HIV InfectionsPhase 1NCT01340196

Drug Drug Interaction of BI 201335 and Tenofovir

A Phase 1 study testing tenofovir/BI 201335 in people with HIV Infections, run by Boehringer Ingelheim at 1 site in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: tenofovir/BI 201335
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Apr 2011to Jun 2011
Phase: Phase 1
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males and female subjects and according to medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram and clinical laboratory tests; all with acceptable findings.
Age =18 to =55 years
Weighing at least 50 kg, and body mass index >=18.5 and BMI <=29.9 kg/m2 (Body Mass Index).
Volunteers must not leave the research unit, during the entire length of the study and must be willing to comply with the protocol and complete all study-related activities.

Who cannot join

Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance, as assessed by the investigator.
Active diseases of the gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, musculoskeletal, immunologic, rheumatologic, hormonal, neurological system, clinically relevant electrolyte disorders or bleeding disorders that require current medical treatment.
Diseases of the central nervous system or psychiatric disorders.
History of photosensitivity or recurrent rash.
History of orthostatic hypotension, fainting spells or blackouts.
Chronic or clinically relevant acute infections.

Show all 29Show fewer

History of allergy/hypersensitivity (including drug allergy) which is deemed relevant.
Intake of drugs with a long half-life >24:00 hours within at least one month or less than ten half lives of the respective drug before enrollment in the study (with the exception of hormonal contraceptives).
Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment as nutraceuticals and herbal remedies that would interfere with either the absorption, distribution or metabolism of BI 201335 NA, or that prolong the QT/QTc interval.
Use of any investigational drug within 30 days prior to enrollment; or the planned use of any investigational drug during the course of the current study.
Smoking (>10 cigarettes or >3 cigars or >3 pipes/day)
Inability to abstain from smoking more than 3 cigarettes/day during the period of dosing with study medication.
Drug and alcohol abuse (>60g/day).
Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
Excessive physical activities within one week prior to administration or during the trial.
Any laboratory value outside the reference range that is of clinical relevance at screening, according to the judgment of the investigator, and in consultation with the clinical monitor.
Known elevated liver enzymes in past with any compound (experimental or marketed).
Concomitant administration of any food product known to alter P450 enzyme activity such as grapefruit juice, Seville oranges, St. John's Wort.
Concomitant administration of oral contraceptives (subjects who stopped oral contraceptives at least 7 days prior to Day 1 may be included.
Inadequate venous access.
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF, or QTcB interval >450 ms).
Infection with hepatitis B (HBV), or hepatitis C virus (HCV),
Positive test for HIV-1 or HIV-2. For women of child bearing potential (WOCBP)
Pregnancy or planning to become pregnant within 2 months of study completion
Positive pregnancy test at screening visit
No proof of sterilization, or not willing or unable to consistently use an acceptable method of double barrier contraception including IUD, or diaphragm with spermicidal cream/jelly and condoms for male partner, during and up to 3 months after completion/termination of the trial.
Lactation period with active breastfeeding from time of screening to 30 days after end of trial visit.
For male subjects
No proof of sterilization, or not willing or unable to consistently use an acceptable method of double barrier contraception including a condom each time and female partner of child bearing potential consistently uses oral birth control pills, or an IUD, or a diaphragm with spermicidal cream/jelly). Male subjects must not father a child from administration of the first dose and up to 3 months after the last dose of study medication.

Trial locations and contacts

1 site in 1 country.

United States1 site

1220.50.0001 Boehringer Ingelheim Investigational Site
Buffalo, New York

Other trials in United States

About this study

Official title: Effect of Multiple Dosing With 240 mg BID BI 201335 on the Steady State Pharmacokinetics of 300mg QD Tenofovir and Effect of Multiple Dosing With 300mg QD Tenofovir on Steady State BI 201335 Pharmacokinetics in Healthy Male and Female Volunteers

The objective of this study is to evaluate the drug-drug interaction potential between BI 201335 and concomitantly administered tenofovir which is used in treatment regimens for HIV infection and/or Hepatitis B infection. Results of this study will serve as a basis for guidance of dose adjustments or other precautionary measures when BI201335 and tenofovir are coadministered.

Conditions: HIV Infections
Being tested: tenofovir/BI 201335
Medical subject headings: HIV Infections

What participants receive

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

tenofovir/BI 201335Drug
tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through 22 with last dose on morning of day 22

Study groups in NCT01340196
Study group	Role	What they receive
sequence 1	Experimental	tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through day 22 (morning dose on day 22 only) Receives: Drug: tenofovir/BI 201335

What is being measured

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

Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15
Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-24 hours, at steady state.
Measured: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15
Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15
Maximum measured concentration of analyte in plasma (Cmax), at steady state.
Measured: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00. 192:00 hours on day 15
Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15
Measured concentration of the analyte in plasma at 24 h (C24hr) after dosing, at steady state.
Measured: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15
Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22
Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-12 hours, at steady state.
Measured: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22
Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22
Maximum measured concentration of analyte in plasma (Cmax), at steady state.
Measured: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22
Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22
Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state.
Measured: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22

Secondary outcomes (2)

Number of Patients With Drug Related Adverse Events During the Trial
Outcome data are the numbers of subjects with investigator defined drug-related AEs
Measured: From drug administration up to 32 days.
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG
Clinical relevant abnormalities for physical examination, vital signs, safety laboratory tests and 12-lead ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Preferred term of relevant AE: Presyncope
Measured: From drug administration up to 32 days.

