Infection, Human Immunodeficiency VirusPhase 1NCT02138084
Drug-drug Interaction (DDI) Rifabutin
A Phase 1 study testing BMS-663068, Rifabutin and Ritonavir in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United States.
Trial summary
The purpose of this study is to provide dosing recommendations for the coadministration of BMS-663068 and Rifabutin with and without Ritonavir in upcoming Phase 3 studies and for prescribing information purposes Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- BMS-663068, Rifabutin and Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2014to 24 Jul 2014
- Phase
- Phase 1
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed Written Informed Consent
- Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's Institutional Review Board (IRB) or Independent Ethics Committee (IEC) before the initiation of any protocol-required procedures
- Target Population
- a) Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory test results
- b) Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive BMI = weight (kg)/[height (m)]2
- c) Subject Reenrollment: This study permits the reenrollment of a subject that has discontinued the study as a pretreatment failure (ie, subject has not been randomized/has not been dosed). If reenrolled, the subject must be reconsented
Show all 12Show fewer
- Age and Reproductive Status
- a) Men and women, ages 18 to 50 years, inclusive
- b) Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug
- c) Women must not be breastfeeding
- d) WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of Rifabutin (13 days) plus 30 days (duration of ovulatory cycle) for a total of 43 days posttreatment completion
- e) Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of Rifabutin (13 days) plus 90 days (duration of sperm turnover) for a total of 103 days posttreatment completion
Who cannot join
- Medical History and Concurrent Diseases
- a) Any significant acute or chronic medical illness as determined by the Investigator.
- b) Current or recent (within 3 months of study drug administration) gastrointestinal disease
- c) Any major surgery within 4 weeks of study drug administration
- d) Any gastrointestinal surgery that could impact upon the absorption of study drug
- e) Intractable diarrhea (≥6 loose stools per day for at least 7 consecutive days) within 30 days prior to the first dose of study drug
Show all 18Show fewer
- f) History of acute or chronic pancreatitis
- g) History of active or latent tuberculosis or any recent exposure to someone with tuberculosis
- h) History of uveitis and/or current eye or vision problems with the exception of corrective lenses
- i) Contact lens use during study drug administration or the need for contact lenses during study drug administration
- j) Donation of blood to a blood bank or in a clinical study (except screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma donation only)
- k) Blood transfusion within 4 weeks of study drug administration.
- l) History of any hemolytic disorders, including drug-induced hemolysis.
- m) Inability to tolerate oral medication
- n) Inability to be venipunctured and/or tolerate venous access
- o) Recent (within 6 months of study drug administration) history of smoking or current smokers
- p) Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), Diagnostic Criteria for Drug and Alcohol Abuse
- q) Any other sound medical, psychiatric, and/or social reason as determined by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Interaction Study to Evaluate the Pharmacokinetic Effect of Rifabutin on BMS-626529, the Active Moiety of BMS-663068, With and Without Ritonavir in Healthy Subjects
The purpose of this study is to provide dosing recommendations for the coadministration of BMS-663068 and Rifabutin with and without Ritonavir in upcoming Phase 3 studies and for prescribing information purposes
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- BMS-663068, Rifabutin, Ritonavir
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-663068Drug
BMS-663068
RifabutinDrug
Rifabutin
RitonavirDrug
Ritonavir
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: BMS-663068 + Rifabutin | Experimental | Regimen A: BMS-663068 tablet by mouth as specified
Regimen B: BMS-663068 tablet with Rifabutin capsule by mouth as specified Receives: Drug: BMS-663068; Drug: Rifabutin |
| Cohort 2: BMS-663068 + Rifabutin + Ritonavir | Experimental | Regimen A: BMS-663068 tablet by mouth as specified
Regimen C: BMS-663068 tablet, Rifabutin capsule and Ritonavir (RTV) capsule by mouth as specified Receives: Drug: BMS-663068; Drug: Rifabutin; Drug: Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of BMS-626529
Measured: Day 2 to Day 15
Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-626529
Measured: Day 2 to Day 15
Secondary outcomes (4)
Time of maximum observed plasma concentration (Tmax) of BMS-626529
Measured: Day 2 to Day 15
Concentration at 12 hours after dosing (C12) of BMS-626529
Measured: Day 2 to Day 15
Trough observed plasma concentration (Ctrough) of BMS-626529 (predose)
Measured: Day 2 to Day 15
Safety and tolerability include incidence of adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, deaths, marked laboratory abnormalities, and abnormalities in vital signs, physical examination, and 12-lead electrocardiograms (ECGs)
Measured: Up to Day 30 after discontinuation of dose (approximately 45 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study start14 May 2014
- Primary completion24 Jul 2014
- Study completion24 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138084
- Sponsor's protocol ID
- 206282
- Other IDs
- AI438-041
- Status last verified
- Sep 2017
- First submitted
- 13 May 2014
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Interaction Study to Evaluate the Pharmacokinetic Effect of Rifabutin on BMS-626529, the Active Moiety of BMS-663068, With and Without Ritonavir in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02138084
- Acronym / sponsor ID
- 206282
- Conditions
- Infection, Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 14 May 2014 (actual)
- Primary completion
- 24 Jul 2014 (actual)
- Study completion
- 24 Jul 2014 (actual)
- First posted
- 14 May 2014 (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.
