HIV InfectionsPhase 3NCT00517192

Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI

A Phase 3 study testing Tipranavir, Darunavir and Ritonavir in people with HIV Infections, run by Boehringer Ingelheim at 54 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: Tipranavir, Darunavir and Ritonavir
How many people: 40 participants
Where: 54 sitesin 12 countries
Study dates: Sep 2007to Sep 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent prior to trial participation.
HIV-1 infected male or female >18 years of age.
Three-class (NRTI, NNRTI, and PI) treatment-experienced patients (a minimum of 3-months duration for each class or documented class hypersensitivity/intolerance) with resistance (minimal or reduced response) to more than one PI on the screening virtual phenotype resistance testing. In the case of NNRTIs, NNRTI resistance in the absence of exposure is equivalent to being NNRTI treatment experienced.
Patient's optimized background regimen must contain one of the following ARV options:
A minimum of two genotypically active nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) reported as "maximal response" or "sensitive" on the screening virtual phenotype report.
A minimum of one genotypically active NRTI reported as "maximal response" or "sensitive" on the screening virtual phenotype report plus Enfuvirtide if not used previously.

Show all 29Show fewer

A minimum of one genotypically active NRTI reported as "maximal response" or "sensitive" on the screening virtual phenotype report plus an integrase inhibitor if not used previously and if available through an expanded access program and allowed by local regulatory authorities.
A minimum of one genotypically active NRTI reported as "maximal response" or "sensitive" on the screening virtual phenotype report plus the CCR5 chemokine receptor antagonist Maraviroc if available through an expanded access program, not used previously and allowed by local regulatory authorities.
Zero or one genotypically active NRTI reported as "maximal response" or "sensitive" on the screening virtual phenotype report plus two of the following drugs, Enfuvirtide, an integrase inhibitor and Maraviroc if available, not used previously and allowed by local regulatory authorities.
Two genotypically partially active NRTIs (provided that they are not part of the current failing regimen) reported as "reduced response" on the screening virtual phenotype report plus one of the following drugs, Enfuvirtide, an integrase inhibitor or Maraviroc if available, not used previously and allowed by local regulatory authorities.
Patient has been on their current (failing) PI-containing regimen for at least 8 weeks prior to randomization.
Patient has on-going viral replication (defined as an HIV-1 viral load of ≥ 500 copies/mL) and a successful virtual phenotype obtained at screening.
Any baseline CD4 cell count will be allowed.
Karnofsky performance score of ≥ 70.
Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered acceptable if the following apply:
ALT ≤2.5 x ULN and AST ≤2.5 x ULN (≤DAIDS Grade 1, Appendix 10.1).
Any DAIDS grade cholesterol, triglycerides, GGT, CPK or LDH is acceptable.
All other laboratory test values must be ≤DAIDS Grade 2.
Willingness to initiate CD4+ cell count-guided chemoprophylaxis to prevent opportunistic infections.
Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system during the study.
Previous use of Tipranavir (TPV) or Darunavir (DRV).
Full genotypic resistance (reported as minimal response) to Tipranavir (TPV) or Darunavir (DRV) on screening virtual phenotype:
Female patient of child-bearing potential who:
has a positive serum pregnancy test at screening, is breast feeding, is planning to become pregnant, is not willing to use double-barrier methods (simultaneous use of two different methods such as diaphragm with spermicidal substance and condom) of contraception or requires ethinyl estradiol administration. Barrier methods of contraception include diaphragm with spermicidal substance, condom for females, cervical caps and condoms.
History of Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any malignancy.
Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit.
Use of immunomodulatory drugs (such as interferon, cyclosporin, hydroxyurea and interleukin 2) within 30 days prior to randomization.
Current use of systemic cytotoxic chemotherapy.
All contraindications listed in the product monographs of Aptivus, Prezista and Norvir.

Who cannot join

None listed.

Trial locations and contacts

54 sites in 12 countries.