Timeline

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

Apr 2011Jun 2011

First posted22 Apr 2011 (estimated)
Study startApr 2011
Primary completionJun 2011

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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01340196
Sponsor's protocol ID: 1220.50
Status last verified: Jul 2015
First submitted: 20 Apr 2011
Last updated: 31 Jul 2015
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

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Multiple Dosing With 240 mg BID BI 201335 on the Steady State Pharmacokinetics of 300mg QD Tenofovir and Effect of Multiple Dosing With 300mg QD Tenofovir on Steady State BI 201335 Pharmacokinetics in Healthy Male and Female Volunteers
ClinicalTrials.gov ID: NCT01340196
Acronym / sponsor ID: 1220.50
Conditions: HIV Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Jun 2011 (actual)
First posted: 22 Apr 2011 (estimated)
Results: Posted 31 Jul 2015

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
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
sequence 1	Experimental	Drug: tenofovir/BI 201335tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through day 22 (morning dose on day 22 only)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy males and female subjects and according to medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram and clinical laboratory tests; all with acceptable findings.
Age =18 to =55 years
Weighing at least 50 kg, and body mass index >=18.5 and BMI <=29.9 kg/m2 (Body Mass Index).
Volunteers must not leave the research unit, during the entire length of the study and must be willing to comply with the protocol and complete all study-related activities.

Key exclusion criteria (29 listed)

Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance, as assessed by the investigator.
Active diseases of the gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, musculoskeletal, immunologic, rheumatologic, hormonal, neurological system, clinically relevant electrolyte disorders or bleeding disorders that require current medical treatment.
Diseases of the central nervous system or psychiatric disorders.
History of photosensitivity or recurrent rash.
History of orthostatic hypotension, fainting spells or blackouts.

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
tenofovir/BI 201335tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through 22 with last dose on morning of day 22	Drug	sequence 1

Primary outcome

Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15
Time frame: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15
Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-24 hours, at steady state.
Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15
Time frame: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00. 192:00 hours on day 15
Maximum measured concentration of analyte in plasma (Cmax), at steady state.
Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15
Time frame: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15
Measured concentration of the analyte in plasma at 24 h (C24hr) after dosing, at steady state.
Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22
Time frame: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22
Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-12 hours, at steady state.
Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22
Time frame: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22
Maximum measured concentration of analyte in plasma (Cmax), at steady state.
Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22
Time frame: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22
Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state.

2 secondary outcomes

Number of Patients With Drug Related Adverse Events During the Trial
Time frame: From drug administration up to 32 days.
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG
Time frame: From drug administration up to 32 days.

Results and safety

Results posted to the registry on 31 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	16	16

Primary outcome: Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15

Time frame: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Tenofovir n = 16	Tenofovir/Faldaprevir n = 16	Faldaprevir n = 0
Value	2700 (26.5)	3290 (19.6)	–

Tenofovir vs Tenofovir/Faldaprevir: Geometric mean ratio: 121.89 (90% CI 111.714 to 132.999), ANOVA

Population analysed: All participants from the pharmacokinetic analysis set (PK set), including all subjects who were documented to have taken at least one dose of trial medication (treated set) who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.

Primary outcome: Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15

Time frame: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00. 192:00 hours on day 15. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Tenofovir n = 16	Tenofovir/Faldaprevir n = 16	Faldaprevir n = 0
Value	300 (27.3)	284 (16.6)	–

Tenofovir vs Tenofovir/Faldaprevir: Geometric mean ratio: 94.72 (90% CI 85.215 to 105.290), ANOVA

Population analysed: All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.

Primary outcome: Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15

Measure	Tenofovir n = 16	Tenofovir/Faldaprevir n = 16	Faldaprevir n = 0
Value	54.0 (26.7)	79.4 (21.5)	–

Tenofovir vs Tenofovir/Faldaprevir: Geometric mean ratio: 147.12 (90% CI 134.482 to 160.943), ANOVA

Primary outcome: Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22

Time frame: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Tenofovir n = 0	Tenofovir/Faldaprevir n = 16	Faldaprevir n = 14
Value	–	418000 (69.3)	523000 (101)

Tenofovir/Faldaprevir vs Faldaprevir: Geometric mean ratio: 77.88 (90% CI 71.24 to 85.15), ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration up to 32 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tenofovir	0 of 16 (0%)	1 of 16 (6.3%)	Not reported
Tenofovir/Faldaprevir	0 of 16 (0%)	16 of 16 (100%)	Not reported
Faldaprevir	0 of 16 (0%)	10 of 16 (62.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tenofovir/BI 201335 in people with HIV Infections, run by Boehringer Ingelheim at 1 site in United States.

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 4 inclusion and 29 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 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 31 Jul 2015). 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?

Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15 (time frame: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15). The study lists 6 primary outcomes in all. 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 NCT01340196.

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 31 Jul 2015.