HIV InfectionsPhase 2NCT00530920

Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients

A Phase 2 study testing tipranavir and ritonavir in people with HIV Infections, run by Boehringer Ingelheim at 12 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to identify an optimal dose combination(s) of tipranavir (TPV) and ritonavir (RTV) for antiretroviral treatment naïve HIV-1 infected patients that can be used in pivotal trial by assessing the steady-state pharmacokinetics and short-term efficacy and safety Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: HIV Infections
What is being tested?: tipranavir and ritonavir
How many people: 85 participants
Where: 12 sitesin 3 countries
Study dates: Oct 2007to May 2008
Phase: Phase 2
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation.
HIV-1 infected men and non-pregnant women who are treatment naïve, with positive serology (EIA) confirmed by Western blot.
Age > 18 and < 65 years.
CD4 > 200 cells/mm3
Viral load (HIV-1 mRNA viral load) > 5,000 copies/mL.
Ability to swallow multiple large capsules without difficulty.

Show all 16Show fewer

Acceptable laboratory values that indicate adequate baseline organ function at screening visit.
Laboratory values are considered to be acceptable if the severity of any parameter is = < Grade 2, based on the DAIDS/ACTG Grading Scale (see Appendix 10.2).
Acceptable medical history, physical examination, and 12-lead ECG at screening
Willingness to abstain from the following starting 2 weeks prior to administration of any study medication and up until the end of the study:
o Grapefruit or grapefruit juice, Seville oranges, St. John's Wort, and Milk Thistle.
Willingness to abstain from alcohol 3 days prior to administration of any study medication up to the end of the study.
Willingness to abstain from the following starting 3 days prior to PK sampling:
o Garlic supplements and methylxanthine containing foods or drinks (including coffee, tea, cola, energy drinks, chocolate, etc.).
Willingness to abstain from over-the-counter herbal medications for the duration of the study.
Willingness to abstain from any over the counter medication 7 days prior to administration of any study medication (including vitamins, minerals, dietary supplements and antacids) during the study until completion of the post study assessments.

Who cannot join

Female patients of reproductive potential who:
Have positive serum pregnancy test.
Have not been using a barrier method of contraception for at least 3 months prior to participation in the study.
Are not willing to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and 60 days after completion/termination of the trial.
Are breast-feeding.
Suspected or documented seroconversion within last 6 months

Show all 17Show fewer

Participation in another trial with an investigational medicine within 2 months prior to Day 0 of this study.
Use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month prior to Day 0 and for the duration of the study.
Use of hormone replacement therapy within 1 month prior to Day 0 and anytime during the study.
History of acute illness within 30 days prior to Day 0.
Have evidence of active or acute HBV or HCV.
Alcohol or substance abuse within 1 year prior to screening or during the study.
Patients with a history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering TPV.
Patients who have taken (within 7 days prior to Day 0) any over-the-counter or prescription medication that, in the opinion of the investigator in consultation with the BI clinical monitor, might interfere with absorption, distribution, or metabolism of the study medications.
Known hypersensitivity to any ingredients of the test drug.
Inability to adhere to the protocol.
Genotypic resistance to tipranavir (defined as a TPV mutation score > 4).

Trial locations and contacts

12 sites in 3 countries.

Country

City, postcode or hospital

12 sites in 3 countries

Germany4 sites

1182.107.49002 Boehringer Ingelheim Investigational Site
Berlin
1182.107.49004 Boehringer Ingelheim Investigational Site
Berlin
1182.107.49003 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1182.107.49001 Boehringer Ingelheim Investigational Site
München

Other trials in Germany

Italy4 sites

1182.107.39001 Boehringer Ingelheim Investigational Site
Antella (fi)
1182.107.39009 Boehringer Ingelheim Investigational Site
Bari
1182.107.39007 Boehringer Ingelheim Investigational Site
Ferrara
1182.107.39011 Boehringer Ingelheim Investigational Site
Palermo