Country

City, postcode or hospital

54 sites in 12 countries

United States9 sites

1182.71.1109 Boehringer Ingelheim Investigational Site
Beverly Hills, California
1182.71.1126 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1182.71.1101 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1182.71.1116 Boehringer Ingelheim Investigational Site
Houston, Texas
1182.71.1118 Boehringer Ingelheim Investigational Site
Longview, Texas
1182.71.1104 Boehringer Ingelheim Investigational Site
Miami, Florida
1182.71.1115 Boehringer Ingelheim Investigational Site
Miami, Florida
1182.71.1124 Boehringer Ingelheim Investigational Site
Portland, Oregon
1182.71.1108 Boehringer Ingelheim Investigational Site
Tampa, Florida

Other trials in United States

France7 sites

1182.71.3305A Boehringer Ingelheim Investigational Site
Bondy
1182.71.3303A Boehringer Ingelheim Investigational Site
Garches
1182.71.3301A Boehringer Ingelheim Investigational Site
Lyon
1182.71.3312A Boehringer Ingelheim Investigational Site
Lyon
1182.71.3306A Boehringer Ingelheim Investigational Site
Paris
1182.71.3308A Boehringer Ingelheim Investigational Site
Paris
1182.71.3310A Boehringer Ingelheim Investigational Site
Tourcoing

Other trials in France

Italy6 sites

1182.71.3912 Boehringer Ingelheim Investigational Site
Antella (fi)
1182.71.3901 Boehringer Ingelheim Investigational Site
Brescia
1182.71.3908 Boehringer Ingelheim Investigational Site
Florence
1182.71.3916 Boehringer Ingelheim Investigational Site
Palermo
1182.71.3907 Boehringer Ingelheim Investigational Site
Pavia
1182.71.3919 Boehringer Ingelheim Investigational Site
Pescara

Other trials in Italy

Spain6 sites

1182.71.3401 Boehringer Ingelheim Investigational Site
Barcelona
1182.71.3402 Boehringer Ingelheim Investigational Site
Barcelona
1182.71.3403 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
1182.71.3405 Boehringer Ingelheim Investigational Site
Madrid
1182.71.3407 Boehringer Ingelheim Investigational Site
Madrid
1182.71.3408 Boehringer Ingelheim Investigational Site
Santiago de Compostela

Other trials in Spain

Thailand6 sites

1182.71.6604 Boehringer Ingelheim Investigational Site
Bangkok
1182.71.6601 Boehringer Ingelheim Investigational Site
Bangkok Noi
1182.71.6605 Boehringer Ingelheim Investigational Site
Chiang Mai
1182.71.6602 Boehringer Ingelheim Investigational Site
Khon Kaen
1182.71.6606 Boehringer Ingelheim Investigational Site
Nonthaburi
1182.71.6603 Boehringer Ingelheim Investigational Site
Phathumwan

Other trials in Thailand

Canada5 sites

1182.71.1003 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1182.71.1006 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1182.71.1010 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1182.71.1001 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
1182.71.1002 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

Other trials in Canada

Belgium4 sites

1182.71.3202 Boehringer Ingelheim Investigational Site
Brussels
1182.71.3203 Boehringer Ingelheim Investigational Site
Brussels
1182.71.3205 Boehringer Ingelheim Investigational Site
Brussels
1182.71.3206 Boehringer Ingelheim Investigational Site
Charleroi

Other trials in Belgium

Germany3 sites

1182.71.4902 Boehringer Ingelheim Investigational Site
Berlin
1182.71.4907 Boehringer Ingelheim Investigational Site
Frankfurt
1182.71.4903 Boehringer Ingelheim Investigational Site
Mainz

Other trials in Germany

Greece3 sites

1182.71.3002 Boehringer Ingelheim Investigational Site
Athens
1182.71.3003 Boehringer Ingelheim Investigational Site
Athens
1182.71.3001 Boehringer Ingelheim Investigational Site
Piraeus

Other trials in Greece

Portugal3 sites

1182.71.3502 Boehringer Ingelheim Investigational Site
Amadora
1182.71.3504 Boehringer Ingelheim Investigational Site
Lisbon
1182.71.3503 Boehringer Ingelheim Investigational Site
Porto