The purpose of this study is to provide dosing recommendations for the coadministration of BMS-663068 and Rifabutin with and without Ritonavir in upcoming Phase 3 studies and for prescribing information purposes
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: BMS-663068 + Rifabutin | Experimental | Drug: BMS-663068, Drug: RifabutinRegimen A: BMS-663068 tablet by mouth as specified Regimen B: BMS-663068 tablet with Rifabutin capsule by mouth as specified |
| Cohort 2: BMS-663068 + Rifabutin + Ritonavir | Experimental | Drug: BMS-663068, Drug: Rifabutin, Drug: RitonavirRegimen A: BMS-663068 tablet by mouth as specified Regimen C: BMS-663068 tablet, Rifabutin capsule and Ritonavir (RTV) capsule by mouth as specified |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Signed Written Informed Consent
- Target Population
- Age and Reproductive Status
Key exclusion criteria (18 listed)
- Medical History and Concurrent Diseases
- a) Any significant acute or chronic medical illness as determined by the Investigator.
- b) Current or recent (within 3 months of study drug administration) gastrointestinal disease
- c) Any major surgery within 4 weeks of study drug administration
- d) Any gastrointestinal surgery that could impact upon the absorption of study drug
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 |
|---|---|---|
| BMS-663068BMS-663068 | Drug | Cohort 1: BMS-663068 + Rifabutin, Cohort 2: BMS-663068 + Rifabutin + Ritonavir |
| RifabutinRifabutin | Drug | Cohort 1: BMS-663068 + Rifabutin, Cohort 2: BMS-663068 + Rifabutin + Ritonavir |
| RitonavirRitonavir | Drug | Cohort 2: BMS-663068 + Rifabutin + Ritonavir |
Primary outcome
Maximum observed plasma concentration (Cmax) of BMS-626529
Time frame: Day 2 to Day 15
Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-626529
Time frame: Day 2 to Day 15
4 secondary outcomes
Time of maximum observed plasma concentration (Tmax) of BMS-626529
Time frame: Day 2 to Day 15
Concentration at 12 hours after dosing (C12) of BMS-626529
Time frame: Day 2 to Day 15
Trough observed plasma concentration (Ctrough) of BMS-626529 (predose)
Time frame: Day 2 to Day 15
Safety and tolerability include incidence of adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, deaths, marked laboratory abnormalities, and abnormalities in vital signs, physical examination, and 12-lead electrocardiograms (ECGs)
Time frame: Up to Day 30 after discontinuation of dose (approximately 45 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
Related trials for Infection, Human Immunodeficiency Virus
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)
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
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.
GSK Clinical Trials study director
ViiV Healthcare
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 BMS-663068, Rifabutin and Ritonavir in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare 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 12 inclusion and 18 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 25 Sep 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum observed plasma concentration (Cmax) of BMS-626529 (time frame: Day 2 to Day 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2017.