Human Immunodeficiency Virus Type 1 (HIV-1)Phase 1AtazanavirNCT01837719

Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat

A Phase 1 study testing Atazanavir, Cobicistat and Atazanavir/Cobicistat FDC in people with Human Immunodeficiency Virus Type 1 (HIV-1), run by Bristol-Myers Squibb 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

The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents. Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Human Immunodeficiency Virus Type 1 (HIV-1)
What is being tested?: Atazanavir, Cobicistat and Atazanavir/Cobicistat FDC
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: Apr 2013to Jun 2013
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 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy men and women, ages 18 to 49 years
Body mass index 18 to 32 kg/m^2, inclusive
Women of childbearing potential (WOCBP) who were not pregnant or breastfeeding
WOCBP and men who are sexually active with WOCBP must use acceptable contraceptive methods

Who cannot join

Any significant acute or chronic medical illness
Current or recent (within 3 months of study drug administration) gastrointestinal tract disease
Any major surgery within 4 weeks of study drug administration
Any gastrointestinal tract surgery (including cholecystectomy) that could have an impact on the absorption of study drug
Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
Blood transfusion within 4 weeks of study drug administration

Show all 21Show fewer

Inability to tolerate oral medication, to be venipunctured, or to tolerate venous access
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination or electrocardiogram (ECG) findings, vital sign measurements, or results of clinical laboratory tests, beyond what is consistent with the target population
Any of the following 12-lead ECG findings prior to study drug administration, confirmed by repeat testing
PR ≥210 msec
QRS ≥120 msec
QT ≥500 msec
QTcF ≥450 msec
2nd- or 3rd-degree A-V block or clinically relevant abnormalities in ECG findings
Positive result on urine screening for drugs of abuse
Positive result on blood screening for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 or -2 antibody
Laboratory test results indicating levels outside of the ranges specified below:
Alanine aminotransferase >upper limit of normal (ULN)
Aspartate aminotransferase >ULN
Total bilirubin >ULN
Serum creatinine >ULN

Trial locations and contacts

1 site in 1 country.

United States1 site

Ppd Development, Inc.
Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Randomized, 5-Period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of Atazanavir When Co-Administered With Cobicistat as a Fixed Dose Combination Relative to the Single Agents Following a Light Meal, the Relative Bioavailability of Atazanavir When Co-Administered With Cobicistat as a Fixed Dose Combination Relative to the Single Agents Under Fasted Conditions, and the Effect of Food on the Bioavailability of Atazanavir in the Fixed Dose Combination

Conditions: Human Immunodeficiency Virus Type 1 (HIV-1)
Being tested: Atazanavir, Cobicistat, Atazanavir/Cobicistat FDC
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

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

AtazanavirDrug
Also called BMS-232632
300-mg capsule
CobicistatDrug
150-mg tablet
Atazanavir/Cobicistat FDCDrug
Atazanavir 300-mg/cobicistat 150-mg FDC tablet

Study groups in NCT01837719
Study group	Role	What they receive
Treatment A: Atazanavir + Cobicistat coadministered	Experimental	Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8 Receives: Drug: Atazanavir; Drug: Cobicistat
Treatment B: Atazanavir/Cobicistat FDC	Experimental	Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8 Receives: Drug: Atazanavir/Cobicistat FDC
Treatment C: Atazanavir + Cobicistat coadministered	Experimental	Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22 Receives: Drug: Atazanavir; Drug: Cobicistat
Treatment D: Atazanavir/Cobicistat FDC	Experimental	Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22 Receives: Drug: Atazanavir/Cobicistat FDC
Treatment E: Atazanavir/Cobicistat FDC	Experimental	Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29 Receives: Drug: Atazanavir/Cobicistat FDC

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) of Atazanavir
Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Cmax was derived from plasma concentration versus time data.
Measured: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and From Time 0 to Infinity (AUC[INF]) for Atazanavir
Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. AUC(0-T) and AUC(INF) were derived from plasma concentration versus time data.
Measured: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)

Secondary outcomes (10)