Other trials in Portugal

Puerto Rico1 site

1182.71.1129 Boehringer Ingelheim Investigational Site
Ponce

Other trials in Puerto Rico

The Bahamas1 site

1182.71.1016 Boehringer Ingelheim Investigational Site
Nassau

About this study

Official title: A Prospective, Randomized, Open-labelled, Multi-centre Trial Comparing the Safety and Efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to That of Prezista® (Darunavir, DRV/r) in Three-class (NRTI, NNRTI, and PI) Treatment-experienced Patients With Resistance to More Than One PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients

The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.

Conditions: HIV Infections
Being tested: Tipranavir, Darunavir, 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
DarunavirDrug
RitonavirDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion.
Measured: 48 weeks of treatment

Secondary outcomes (21)

Treatment Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion and the FDA Definition for Handling Drug Discontinuations ((NCF) Non-Completers=Failure).
Measured: 48 weeks of treatment
Intent-To-Treat Analysis of Virologic Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion Where Patients Are Followed Until Week 48 for VL Regardless of Whether or Not They Remain on Study Drug.
Measured: 48 weeks of treatment
Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion.
Measured: 48 weeks of treatment
Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored
Measured: up to 48 weeks
Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF
Measured: up to 48 weeks
Response up to 48 Weeks Using VL < 50 Copies/mL Using Intent-to-treat
Measured: up to 48 weeks
Response up to 48 Weeks Using VL < 400 Copies/mL Using Censored
Measured: up to 48 weeks
Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF
Measured: up to 48 weeks
Response up to 48 Weeks Using VL < 400 Copies/mL Using Intent-to-treat
Measured: up to 48 weeks
Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored
Measured: up to 48 weeks
Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using NCF
Measured: up to 48 weeks
Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat
Measured: up to 48 weeks
Daily Average in CD4+ Cell Count Change From Baseline at up to Week 8
Measured: up to week 8
Daily Average in CD4+ Cell Count Change From Baseline up to Week 24
Measured: up to week 24
Daily Average in CD4+ Cell Count Change From Baseline up to Week 48
Measured: up to week 48
Daily Average in Viral Load Change From Baseline up to Week 8
Measured: up to week 8
Daily Average in Viral Load Change From Baseline up to Week 24
Measured: up to week 24
Daily Average in Viral Load Change From Baseline up to Week 48
Measured: up to week 48
Change From Baseline in CD4+ Cell Count up to Week 48
Measured: up to week 48
Change From Baseline in log10 Viral Load up to Week 48
Measured: up to week 48
Occurrence of New AIDS Progression Events or Death
Measured: through 48 weeks of treatment

Timeline

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

Sep 2007Sep 2008

First posted16 Aug 2007 (estimated)
Study startSep 2007
Primary completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Intervention model: Parallel groups
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00517192
Sponsor's protocol ID: 1182.71
Status last verified: Apr 2014
First submitted: 15 Aug 2007
Last updated: 14 May 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Elgadi MM, Piliero PJ. Boosted tipranavir versus darunavir in treatment-experienced patients: observational data from the randomized POTENT trial. Drugs R D. 2011 Dec 1;11(4):295-302. doi: 10.2165/11596340-000000000-00000.
PubMed 22007990

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

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Open-labelled, Multi-centre Trial Comparing the Safety and Efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to That of Prezista® (Darunavir, DRV/r) in Three-class (NRTI, NNRTI, and PI) Treatment-experienced Patients With Resistance to More Than One PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients
ClinicalTrials.gov ID: NCT00517192
Acronym / sponsor ID: 1182.71
Conditions: HIV Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 40 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Sep 2008 (actual)
First posted: 16 Aug 2007 (estimated)
Results: Posted 23 Oct 2009

Clinical summary

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

Study design

Primary purpose: Treatment
Intervention model: Parallel groups

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (29 listed)

Signed informed consent prior to trial participation.
HIV-1 infected male or female >18 years of age.
Three-class (NRTI, NNRTI, and PI) treatment-experienced patients (a minimum of 3-months duration for each class or documented class hypersensitivity/intolerance) with resistance (minimal or reduced response) to more than one PI on the screening virtual phenotype resistance testing. In the case of NNRTIs, NNRTI resistance in the absence of exposure is equivalent to being NNRTI treatment experienced.
Patient's optimized background regimen must contain one of the following ARV options:
Patient has been on their current (failing) PI-containing regimen for at least 8 weeks prior to randomization.

