Brief Summary

The objective of this study is to determine the long term safety and tolerability of multiple oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the development dose (500 mg tipranavir/200 mg ritonavir BID) when administered with other antiretroviral medications.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

997

participants targeted

Target at P75+ for phase_2 hiv-infections

Geographic Reach

17 countries

226 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed

4.4 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2005

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

July 16, 2009

Completed

Last Updated

March 6, 2014

Status Verified

January 1, 2014

Enrollment Period

7.1 years

First QC Date

September 5, 2005

Results QC Date

May 26, 2009

Last Update Submit

January 31, 2014

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (24)

Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - White Blood Cell ct.
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Platelets
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Prothrombin Time
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Sodium
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Potassium
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Calcium
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Phosphate
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Aspartate Aminotransferase (AST/GOT,SGOT)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alanine Aminotransferase (ALT/GPT,SGPT)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alkaline Phosphatase
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Amylase
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatine Phosphokinase
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Lipase
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Glucose
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Cholesterol, Total
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatinine
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Bilirubin, Total
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Triglycerides
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Uric Acid
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Albumin
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 -Low-density Lipoprotein (LDL)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)
Number of Patients With Adverse Events Leading to Death
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
End of Trial (>288 weeks)

Secondary Outcomes (2)

Change From Baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load - Last Observation Carried Forward (LOCF)
Baseline to 192-240 week time interval
Change From Baseline in CD4 Cell Count (LOCF)
Baseline to 192-240 week time interval

Study Arms (3)

Group 1

EXPERIMENTAL

Patients With Varying Degrees of Tipranavir Treatment Experience

Drug: Tipranavir

Group 2

EXPERIMENTAL

Highly Tipranavir Treatment Experienced Patients

Drug: Tipranavir

Group 3

EXPERIMENTAL

Tipranavir Treatment Naive Patients

Drug: Tipranavir

Interventions

TipranavirDRUG

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ability and willingness to give written informed consent in accordance with institutional and federal guidelines and to comply with the investigational nature of the study and the related requirements.
All subjects must have successfully completed participation in a combination tipranavir/ritonavir trial or have confirmed virologic failure in the 1182.12 or 1182.48 trials and are not able to obtain TPV by prescription. Successful completion of participation is defined as conclusion of required subject-weeks on assigned dosing (trial specific) and completion of required visits.
Male and female subjects 18 years and over.
Presence of Human Immunodeficiency Virus 1 (HIV-1) infection as documented by any licensed Enzyme Linked immunosorbent Assay (ELISA) test kit and confirmed by Western Blot, or HIV-1 culture, or HIV-1 antigen, or plasma HIV 1 Ribonucleic Acid (RNA) or a second antibody test by a method other than ELISA at any time prior to study entry.
Adherence to previous tipranavir/ritonavir dosing protocol and adherence to visit requirements of previous protocol (as assessed by principal investigator).
Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply:
Total Cholesterol ≤400 mg/dl (\<Common Toxicity Criteria (CTC) Grade 2).
Total Triglycerides ≤750 mg/dl (\<Division of AIDS (DAIDS) Grade 2).
Alanine aminotransferase (ALT) ≤3.0x upper limit of normal (ULN) and Aspartate aminotransferase (AST) ≤2.5x ULN (\<DAIDS Grade 1).
Any Grade Gamma Glutamyl transpeptidase(GGT) is acceptable.
Any Grade creatinine kinase is acceptable as long as there is no concurrent myopathy.
All other laboratory test values ≤DAIDS Grade 1.

