HIVPhase 4NCT01232127

Effects of Famotidine on the Pharmacokinetics of Atazanavir When Coadministered to Participants With HIV Infection

A Phase 4 study testing Atazanavir, Ritonavir and Tenofovir (TDF) in people with HIV, run by Bristol-Myers Squibb at 2 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to assess the effects of famotidine, given twice daily, on atazanavir administered with ritonavir and tenofovir in HIV-infected participants. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: HIV
What is being tested?: Atazanavir, Ritonavir and Tenofovir (TDF)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 2 sitesin 2 countries
Study dates: Feb 2011to Jun 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females, 18 to 65 years of age, with HIV infection and a body mass index of 18.0 to 35.0 kg/m^2
HIV-infected participants receiving a treatment regimen containing only atazanavir/ritonavir, 300/100 mg once daily (QD) + tenofovir, 300 mg QD + at least 1 other nucleotide reverse transcriptase inhibitor continuously for at least 3 months prior to study day 1
Plasma HIV RNA levels of <50 copies/mL and a CD4 count >200 cells/mm^3.
No history of virologic failure on a protease inhibitor (PI), documented phenotypic PI resistance, or primary PI mutations, according to International AIDS Society recommendations
No documented phenotypic resistance to atazanavir or primary genotypic mutations causing resistance to atazanavir
Women of childbearing potential who were not nursing or pregnant and were using an acceptable method of contraception for at least 4 weeks before dosing, during the study, and for 8 weeks from the last dose of study drug.

Show all 9Show fewer

Women with a negative pregnancy test result within 24 hours prior to dosing with study medication
Women not breastfeeding
Men willing or able to agree to practice barrier contraception for the duration of the study and at least 3 months after dosing.

Who cannot join

Any history of CD4 cell count <50 cells/mm^3
Previously documented phenotypic or genotypic resistance to any of the currently prescribed NRTIs
Any significant acute illness within 6 months of study day 1 or chronic medical illness unless stable or controlled by a nonprohibited medication
Any major surgery within 4 weeks of study day 1
Any gastrointestinal surgery that could impact upon the absorption of any study drug
Inability to be venipunctured and/or tolerate venous access

Show all 18Show fewer

History of Gilbert's syndrome, hemophilia, chronic pancreatitis, hypochlorhydria, achlorhydria, clinically relevant gastroesophageal reflux disease, hiatal hernia, or peptic/gastric ulcer disease
Intractable diarrhea (≥ 6 loose stools/day for at least 7 consecutive days) within 30 days prior to study day 1
Recent (within 6 months prior to study day 1) drug or alcohol abuse
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG)
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations, which would not be expected for the extent of HIV disease
Any of the following on 12-lead ECG prior to dosing on study day 1, confirmed by repeat: PR ≥ 210 msec; QRS ≥ 120 msec; QT ≥ 500 msec; QTcF ≥ 450 msec
Second- or third-degree A-V block or clinically relevant ECG abnormalities
Positive urine screen for drugs of abuse at screening or prior to dosing without a valid prescription. Positive urine drug screen for cannabinoids with or without a prescription is not exclusionary
Creatinine clearance, as estimated by method of Cockcroft and Gault, less than 60 mL/min
Liver enzyme levels > 3* the upper limit of normal (ULN) prior to dosing on study day 1
Total bilirubin level >10*ULN prior to study day 1
Positive blood screen for hepatitis B surface antigen or hepatitis C antibody.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Germany1 site

Local Institution
Berlin, 14050

Other trials in Germany

United Kingdom1 site

Local Institution
London, Greater London, SW10 9NH

Other trials in United Kingdom

About this study

Official title: Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine on the Pharmacokinetics of Atazanavir in HIV-Infected Subjects Receiving Atazanavir With Ritonavir and Tenofovir

The purpose of this study is to assess the effects of famotidine, given twice daily, on atazanavir administered with ritonavir and tenofovir in HIV-infected participants.

Read the detailed description

This protocol was designed to compare the pharmacokinetic parameters of atazanavir administered as atazanavir/ritonavir, 400/100 mg once daily (QD), plus famotidine, 20 mg and 40 mg twice daily, with the parameters found at the usual clinical dose of atazanavir/ritonavir, 300/100 mg QD, without famotidine in HIV-infected participants receiving tenofovir disoproxil fumarate and at least 1 other nucleoside reverse transcriptase inhibitor.