Number of Participants Who Died and With Serious Adverse Events (SAEs)
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant who receives an investigational product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE is any untoward medical occurrence that at any dose results in death; is life-threatening; or requires or prolongs inpatient hospitalization.
Measured: On Day 24 or 31
Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests
LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment; h=high; hpf=high power field. Abnormal criteria: Leukocytes, low (*10^3 c/uL): <0.85*preRx if preRx<LLN; <0.9*LLN if LLN≤preRx≤ULN;< 0.9*LLN if preRx=missing;<LLN if preRX>ULN. Neutrophils, low (*10^3 c/uL): <0.85*preRx if preRx<1.5; <1.5 if preRx=missing; <1.5 if preRx ≥1.5. Bilirubin, h (mg/dL): >1.1* ULN if preRx≤ULN; >1.1*ULN if preRx=missing; >1.25*preRx if preRx>ULN. Bilirubin, h (mg/dL): >1.1* ULN if preRx≤ULN; >1.1*ULN if preRx=missing; >1.25*preRx if preRx>ULN. Blood, urine, h: ≥2*preRx if preRx≥1; ≥2 if preRx <1; ≥2 if preRx=missing. RBCs/WBCs, h (hpf): ≥2 if preRx=missing ≥2 if preRx<2 ≥4 if preRx ≥2. Creatine kinase, h (U/L): >1.5*preRx if preRx>ULN; >1.5*ULN if preRx≤ULN; >1.5*ULN if preRx=missing; AST, h (U/L): >1.25* preRx if preRx>ULN; >1.25*ULN if preRx≤ULN; >1.25*ULN if preRx=missing. Lactate dehydrogenase, h (U/L): >1.25*ULN if preRx≤ULN; >1.25*ULN if preRx=missing; >1.5*preRx if preRx>ULN.
Measured: At Screening and on Days -1,4, 11, 18, and 31 (study discharge)
Number of Participants With Out-of-range Intervals on Electrocardiogram (ECG) Findings
A 12-lead ECG was recorded at predose and 4 hours post dose at screening, Days -1, 1, 8 15, 22, 29 and study discharge. ECGs were recorded after the patient had been supine for at least 5 minutes. All ECG readings post dosing (including unscheduled) were included.
Measured: At screening; on Day -1; predose and 4 hours postdose on Days 1, 18, 15, 22, and 29; and at study discharge (Day 31)
Time of Maximum Observed Concentration (Tmax) of Atazanavir
Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Tmax was derived from plasma concentration versus time data.
Measured: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)
Observed Concentration at 24 Hours (C24) of Atazanavir
Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. C24 was derived from plasma concentration versus time data.
Measured: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)
Apparent Terminal Half-life (T-HALF) of Atazanavir
Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. T-HALF was derived from plasma concentration versus time data.
Measured: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)
Maximum Observed Plasma Concentration (Cmax) of Cobicistat
Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Cmax was derived from plasma concentration versus time data.
Measured: Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)
Time of Maximum Observed Concentration (Tmax) of Cobicistat
Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Tmax was derived from plasma concentration versus time data.
Measured: Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)
Area Under the Concentration Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and Area Under the Concentration Curve From Time 0 to Infinity (AUC[INF]) of Cobicistat
Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. AUC(0-T) and AUC(INF) were derived from plasma concentration versus time data.
Measured: Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)
T-HALF of Cobicistat
Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. T-HALF was derived from plasma concentration versus time data.
Measured: Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)

Timeline

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

Apr 2013Jun 2013

First posted23 Apr 2013 (estimated)
Study startApr 2013
Primary completionJun 2013
Study completionJun 2013

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 Human Immunodeficiency Virus Type 1 (HIV-1)Studies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe 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: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01837719
Sponsor's protocol ID: AI424-511
Acronym: Atazanavir
Status last verified: Aug 2014
First submitted: 18 Apr 2013
Last updated: 29 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sevinsky H, Tao X, Wang R, Ravindran P, Sims K, Xu X, Jariwala N, Bertz R. A randomized trial in healthy subjects to assess the bioequivalence of an atazanavir/cobicistat fixed-dose combination tablet versus administration as separate agents. Antivir Ther. 2015;20(5):493-500. doi: 10.3851/IMP2913. Epub 2014 Oct 31.
PubMed 25361436

