Infection, Human Immunodeficiency Virus IPhase 1NCT01597648

A Study to Evaluate the Bioequivalence of a Combined Formulated Tablet Compared With Maraviroc and Combivir™

A Phase 1 study testing Maraviroc, Combivir and GSK2838510 in people with Infection, Human Immunodeficiency Virus I, run by GlaxoSmithKline.

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: Infection, Human Immunodeficiency Virus I
What is being tested?: Maraviroc, Combivir and GSK2838510
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: No sites listed yet
Study dates: Nov 2011to Jan 2012
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female subjects 18 to 55 years of age (inclusive); healthy as determined by a responsible physician, based on a medical evaluation, including medical history, vital sign measurements, physical examination, clinical laboratory tests, and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator and the Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
A female subject is eligible to participate if she is of: Non childbearing potential, defined as premenopausal females with a documented tubal ligation or hysterectomy; or postmenopausal, defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle stimulating hormone [FSH] greater than 40 MlU/mL and estradiol less than 40 pg/mL (less than 146.8 pmol/L) is confirmatory). Childbearing potential and is abstinent (abstinence from penile-vaginal intercourse must be consistent with the preferred and usual lifestyle of the subject) or agrees to use 1 of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 30 days after the study.
The subject has alanine aminotransferase, alkaline phosphatase, and bilirubin less than and equal to 1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is less than 35%).
Subject has a QTcB <450 msec.
The subject has a body mass index (BMI) between 18.5 and 31.0 kg/m2 (inclusive) and a total body weight greater than and equal to 45 kg for females and ≥50 kg for males.
The subject provides written informed consent.
The subject is a current nonsmoker greater than 3 months.

Who cannot join

The subject has a positive prestudy drug/alcohol screen. At minimum, the drug screen will include alcohol, cotinine, amphetamines, barbiturates, cocaine, opiates, cannabinoids, and benzodiazepines.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
The subject has a history of sensitivity to any of the study drugs, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates the subject's participation.
The subject is unable to refrain from the use of prescription or nonprescription drugs, including vitamins and herbal and dietary supplements (including St. John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study drug, unless in the opinion of the investigator and Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
The subject has a history of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 14 drinks/week for men or greater than 7 drinks/week for women.
The subject has consumed red wine, Seville oranges, grapefruit, or grapefruit juice within 7 days prior of the first dose of study drug.

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The female subject is pregnant as determined by positive serum or urine human chorionic gonadotrophin (hCG) test at screening or before dosing.
The female subject is lactating.
The subject is unwilling or unable to follow the procedures outlined in the protocol.
The subject has a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic, and/or renal function that could interfere with the absorption, metabolism, and/or excretion of the study drugs. A subject with a history of cholecystectomy, peptic ulceration, inflammatory bowel disease, or pancreatitis should be excluded.
The subject has a positive prestudy hepatitis B surface antigen, hepatitis C antibody, or HIV antibody result.
The subject has a history of Gilbert's disease.
The subject's participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56-day period.
The subject has systolic blood pressure outside the range of 90-140 mmHg, diastolic blood pressure outside the range of 45-90 mmHg, or heart rate outside the range of 50-100 bpm for female subjects or 45-100 bpm for male subjects. A single repeat measurement is allowed for eligibility determination.
The subject meets any of the following exclusion criteria for the screening ECG (a single repeat ECG is allowed for eligibility determination): Males heart rate: less than 45 or greater than 100 bpm; females heart rate: less than 50 or greater than 100 bpm; Males and females PR interval: less than 120 or greater than 220 msec; Males and females QRS duration: less than 70 or greater than 120 msec; Males and females QTcB: greater than 450 msec. Evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization). Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular block [2nd degree or higher], and Wolf Parkinson White syndrome). Sinus pauses greater than 3 seconds. Any significant arrhythmia which, in the opinion of the principal investigator and Medical Monitor, will interfere with the safety for the individual subject. Nonsustained or sustained ventricular tachycardia (greater than and equal to 3 consecutive ventricular ectopic beats).
The subject is unwilling or unable to follow the procedures outlined in the protocol.

About this study

Official title: A Randomized, Open-Label, Crossover Study to Evaluate the Bioequivalence of a Combined Formulated Tablet Compared With Maraviroc and Combivir™ Administered Concurrently in Healthy Adult Subjects

This is a study in healthy adult subjects to evaluate the bioequivalence of a Combined Formulated Tablet compared with maraviroc and Combivir administered concurrently versus maraviroc + Combivir. 42 subjects will be enrolled in the study such that 40 subjects complete dosing and critical assessments. The total duration of a subject's participation will be approximately 33 to 35 days, including a screening period (Day -21 to Day -1), 2 treatment periods (Days 1-3), at least a 7-day washout between Period 1 and Period 2, and a follow-up visit 7 to 14 days after the last dose of study drug in Period 2. Each dosing period will begin the evening prior to dosing and extend until 48 hours (Day 3) after dosing. Subjects will be randomly assigned to receive 1 of the following 2 treatments in Period 1 then crossover to receive the alternate treatment in Period 2:

