HIV InfectionsNCT00097799

Tipranavir Expanded Access Program (EAP) in PI-experienced Patients With HIV-1 Infection

A study testing Tipranavir and Ritonavir in people with HIV Infections, run by Boehringer Ingelheim at 115 sites in United States.

Approved For Marketing

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This study was designed to provide early access to and evaluate the safety of TPV/r in PI-experienced patients with HIV-1 infection. Read more about this study

Who is it for?: Any age
Conditions the study is for: HIV Infections
What is being tested?: Tipranavir and Ritonavir
How many people: Not given
Where: 115 sitesUnited States
Study dates: Dec 2004to Aug 2005
Phase: Expanded access
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Child, Adult, Older adult

Trial locations and contacts

115 sites in 1 country.

City, postcode or hospital

115 sites in 1 country

United States115 sites

1182.70.065
Anaheim, California
1182.70.011
Annadale, Virginia
1182.70.127 Health Services Center, Inc.
Anniston, Alabama
1182.70.061
Asheville, North Carolina
1182.70.002
Atlanta, Georgia
1182.70.046
Atlanta, Georgia
1182.70.069
Atlanta, Georgia
1182.70.018
Austin, Texas
1182.70.246
Baldwin Park, California
1182.70.025 Chase Brexton Health Services, Inc
Baltimore, Maryland
1182.70.004
Berkley, Michigan
1182.70.082
Boston, Massachusetts
1182.70.090
Boston, Massachusetts
1182.70.024
Briarcliff Manor, New York
1182.70.105
Bronk, New York
1182.70.100
Chapel Hill, North Carolina
1182.70.126
Charleston, South Carolina
1182.70.271
Charleston, South Carolina
1182.70.136 Mecklenburg Medical Group, P.A.
Charlotte, North Carolina
1182.70.019
Chicago, Illinois
1182.70.029 Dr. David Moore
Chicago, Illinois
1182.70.194
Chicago, Illinois
1182.70.241 University of CIncinnati Medical Center
Cincinnati, Ohio
1182.70.088
Columbia, South Carolina
1182.70.037
Dactur, Georgia
1182.70.038
Dallas, Texas
1182.70.041
Dallas, Texas
1182.70.055
Dallas, Texas
1182.70.070
Dallas, Texas
1182.70.218 Denver Infectious Disease Consultants
Denver, Colorado
1182.70.281
Denver, Colorado
1182.70.084
Detroit, Michigan
1182.70.103
Durham, North Carolina
1182.70.060
El Paso, Texas
1182.70.003
Fort Lauderdale, Florida
1182.70.013
Fort Lauderdale, Florida
1182.70.049
Fort Lauderdale, Florida
1182.70.096
Fort Lauderdale, Florida
1182.70.045
Fort Myers, Florida
1182.70.043
Fountain Valley, California
1182.70.092
Fresno, California
1182.70.057
Glendale, California
1182.70.288 Hackensack University Medical Center
Hackensack, New Jersey
1182.70.064
Harbor City, California
1182.70.026
Hollywood, Florida
1182.70.052
Houston, Texas
1182.70.054
Houston, Texas
1182.70.285
Houston, Texas
1182.70.167
Indianapolis, Indiana
1182.70.192
Iowa City, Iowa
1182.70.058
Jesup, Georgia
1182.70.010
Joliet, Illinois
1182.70.039
Kingston, New York
1182.70.021
Las Vegas, Nevada
1182.70.093
Lincoln, Nebraska
1182.70.016 Health for Life Clinic
Little Rock, Arkansas
1182.70.079
Long Beach, California
1182.70.015
Los Angeles, California
1182.70.053
Los Angeles, California
1182.70.066
Los Angeles, California
1182.70.071
Los Angeles, California
1182.70.137
Los Angeles, California
1182.70.198
Los Angeles, California
1182.70.174
Macon, Georgia
1182.70.023
Miami, Florida
1182.70.165 Comprehensive Care Center
Nashville, Tennessee
1182.70.074
New Haven, Connecticut
1182.70.099
New Orleans, Louisiana
1182.70.028
New York, New York
1182.70.031
New York, New York
1182.70.036
New York, New York
1182.70.050
New York, New York
1182.70.062
New York, New York
1182.70.104
New York, New York
1182.70.008
Newport Beach, California
1182.70.040
North Palm Beach, Florida
1182.70.073
Norwich, Connecticut
1182.70.081
Oakland, California
1182.70.095
Oakland, California
1182.70.007
Orlando, Florida
1182.70.067
Panorama City, California
1182.70.051
Philadelphia, Pennsylvania
1182.70.080
Philadelphia, Pennsylvania
1182.70.006 Spectrum Medical Group
Phoenix, Arizona
1182.70.117
Plantation, Florida
1182.70.017
Pompano Beach, Florida
1182.70.044
Portland, Oregon
1182.70.059 Fanno Creek Clinic
Portland, Oregon
1182.70.077 Kaiser Permanente-IDC
Portland, Oregon
1182.70.072
Providence, Rhode Island
1182.70.217
Richmond, Virginia
1182.70.086 Boehringer Ingelheim Investigational Site
Rochester, New York
1182.70.128 Olmos Park Medical Associates
San Antonio, Texas
1182.70.033
San Diego, California
1182.70.014
San Francisco, California
1182.70.020
San Francisco, California
1182.70.048
San Francisco, California
1182.70.085
San Francisco, California
1182.70.214
San Francisco, California
1182.70.022
San Rafael, California
1182.70.097
Seattle, Washington
1182.70.76
Seattle, Washington
1182.70.075
Sommers Point, New Jersey
1182.70.083
Spokane, Washington
1182.70.035
St Louis, Missouri
1182.70.242
St Louis, Missouri
1182.70.222
Stanford, California
1182.70.005
Tarzana, California
1182.70.030
Tarzana, California
1182.70.250 Montefiore Medical Center
The Bronx, New York
1182.70.032
Washington D.C., District of Columbia
1182.70.042
Washington D.C., District of Columbia
1182.70.289 Dupont Circle Physicians Group
Washington D.C., District of Columbia
1182.70.047
West Palm Beach, Florida
1182.70.068
Woodland Hills, California