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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Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, 5-Period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of Atazanavir When Co-Administered With Cobicistat as a Fixed Dose Combination Relative to the Single Agents Following a Light Meal, the Relative Bioavailability of Atazanavir When Co-Administered With Cobicistat as a Fixed Dose Combination Relative to the Single Agents Under Fasted Conditions, and the Effect of Food on the Bioavailability of Atazanavir in the Fixed Dose Combination
ClinicalTrials.gov ID: NCT01837719
Acronym / sponsor ID: Atazanavir / AI424-511
Conditions: Human Immunodeficiency Virus Type 1 (HIV-1)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 23 Apr 2013 (estimated)
Results: Posted 29 Aug 2014

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: 5

Arm	Type	Receives
Treatment A: Atazanavir + Cobicistat coadministered	Experimental	Drug: Atazanavir, Drug: CobicistatParticipants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
Treatment B: Atazanavir/Cobicistat FDC	Experimental	Drug: Atazanavir/Cobicistat FDCParticipants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
Treatment C: Atazanavir + Cobicistat coadministered	Experimental	Drug: Atazanavir, Drug: CobicistatParticipants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
Treatment D: Atazanavir/Cobicistat FDC	Experimental	Drug: Atazanavir/Cobicistat FDCParticipants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
Treatment E: Atazanavir/Cobicistat FDC	Experimental	Drug: Atazanavir/Cobicistat FDCParticipants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy men and women, ages 18 to 49 years
Body mass index 18 to 32 kg/m^2, inclusive
Women of childbearing potential (WOCBP) who were not pregnant or breastfeeding
WOCBP and men who are sexually active with WOCBP must use acceptable contraceptive methods

Key exclusion criteria (21 listed)

Any significant acute or chronic medical illness
Current or recent (within 3 months of study drug administration) gastrointestinal tract disease
Any major surgery within 4 weeks of study drug administration
Any gastrointestinal tract surgery (including cholecystectomy) that could have an impact on the absorption of study drug
Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)

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
AtazanavirAlso: BMS-232632300-mg capsule	Drug	Treatment A: Atazanavir + Cobicistat coadministered, Treatment C: Atazanavir + Cobicistat coadministered
Cobicistat150-mg tablet	Drug	Treatment A: Atazanavir + Cobicistat coadministered, Treatment C: Atazanavir + Cobicistat coadministered
Atazanavir/Cobicistat FDCAtazanavir 300-mg/cobicistat 150-mg FDC tablet	Drug	Treatment B: Atazanavir/Cobicistat FDC, Treatment D: Atazanavir/Cobicistat FDC, Treatment E: Atazanavir/Cobicistat FDC

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Atazanavir
Time frame: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)
Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Cmax was derived from plasma concentration versus time data.
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and From Time 0 to Infinity (AUC[INF]) for Atazanavir
Time frame: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)
Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. AUC(0-T) and AUC(INF) were derived from plasma concentration versus time data.

10 secondary outcomes

Number of Participants Who Died and With Serious Adverse Events (SAEs)
Time frame: On Day 24 or 31
Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests
Time frame: At Screening and on Days -1,4, 11, 18, and 31 (study discharge)
Number of Participants With Out-of-range Intervals on Electrocardiogram (ECG) Findings
Time frame: At screening; on Day -1; predose and 4 hours postdose on Days 1, 18, 15, 22, and 29; and at study discharge (Day 31)
Time of Maximum Observed Concentration (Tmax) of Atazanavir
Time frame: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)
Observed Concentration at 24 Hours (C24) of Atazanavir
Time frame: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)
Apparent Terminal Half-life (T-HALF) of Atazanavir
Time frame: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)
Maximum Observed Plasma Concentration (Cmax) of Cobicistat
Time frame: Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)
Time of Maximum Observed Concentration (Tmax) of Cobicistat
Time frame: Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)
Area Under the Concentration Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and Area Under the Concentration Curve From Time 0 to Infinity (AUC[INF]) of Cobicistat
Time frame: Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)
T-HALF of Cobicistat
Time frame: Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)