In Sequence 1 (N=21) subjects will receive Treatment A followed by a 7 day washout and Treatment B. In Sequence 2 (N=21) subjects will receive Treatment B followed by a 7 day washout and Treatment A. Treatment A consists of 1 tablet of maraviroc 300 mg, lamivudine 150 mg, and zidovudine 300 mg as a combined formulation after an overnight fast. Treatment B consists of 1 tablet of maraviroc 300 mg + 1 tablet of Combivir taken concurrently after an overnight fast. On Day 1 of each treatment period, subjects will receive study drug in the morning after an overnight fast of at least 8 hours. Study drug will be administered with 240 mL of water. Dosing in each treatment period will be separated by a minimum washout period of at least 7 days between doses. All subjects will undergo safety and other assessments. Subjects may be discharged after all study procedures are completed on the morning of Day 3, with instructions to return for the next study period or the follow-up visit, as appropriate. The follow-up visit will occur 7 to 14 days after the last dose of study drug in Period 2. Pharmacokinetic blood samples will be collected during each treatment period for evaluation of maraviroc, lamivudine, and zidovudine before dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours after dosing (total of 16 PK time points per treatment period). Protocol waivers or exemptions are not allowed, with the exception of immediate safety concerns. Therefore, adherence to the study protocol requirements, including those specified in the Time and Events Table, are essential and required for study conduct.

Conditions: Infection, Human Immunodeficiency Virus I
Being tested: Maraviroc, Combivir, GSK2838510
Keywords: Combivir™, HIV, bioequivalence, Combined Formulated Tablet, Combined Formulated Tablet, HIV, bioequivalence, Combivir, Selzentry™, Celsentri™, lamivudine, zidov
Medical subject headings: Infections

What participants receive

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

MaravirocDrug
300 mg
CombivirDrug
1 tablet: lamivudine 150mg, zidovudine 300mg
GSK2838510Drug
Maraviroc 300mg, lamivudine 150mg, zidovudine 300mg

Study groups in NCT01597648
Study group	Role	What they receive
Sequence 1	Experimental	Treatment A: 1 tablet of GSK2838510 (maraviroc 300 mg, lamivudine 150 mg, and zidovudine 300 mg as a combined formulation) after an overnight fast Washout Treatment B: 1 tablet of maraviroc 300 mg + 1 tablet of Combivir taken concurrently after an overnight fast. Receives: Drug: Maraviroc; Drug: Combivir; Drug: GSK2838510
Sequence 2	Experimental	Treatment B: 1 tablet of maraviroc 300 mg + 1 tablet of Combivir taken concurrently after an overnight fast. Washout Treatment A: 1 tablet of GSK2838510 (maraviroc 300 mg, lamivudine 150 mg, and zidovudine 300 mg as a combined formulation) after an overnight fast Receives: Drug: Combivir

What is being measured

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

Safety parameters: AEs, vital signs, ECG, body temperature and laboratory assessments, including haematology, clinical biochemistry and cardiac troponin
To assess the safety and tolerability of single and repeat inhaled doses of GSK2339345 administered by an aqueous droplet inhaler
Measured: Approximately 5 weeks from first dose to the follow-up visit
Assessment of oropharyngeal sensation perturbation via a 4 point scale
To assess the changes in oropharyngeal sensation caused by single and repeat inhaled doses of GSK2339345 administered by an aqueous droplet inhaler
Measured: Approximately 5 weeks from first dose to the follow-up visit

Secondary outcomes (2)

Plasma concentrations of GSK2339345 and single and repeat dose derived pharmacokinetic parameters including Cmax, tmax, AUC(0-t), AUC(0-inf), and AUC(0- τ), as appropriate where data allow
To evaluate the systemic pharmacokinetics of single and repeat doses of inhaled GSK2339345 in healthy volunteers administered by an aqueous droplet inhaler
Measured: Approximately 5 weeks from first dose to the follow-up visit
Identification of taste of the solution and rating on 11 point scale to rate pleasantness or unpleasantness
To assess the palatability of GSK2339345 administered by an aqueous droplet inhaler
Measured: Approximately 5 weeks from first dose to the follow-up visit

Timeline

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

Nov 2011Jan 2012

First posted14 May 2012 (estimated)
Study startNov 2011
Primary completionJan 2012
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Infection, Human Immunodeficiency Virus IStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01597648
Sponsor's protocol ID: 115325
Status last verified: May 2012
First submitted: 3 May 2012
Last updated: 21 May 2012
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?

