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Rollover Trial Safety and Tol...

Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects

Last Updated: 2014-03-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

997 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Patients With Varying Degrees of Tipranavir Treatment Experience

Group Type EXPERIMENTAL

Tipranavir

Intervention Type DRUG

Group 2

Highly Tipranavir Treatment Experienced Patients

Group Type EXPERIMENTAL

Tipranavir

Intervention Type DRUG

Group 3

Tipranavir Treatment Naive Patients

Group Type EXPERIMENTAL

Tipranavir

Intervention Type DRUG

Interventions

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Tipranavir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. 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.
3. Male and female subjects 18 years and over.
4. 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.
5. Adherence to previous tipranavir/ritonavir dosing protocol and adherence to visit requirements of previous protocol (as assessed by principal investigator).
6. 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.

Exclusion Criteria

1. 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.
2. 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.
3. 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.
4. 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.
5. 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).
6. 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.
7. Clinically significant liver disease in the 90 days prior to baseline visit, regardless of baseline AST and/or ALT values.
8. Hypersensitivity to tipranavir or ritonavir.
9. Voluntary discontinuation of antiretroviral therapy (including tipranavir/ritonavir) for more than seven days from completion of previous tipranavir trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1182.17.77 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Site Status

1182.17.69 Boehringer Ingelheim Investigational Site

Macon, Georgia, United States

Site Status

1182.17.39 MDS Pharma Services

Phoenix, Arizona, United States

Site Status

1182.17.75 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

1182.17.89 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Site Status

1182.17.60 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

Site Status

1182.17.106 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1182.17.15 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1182.17.40 Tower ID Medical

Los Angeles, California, United States

Site Status

1182.17.46 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1182.17.47 University of Southern California

Los Angeles, California, United States

Site Status

1182.17.73 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1182.17.114 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1182.17.128 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1182.17.37 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Site Status

1182.17.58 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Site Status

1182.17.96 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Site Status

1182.17.87 Boehringer Ingelheim Investigational Site

Norwalk, Connecticut, United States

Site Status

1182.17.112 Boehringer Ingelheim Investigational Site

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

Site Status

1182.17.43 Boehringer Ingelheim Investigational Site

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

Site Status

1182.17.65 Boehringer Ingelheim Investigational Site

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

Site Status

1182.17.126 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Site Status

1182.17.8 Boehringer Ingelheim Investigational Site

Fort Myers, Florida, United States

Site Status

1182.17.131 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1182.17.22 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1182.17.64 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Site Status

1182.17.129 Boehringer Ingelheim Investigational Site

Sarasota, Florida, United States

Site Status

1182.17.51 Boehringer Ingelheim Investigational Site

South Miami, Florida, United States

Site Status

1182.17.125 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

1182.17.132 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

1182.17.76 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

1182.17.52 Boehringer Ingelheim Investigational Site

Vero Beach, Florida, United States

Site Status

1182.17.136 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1182.17.70 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1182.17.36 Boehringer Ingelheim Investigational Site

Evanston, Illinois, United States

Site Status

1182.17.1 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Site Status

1182.17.32 University of Kansas School of Medicine - Wichita

Wichita, Kansas, United States

Site Status

1182.17.102 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Site Status

1182.17.21 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Site Status

1182.17.30 Boehringer Ingelheim Investigational Site

Portland, Maine, United States

Site Status

1182.17.67 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Site Status

1182.17.86 Boehringer Ingelheim Investigational Site

Bethesda, Maryland, United States

Site Status

1182.17.111 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Site Status

1182.17.63 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Site Status

1182.17.74 Boehringer Ingelheim Investigational Site

Springfield, Massachusetts, United States

Site Status

1182.17.4 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Site Status

1182.17.115 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Site Status

1182.17.6 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Site Status

1182.17.62 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Site Status

1182.17.59 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Site Status

1182.17.118 Early Intervention Program (EIP) Clinic

Camden, New Jersey, United States

Site Status

1182.17.93 Boehringer Ingelheim Investigational Site

East Orange, New Jersey, United States

Site Status

1182.17.24 Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

1182.17.34 ID Care, Inc.

Hillsborough, New Jersey, United States

Site Status

1182.17.50 Boehringer Ingelheim Investigational Site

Santa Fe, New Mexico, United States

Site Status

1182.17.79 Boehringer Ingelheim Investigational Site

Albany, New York, United States

Site Status