Key exclusion criteria (0 listed)

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
Tipranavir	Drug	–
Darunavir	Drug	–
Ritonavir	Drug	–

Primary outcome

Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion.
Time frame: 48 weeks of treatment

21 secondary outcomes

Treatment Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion and the FDA Definition for Handling Drug Discontinuations ((NCF) Non-Completers=Failure).
Time frame: 48 weeks of treatment
Intent-To-Treat Analysis of Virologic Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion Where Patients Are Followed Until Week 48 for VL Regardless of Whether or Not They Remain on Study Drug.
Time frame: 48 weeks of treatment
Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion.
Time frame: 48 weeks of treatment
Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored
Time frame: up to 48 weeks
Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF
Time frame: up to 48 weeks
Response up to 48 Weeks Using VL < 50 Copies/mL Using Intent-to-treat
Time frame: up to 48 weeks
Response up to 48 Weeks Using VL < 400 Copies/mL Using Censored
Time frame: up to 48 weeks
Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF
Time frame: up to 48 weeks
Response up to 48 Weeks Using VL < 400 Copies/mL Using Intent-to-treat
Time frame: up to 48 weeks
Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored
Time frame: up to 48 weeks
Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using NCF
Time frame: up to 48 weeks
Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat
Time frame: up to 48 weeks
Daily Average in CD4+ Cell Count Change From Baseline at up to Week 8
Time frame: up to week 8
Daily Average in CD4+ Cell Count Change From Baseline up to Week 24
Time frame: up to week 24
Daily Average in CD4+ Cell Count Change From Baseline up to Week 48
Time frame: up to week 48
Daily Average in Viral Load Change From Baseline up to Week 8
Time frame: up to week 8
Daily Average in Viral Load Change From Baseline up to Week 24
Time frame: up to week 24
Daily Average in Viral Load Change From Baseline up to Week 48
Time frame: up to week 48
Change From Baseline in CD4+ Cell Count up to Week 48
Time frame: up to week 48
Change From Baseline in log10 Viral Load up to Week 48
Time frame: up to week 48
Occurrence of New AIDS Progression Events or Death
Time frame: through 48 weeks of treatment

Results and safety

Results posted to the registry on 23 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tipranavir 500 mg/Ritonavir 200 mg	19	0
Darunavir 600 mg/Ritonavir 100 mg	20	0

Primary outcome: Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion.

Time frame: 48 weeks of treatment

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the signing of the informed consent onwards through the observational phase (50 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tipranavir 500 mg/Ritonavir 200 mg	0 of 19 (0%)	12 of 19 (63.2%)	Not reported
Darunavir 600 mg/Ritonavir 100 mg	2 of 20 (10%)	7 of 20 (35%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22007990Elgadi MM, Piliero PJ. Boosted tipranavir versus darunavir in treatment-experienced patients: observational data from the randomized POTENT trial. Drugs R D. 2011 Dec 1;11(4):295-302. doi: 10.2165/11596340-000000000-00000.
Related InfoLink provided by the sponsor.

Related trials for HIV Infections

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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

54 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tipranavir, Darunavir and Ritonavir in people with HIV Infections, run by Boehringer Ingelheim at 54 sites in 12 countries.

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

Who may be eligible to take part?

The sponsor lists 29 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, France, Italy, Spain, Thailand and 7 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion. (time frame: 48 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00517192, which also lists 1 linked publication.

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 14 May 2014.