Official record

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All Infection, Human Immunodeficiency Virus I trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Crossover Study to Evaluate the Bioequivalence of a Combined Formulated Tablet Compared With Maraviroc and Combivir™ Administered Concurrently in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT01597648
Acronym / sponsor ID: 115325
Conditions: Infection, Human Immunodeficiency Virus I
Keywords: Combivir™, HIV, bioequivalence, Combined Formulated Tablet, Combined Formulated Tablet, HIV, bioequivalence, Combivir, Selzentry™, Celsentri™, lamivudine, zidov
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 14 May 2012 (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.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequence 1	Experimental	Drug: Maraviroc, Drug: Combivir, Drug: GSK2838510Treatment A: 1 tablet of GSK2838510 (maraviroc 300 mg, lamivudine 150 mg, and zidovudine 300 mg as a combined formulation) after an overnight fast Washout Treatment B: 1 tablet of maraviroc 300 mg + 1 tablet of Combivir taken concurrently after an overnight fast.
Sequence 2	Experimental	Drug: CombivirTreatment B: 1 tablet of maraviroc 300 mg + 1 tablet of Combivir taken concurrently after an overnight fast. Washout Treatment A: 1 tablet of GSK2838510 (maraviroc 300 mg, lamivudine 150 mg, and zidovudine 300 mg as a combined formulation) after an overnight fast

Who may qualify

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

Key inclusion criteria (7 listed)

Healthy male and female subjects 18 to 55 years of age (inclusive); healthy as determined by a responsible physician, based on a medical evaluation, including medical history, vital sign measurements, physical examination, clinical laboratory tests, and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator and the Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
A female subject is eligible to participate if she is of: Non childbearing potential, defined as premenopausal females with a documented tubal ligation or hysterectomy; or postmenopausal, defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle stimulating hormone [FSH] greater than 40 MlU/mL and estradiol less than 40 pg/mL (less than 146.8 pmol/L) is confirmatory). Childbearing potential and is abstinent (abstinence from penile-vaginal intercourse must be consistent with the preferred and usual lifestyle of the subject) or agrees to use 1 of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 30 days after the study.
The subject has alanine aminotransferase, alkaline phosphatase, and bilirubin less than and equal to 1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is less than 35%).
Subject has a QTcB <450 msec.
The subject has a body mass index (BMI) between 18.5 and 31.0 kg/m2 (inclusive) and a total body weight greater than and equal to 45 kg for females and ≥50 kg for males.

Key exclusion criteria (16 listed)

The subject has a positive prestudy drug/alcohol screen. At minimum, the drug screen will include alcohol, cotinine, amphetamines, barbiturates, cocaine, opiates, cannabinoids, and benzodiazepines.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
The subject has a history of sensitivity to any of the study drugs, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates the subject's participation.
The subject is unable to refrain from the use of prescription or nonprescription drugs, including vitamins and herbal and dietary supplements (including St. John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study drug, unless in the opinion of the investigator and Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
The subject has a history of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 14 drinks/week for men or greater than 7 drinks/week for women.

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
Maraviroc300 mg	Drug	Sequence 1
Combivir1 tablet: lamivudine 150mg, zidovudine 300mg	Drug	Sequence 1, Sequence 2
GSK2838510Maraviroc 300mg, lamivudine 150mg, zidovudine 300mg	Drug	Sequence 1

Primary outcome

Safety parameters: AEs, vital signs, ECG, body temperature and laboratory assessments, including haematology, clinical biochemistry and cardiac troponin
Time frame: Approximately 5 weeks from first dose to the follow-up visit
To assess the safety and tolerability of single and repeat inhaled doses of GSK2339345 administered by an aqueous droplet inhaler
Assessment of oropharyngeal sensation perturbation via a 4 point scale
Time frame: Approximately 5 weeks from first dose to the follow-up visit
To assess the changes in oropharyngeal sensation caused by single and repeat inhaled doses of GSK2339345 administered by an aqueous droplet inhaler

2 secondary outcomes

Plasma concentrations of GSK2339345 and single and repeat dose derived pharmacokinetic parameters including Cmax, tmax, AUC(0-t), AUC(0-inf), and AUC(0- τ), as appropriate where data allow
Time frame: Approximately 5 weeks from first dose to the follow-up visit
Identification of taste of the solution and rating on 11 point scale to rate pleasantness or unpleasantness
Time frame: Approximately 5 weeks from first dose to the follow-up visit

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 21 May 2012.

Related trials for Infection, Human Immunodeficiency Virus I

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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.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Maraviroc, Combivir and GSK2838510 in people with Infection, Human Immunodeficiency Virus I, run by GlaxoSmithKline.

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 7 inclusion and 16 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 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.

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?

Safety parameters: AEs, vital signs, ECG, body temperature and laboratory assessments, including haematology, clinical biochemistry and cardiac troponin (time frame: Approximately 5 weeks from first dose to the follow-up visit). 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?

On the ClinicalTrials.gov record for NCT01597648.

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 21 May 2012.