You may not qualify if:

Female subjects who are of reproductive potential who:
Have a positive serum beta human chorionic gonadotropin (B HCG) at Screening/Enrollment Visit.
Are not willing to use a reliable method of barrier contraception (such as diaphragm or condoms).
Are breast-feeding.
Subjects who are actively using injection drugs or other substance abuse (such as extensive alcohol or narcotic use) which is considered by the investigator to be a significant impairment to health and to protocol adherence.
Any medical condition(s) which, in the opinion of the investigator, would interfere with the subject's ability to participate in or adhere to the requirements of this protocol.
History of any illness or drug allergy which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering tipranavir/ritonavir to the subject.
Active use of any of the following:
Investigational HIV-1 vaccines.
Any new investigational antiretroviral agent that was not approved for use in the patients prior tipranavir trial.
Medications excluded during the trial period (see Section 4.2).
Herbal medications (e.g., St. John's Wort).
Active HIV-related or non HIV-related illness that may be negatively affected by use of tipranavir/ritonavir as determined by the investigator.
If a subject must temporarily discontinue tipranavir/ritonavir at the recommendation of the investigator (at the completion of the previous tipranavir trial), then the subject may enroll in 1182.17 once the clinical illness has resolved, and after approval from the Boehringer Ingelheim Clinical Monitor or Local Clinical Monitor.
Clinically significant liver disease in the 90 days prior to baseline visit, regardless of baseline AST and/or ALT values.
+2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Boehringer Ingelheimlead

Study Sites (233)

1182.17.39 MDS Pharma Services

Phoenix, Arizona, United States

Location

1182.17.75 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

1182.17.89 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Location

1182.17.60 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

Location

1182.17.106 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1182.17.15 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1182.17.40 Tower ID Medical

Los Angeles, California, United States

Location

1182.17.46 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1182.17.47 University of Southern California

Los Angeles, California, United States

Location

1182.17.73 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1182.17.114 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1182.17.128 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1182.17.37 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Location

1182.17.58 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Location

1182.17.96 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Location

1182.17.87 Boehringer Ingelheim Investigational Site

Norwalk, Connecticut, United States

Location

1182.17.112 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Location

1182.17.43 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Location

1182.17.65 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Location

1182.17.126 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

1182.17.8 Boehringer Ingelheim Investigational Site

Fort Myers, Florida, United States

Location

1182.17.131 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1182.17.22 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1182.17.64 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

1182.17.129 Boehringer Ingelheim Investigational Site

Sarasota, Florida, United States

Location

1182.17.51 Boehringer Ingelheim Investigational Site

South Miami, Florida, United States

Location

1182.17.125 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1182.17.132 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1182.17.76 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1182.17.52 Boehringer Ingelheim Investigational Site

Vero Beach, Florida, United States

Location

1182.17.77 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

1182.17.69 Boehringer Ingelheim Investigational Site

Macon, Georgia, United States

Location

1182.17.136 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1182.17.70 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1182.17.36 Boehringer Ingelheim Investigational Site

Evanston, Illinois, United States

Location

1182.17.1 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

1182.17.32 University of Kansas School of Medicine - Wichita

Wichita, Kansas, United States

Location

1182.17.102 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Location

1182.17.21 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Location

1182.17.30 Boehringer Ingelheim Investigational Site

Portland, Maine, United States

Location

1182.17.67 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

1182.17.86 Boehringer Ingelheim Investigational Site

Bethesda, Maryland, United States

Location

1182.17.111 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

1182.17.63 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

1182.17.74 Boehringer Ingelheim Investigational Site

Springfield, Massachusetts, United States

Location

1182.17.4 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Location

1182.17.115 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Location

1182.17.6 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Location

1182.17.62 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

1182.17.59 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

1182.17.118 Early Intervention Program (EIP) Clinic

Camden, New Jersey, United States

Location

1182.17.93 Boehringer Ingelheim Investigational Site

East Orange, New Jersey, United States

Location

1182.17.24 Hackensack University Medical Center

Hackensack, New Jersey, United States

Location

1182.17.34 ID Care, Inc.

Hillsborough, New Jersey, United States

Location

1182.17.50 Boehringer Ingelheim Investigational Site

Santa Fe, New Mexico, United States

Location

1182.17.79 Boehringer Ingelheim Investigational Site

Albany, New York, United States

Location

1182.17.103 Boehringer Ingelheim Investigational Site

Mount Vernon, New York, United States

Location

1182.17.105 Pollari Medical Group