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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00440271
Other study ID # 1182.98
Secondary ID EudraCT No.: 200
Status Terminated
Phase Phase 3
First received February 26, 2007
Last updated June 17, 2014
Start date February 2007

Study information

Verified date January 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos Y Tecnología)Brazil: ANVISACanada: Therapeutic Products DirectorateGermany: Bundesinstitut für Arzneimittel und MedizinprodukteItaly: Comitato Etico della Fondazione Centro S. Raffaele del Monte Tabor (IRCCS) - MilanoSpain:United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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 (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.


Recruitment information / eligibility

Status Terminated
Enrollment 33
Est. completion date
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
tipranavir

ritonavir

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.

Locations

Country Name City State
Argentina 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
Brazil 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 Sao Paulo
Brazil 1182.98.55003 Centro de Referência e Treinamento - DST/AIDS Vila Mariana - Sao Paulo
Canada 1182.98.1007 Boehringer Ingelheim Investigational Site Quebec, Ste Foy Quebec
Germany 1182.98.4903 Boehringer Ingelheim Investigational Site Bochum
Germany 1182.98.4908 Boehringer Ingelheim Investigational Site Hamburg
Italy 1182.98.3907 Boehringer Ingelheim Investigational Site Torino
Spain 1182.98.3402 Barcelona
Spain 1182.98.3405 Madrid
Spain 1182.98.3406 Madrid
United States 1182.98.006 Boehringer Ingelheim Investigational Site Akron Ohio
United States 1182.98.023 Boehringer Ingelheim Investigational Site Austin Texas
United States 1182.98.007 Boehringer Ingelheim Investigational Site Cincinnati Ohio
United States 1182.98.018 Boehringer Ingelheim Investigational Site Clearwater Florida
United States 1182.98.004 Boehringer Ingelheim Investigational Site Decatur Georgia
United States 1182.98.014 Boehringer Ingelheim Investigational Site Fort Lauderdale Florida
United States 1182.98.009 Boehringer Ingelheim Investigational Site Houston Texas
United States 1182.98.040 Boehringer Ingelheim Investigational Site Huntersville North Carolina
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 1182.98.020 Boehringer Ingelheim Investigational Site Oklahoma City Oklahoma
United States 1182.98.041 Boehringer Ingelheim Investigational Site Orlando Florida
United States 1182.98.029 Boehringer Ingelheim Investigational Site Philadelphia Pennsylvania
United States 1182.98.034 Boehringer Ingelheim Investigational Site Stony Brook New York
United States 1182.98.033 Boehringer Ingelheim Investigational Site Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Germany,  Italy,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment Response at Week 48 percentage of participants whose viral load <50 copies/mL at Week 48 after 48 weeks of treatment No
Secondary Percentage of Participants Whose Viral Load <50 Copies/mL at Each Visit Including Visits at Weeks 24 and 48 after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48) No
Secondary Percentage of Participants Whose Viral Load <400 Copies/mL at Each Visit Including Visits at Weeks 24 and 48 after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48) No
Secondary Percentage of Participants Whose =1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48 after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48) No
Secondary Change in Viral Load From Baseline at Each Visit after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48) No
Secondary Time to Treatment Failure 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. after Day 1 of treatment No
Secondary Time to New AIDS or AIDS Related Progression Event or Death after Day 1 of treatment No
Secondary Change in CD4+ and CD8+ Cell Counts From Baseline at Each Visit Including Visits at Week 24 and Week 48 after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48) No
Secondary Change in Ratio of CD38+/CD8+ From Baseline to Week 48 after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48) No
Secondary Tipranavir (TPV) and Ritonavir (RTV) Trough Concentrations at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48 after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48) No
Secondary Patients Adherence With Study Medication Based on Pill Count after 4 weeks of treatment No
Secondary Occurrence of TPV Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48) No
Secondary Occurrence of TPV Trough Concentration >120 µM after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48) No
Secondary Post-dose TPV and RTV Concentrations at Week 4 Week 4 No
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