Other trials in United States

About this study

Official title: An Open Label, Non-randomized Treatment Protocol of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Protease Inhibitor-experienced Patients With HIV-1 Infection (the Tipranavir Expanded Access Program)

This study was designed to provide early access to and evaluate the safety of TPV/r in PI-experienced patients with HIV-1 infection.

Conditions: HIV Infections
Being tested: Tipranavir, Ritonavir
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TipranavirDrug
500 mg twice daily
RitonavirDrug
200 mg twice daily

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2004Aug 2005

First posted1 Dec 2004 (estimated)
Study startDec 2004
Primary completionAug 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Expanded access

IDs, dates and publications

ClinicalTrials.gov ID: NCT00097799
Sponsor's protocol ID: 1182.70
Status last verified: Oct 2013
First submitted: 30 Nov 2004
Last updated: 30 Nov 2016
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingEarly Phase 1
A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma
Plasmablastic Lymphoma, Ann Arbor Stage I Diffuse Large B-Cell Lymphoma
Active, not recruiting
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
HIV Prevention
Not yet recruiting
Bwelela Easy Study
HIV, HIV - Human Immunodeficiency Virus
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified

All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Non-randomized Treatment Protocol of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Protease Inhibitor-experienced Patients With HIV-1 Infection (the Tipranavir Expanded Access Program)
ClinicalTrials.gov ID: NCT00097799
Acronym / sponsor ID: 1182.70
Conditions: HIV Infections
Study type: Expanded access
Recruitment status: Approved For Marketing
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Dec 2004
Primary completion: Aug 2005 (actual)
First posted: 1 Dec 2004 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study was designed to provide early access to and evaluate the safety of TPV/r in PI-experienced patients with HIV-1 infection.

Study design

Who may qualify

Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tipranavir500 mg twice daily	Drug	–
Ritonavir200 mg twice daily	Drug	–

Primary outcome

Not reported in the source record.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
Related InfoLink provided by the sponsor.

Related trials for HIV Infections

RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingEarly Phase 1
A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma
Plasmablastic Lymphoma, Ann Arbor Stage I Diffuse Large B-Cell Lymphoma
Active, not recruiting
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
HIV Prevention
Not yet recruiting
Bwelela Easy Study
HIV, HIV - Human Immunodeficiency Virus
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

115 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tipranavir and Ritonavir in people with HIV Infections, run by Boehringer Ingelheim at 115 sites in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00097799.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.