Other trials in Italy

Spain4 sites

1182.107.34001 Boehringer Ingelheim Investigational Site
Barcelona
1182.107.34002 Boehringer Ingelheim Investigational Site
Barcelona
1182.107.34003 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
1182.107.34004 Boehringer Ingelheim Investigational Site
Madrid

Other trials in Spain

About this study

Official title: A Multicenter, Randomized, Open Label, Clinical Trial to Evaluate Three Doses of Tipranavir Boosted With Ritonavir (500 mg/200 mg qd, 250 mg/100 mg Bid and 500 mg/100 mg Bid) by Assessing the Steady-state Pharmacokinetics and Short-term Efficacy and Safety in HIV-1 Positive Treatment naïve Patients

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
ritonavirDrug

What is being measured

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

Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))
Measured: Baseline (Day 0) to Final (Day 14)

Secondary outcomes (16)

Apparent Oral Clearance I(Cl/F) of Tipranavir
Tipranavir pharmacokinetics - Clearance (CL) is defined as the dose of a drug divided by the area-under-the-concentration-time curve (AUC), ie. CL = Dose / AUC. For extravascu-lar models the fraction of dose absorbed cannot be estimated, therefore "clear-ance" for these models is actually Cl/F where F is the fraction of the drug dose which is absorbed.
Measured: Final (Day 14)
Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID)
Tipranavir (TPV) pharmacokinetics
Measured: Final (Day 13 for QD, Day 14 for BID)
Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID
TPV pharmacokinetics
Measured: Final (Day 13 for QD, Day 14 for BID)
Trough Concentration (Cmin) of Tipranavir
TPV pharmacokinetics
Measured: Final (Day 13 for QD, Day 14 for BID)
Maximum Concentration (Cmax) of Tipranavir
TPV pharmacokinetics
Measured: Final (Day 13 for QD, Day 14 for BID)
Volume of Distribution (V/F) of Tipranavir
Tipranavir pharmacokinetics
Measured: Final (Day 14)
Terminal Half-Life (t1/2) of Tipranavir
Tipranavir pharmacokinetics
Measured: Final (Day 14)
Time to Cmax (Tmax) of Tipranavir
Tipranavir pharmacokinetics
Measured: Final (Day 14)
AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID
Ritonavir pharmacokinetics
Measured: Final (Day 13 for QD, Day 14 for BID)
Cp 24 h of Ritonavir for QD and CP 12 h of Ritonavir for BID
Ritonavir pharmacokinetics
Measured: Final (Day 13 for QD, Day 14 for BID)
Apparent Oral Clearance I(Cl/F) of Ritonavir
Ritonavir pharmacokinetics
Measured: Final (Day 13 for QD, Day 14 for BID)
Volume of Distribution (V/F) of Ritonavir
Ritonavir pharmacokinetics
Measured: Final (Day 14)
Terminal Half-Life (t1/2) of Ritonavir
Ritonavir pharmacokinetics
Measured: Final (Day 14)
Tmax of Ritonavir
Ritonavir pharmacokinetics
Measured: Final (Day 14)
Cmax of Ritonavir
Ritonavir pharmacokinetics
Measured: Visits baseline, 5, 7, 9 and 13 or 14
Clinical Abnormal Findings in Laboratory and Physical Examination
Measured: Screening through the end of the study (14 days)

Timeline

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

Oct 2007May 2008

First posted18 Sep 2007 (estimated)
Study startOct 2007
Primary completionMay 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.
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 2
Primary purpose: Treatment
Intervention model: Parallel groups
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00530920
Sponsor's protocol ID: 1182.107
Status last verified: May 2014
First submitted: 17 Sep 2007
Last updated: 6 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

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

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Open Label, Clinical Trial to Evaluate Three Doses of Tipranavir Boosted With Ritonavir (500 mg/200 mg qd, 250 mg/100 mg Bid and 500 mg/100 mg Bid) by Assessing the Steady-state Pharmacokinetics and Short-term Efficacy and Safety in HIV-1 Positive Treatment naïve Patients
ClinicalTrials.gov ID: NCT00530920
Acronym / sponsor ID: 1182.107
Conditions: HIV Infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: May 2008 (actual)
First posted: 18 Sep 2007 (estimated)
Results: Posted 8 Jul 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 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation.
HIV-1 infected men and non-pregnant women who are treatment naïve, with positive serology (EIA) confirmed by Western blot.
Age > 18 and < 65 years.
CD4 > 200 cells/mm3
Viral load (HIV-1 mRNA viral load) > 5,000 copies/mL.

