

    Nov 26, 2009

  6. 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.

Primary links

Continue at the source.

Related trials

More studies on Enfuvirtide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.