Results and safety

Results posted to the registry on 29 Aug 2014, 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 Who Received Treatment	64	64

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Atazanavir

Time frame: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose). Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment A: Atazanavir + Cobicistat Coadministered n = 63	Treatment B: Atazanavir/Cobicistat FDC n = 62	Treatment C: Atazanavir + Cobicistat Coadministered n = 63	Treatment D: Atazanavir/Cobicistat FDC n = 63	Treatment E: Atazanavir/Cobicistat FDC n = 30
Value	3832 (39)	4104 (32)	2585 (45)	2941 (44)	2545 (43)

Treatment A: Atazanavir + Cobicistat Coadministered vs Treatment B: Atazanavir/Cobicistat FDC: Geometric mean ratio: 1.073 (90% CI 1.012 to 1.137), Mixed Models Analysis
Treatment B: Atazanavir/Cobicistat FDC vs Treatment D: Atazanavir/Cobicistat FDC: Geometric mean ratio: 1.423 (90% CI 1.273 to 1.590), Mixed Models Analysis
Treatment C: Atazanavir + Cobicistat Coadministered vs Treatment D: Atazanavir/Cobicistat FDC: Geometric mean ratio: 1.137 (90% CI 1.000 to 1.292), Mixed Models Analysis

Population analysed: All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.

Primary outcome: Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and From Time 0 to Infinity (AUC[INF]) for Atazanavir

Measure	Treatment A: Atazanavir + Cobicistat Coadministered n = 63	Treatment B: Atazanavir/Cobicistat FDC n = 62	Treatment C: Atazanavir + Cobicistat Coadministered n = 63	Treatment D: Atazanavir/Cobicistat FDC n = 63	Treatment E: Atazanavir/Cobicistat FDC n = 30
AUC(0-T)	32775 (38)	34905 (32)	25017 (46)	27875 (41)	25873 (40)
AUC(0-INF)	33523 (39)	35673 (32)	25547 (47)	28378 (42)	26510 (40)

Treatment A: Atazanavir + Cobicistat Coadministered vs Treatment B: Atazanavir/Cobicistat FDC: Geometric mean ratio: 1.065 (90% CI 1.012 to 1.120), Mixed Models Analysis
Treatment B: Atazanavir/Cobicistat FDC vs Treatment D: Atazanavir/Cobicistat FDC: Geometric mean ratio: 1.275 (90% CI 1.166 to 1.393), Mixed Models Analysis
Treatment C: Atazanavir + Cobicistat Coadministered vs Treatment D: Atazanavir/Cobicistat FDC: Geometric mean ratio: 1.113 (90% CI 0.993 to 1.248), Mixed Models Analysis

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A: Atazanavir + Cobicistat Coadministered	0 of 64 (0%)	1 of 64 (1.6%)	Not reported
Treatment B: Atazanavir/Cobicistat FDC	0 of 64 (0%)	3 of 64 (4.7%)	Not reported
Treatment C: Atazanavir + Cobicistat Coadministered	0 of 63 (0%)	0 of 63 (0%)	Not reported
Treatment D: Atazanavir/Cobicistat FDC	0 of 63 (0%)	0 of 63 (0%)	Not reported
Treatment E: Atazanavir/Cobicistat FDC	0 of 31 (0%)	0 of 31 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25361436Sevinsky H, Tao X, Wang R, Ravindran P, Sims K, Xu X, Jariwala N, Bertz R. A randomized trial in healthy subjects to assess the bioequivalence of an atazanavir/cobicistat fixed-dose combination tablet versus administration as separate agents. Antivir Ther. 2015;20(5):493-500. doi: 10.3851/IMP2913. Epub 2014 Oct 31.

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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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

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 Atazanavir, Cobicistat and Atazanavir/Cobicistat FDC in people with Human Immunodeficiency Virus Type 1 (HIV-1), run by Bristol-Myers Squibb 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 21 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 29 Aug 2014. 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 29 Aug 2014). 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?

Maximum Observed Plasma Concentration (Cmax) of Atazanavir (time frame: Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)). 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 NCT01837719, 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 29 Aug 2014.