Key exclusion criteria (17 listed)

Female patients of reproductive potential who:
Suspected or documented seroconversion within last 6 months
Participation in another trial with an investigational medicine within 2 months prior to Day 0 of this study.
Use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month prior to Day 0 and for the duration of the study.
Use of hormone replacement therapy within 1 month prior to Day 0 and anytime during the study.

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	–
ritonavir	Drug	–

Primary outcome

Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))
Time frame: Baseline (Day 0) to Final (Day 14)

16 secondary outcomes

Apparent Oral Clearance I(Cl/F) of Tipranavir
Time frame: Final (Day 14)
Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID)
Time frame: Final (Day 13 for QD, Day 14 for BID)
Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID
Time frame: Final (Day 13 for QD, Day 14 for BID)
Trough Concentration (Cmin) of Tipranavir
Time frame: Final (Day 13 for QD, Day 14 for BID)
Maximum Concentration (Cmax) of Tipranavir
Time frame: Final (Day 13 for QD, Day 14 for BID)
Volume of Distribution (V/F) of Tipranavir
Time frame: Final (Day 14)
Terminal Half-Life (t1/2) of Tipranavir
Time frame: Final (Day 14)
Time to Cmax (Tmax) of Tipranavir
Time frame: Final (Day 14)
AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID
Time frame: Final (Day 13 for QD, Day 14 for BID)
Cp 24 h of Ritonavir for QD and CP 12 h of Ritonavir for BID
Time frame: Final (Day 13 for QD, Day 14 for BID)
Apparent Oral Clearance I(Cl/F) of Ritonavir
Time frame: Final (Day 13 for QD, Day 14 for BID)
Volume of Distribution (V/F) of Ritonavir
Time frame: Final (Day 14)
Terminal Half-Life (t1/2) of Ritonavir
Time frame: Final (Day 14)
Tmax of Ritonavir
Time frame: Final (Day 14)
Cmax of Ritonavir
Time frame: Visits baseline, 5, 7, 9 and 13 or 14
Clinical Abnormal Findings in Laboratory and Physical Examination
Time frame: Screening through the end of the study (14 days)

Results and safety

Results posted to the registry on 8 Jul 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 With Ritonavir (TPV/r) 500/200 mg Once Daily	30	30
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily	27	25
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily	28	24

Primary outcome: Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))

Time frame: Baseline (Day 0) to Final (Day 14). Median (Inter-Quartile Range). Unit: Log10 copies/mL

Measure	Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily n = 30	Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily n = 25	Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily n = 28
Value	-1.43 (-1.66 to -1.24)	-1.55 (-1.70 to -1.37)	-1.47 (-1.66 to -1.09)

Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily: Median Difference (Final Values): -1.43, p = 0.997, Wilcoxon (Mann-Whitney)
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily: Median Difference (Final Values): -1.55, p = 1, Wilcoxon (Mann-Whitney)
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily: Median Difference (Final Values): -1.47, p = 0.998, Wilcoxon (Mann-Whitney)

Population analysed: Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 days, from first treatment until last treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily	0 of 30 (0%)	17 of 30 (56.7%)	Not reported
Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily	0 of 25 (0%)	9 of 25 (36%)	Not reported
Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily	1 of 28 (3.6%)	15 of 28 (53.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

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

12 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tipranavir and ritonavir in people with HIV Infections, run by Boehringer Ingelheim at 12 sites in 3 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 16 inclusion and 17 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: finished, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany, Italy, Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 8 Jul 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?

Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF)) (time frame: Baseline (Day 0) to Final (Day 14)). 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 NCT00530920.

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 6 Jun 2014.