Conditions: HIV
Being tested: Atazanavir, Ritonavir, Tenofovir (TDF), Nucleoside Reverse Transcriptase Inhibitor (NRTI), Famotidine (FAM)

What participants receive

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

AtazanavirDrug
Also called Reyataz, BMS-232632
Capsule, oral, 300 mg, once daily, 10 days
AtazanavirDrug
Also called Reyataz, BMS-232632
Capsule, oral, 400 mg, once daily, 7 days
RitonavirDrug
Capsule, oral, 100 mg, once daily, 10 days
RitonavirDrug
Capsule, oral, 100 mg, once daily, 7 days
Tenofovir (TDF)Drug
Capsule, oral, 300 mg, once daily, 10 days
Tenofovir (TDF)Drug
Capsule, oral, 300 mg, once daily, 7 days
Nucleoside Reverse Transcriptase Inhibitor (NRTI)Drug
Oral, 10 days
Nucleoside Reverse Transcriptase Inhibitor (NRTI)Drug
Oral, 7 days
Famotidine (FAM)Drug
Tablet, oral, 20 mg, twice daily, 7 days
Famotidine (FAM)Drug
Tablet, oral, 40 mg, twice daily, 7 days

Study groups in NCT01232127
Study group	Role	What they receive
Atazanavir/ritonavir (300/100 mg) + TDF + ≥ 1 NRTI	Other	The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs. Receives: Drug: Atazanavir; Drug: Ritonavir; Drug: Tenofovir (TDF); Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (20)	Other	FAM=famotidine. The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs. Receives: Drug: Atazanavir; Drug: Ritonavir; Drug: Tenofovir (TDF); Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTI); Drug: Famotidine (FAM)
Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (40)	Other	FAM=famotidine. The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs. Receives: Drug: Atazanavir; Drug: Ritonavir; Drug: Tenofovir (TDF); Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTI); Drug: Famotidine (FAM)

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir
Measured: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir
Measured: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir
Measured: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.

Secondary outcomes (4)

Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Measured: Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.
Number of Participants With Abnormalities in Vital Signs
Vital signs include temperature, respiratory rate, seated blood pressure, and heart rate.
Measured: Days 1, 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings
ECG findings include heart rate, ECG intervals (including PR, QRS, QT, and corrections to QT using both Bazett's and Fridericia's formulae), and Investigator-identified ECG abnormalities.
Measured: Days 1 and 25 (end of study) and at study discharge for those who discontinued prematurely.
Number of Participants With Abnormalities in Laboratory Test Results
PreRX=pretreatment; ULN=upper limit of normal. Neutrophils, (absolute), low (10*3 c/uL): <0.85*PreRx, if PreRx <1.5; <1.5 if PreRx ≥1.5. Alanine aminotransferase, high (U/L): >1.25*PreRx if PreRx >ULN; >1.25*ULN if PreRx ≤ULN. Bilirubin, direct (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN. Bilirubin, total (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN.
Measured: Days 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.

Timeline

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

Feb 2011Jun 2011

First posted2 Nov 2010 (estimated)
Study startFeb 2011
Primary completionJun 2011
Study 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 HIVStudies 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 4
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01232127
Sponsor's protocol ID: AI424-398
Other IDs: 2009-016981-95, 2009
Status last verified: Aug 2012
First submitted: 29 Oct 2010
Last updated: 31 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine on the Pharmacokinetics of Atazanavir in HIV-Infected Subjects Receiving Atazanavir With Ritonavir and Tenofovir
ClinicalTrials.gov ID: NCT01232127
Acronym / sponsor ID: AI424-398
Conditions: HIV
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 2 Nov 2010 (estimated)
Results: Posted 28 Aug 2012

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 assess the effects of famotidine, given twice daily, on atazanavir administered with ritonavir and tenofovir in HIV-infected participants.

Detailed description

Study design

Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Atazanavir/ritonavir (300/100 mg) + TDF + ≥ 1 NRTI	Other	Drug: Atazanavir, Drug: Ritonavir, Drug: Tenofovir (TDF), Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTI)The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs.
Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (20)	Other	Drug: Atazanavir, Drug: Ritonavir, Drug: Tenofovir (TDF), Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTI), Drug: Famotidine (FAM)FAM=famotidine. The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs.
Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (40)	Other	Drug: Atazanavir, Drug: Ritonavir, Drug: Tenofovir (TDF), Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTI), Drug: Famotidine (FAM)FAM=famotidine. The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Males and females, 18 to 65 years of age, with HIV infection and a body mass index of 18.0 to 35.0 kg/m^2
HIV-infected participants receiving a treatment regimen containing only atazanavir/ritonavir, 300/100 mg once daily (QD) + tenofovir, 300 mg QD + at least 1 other nucleotide reverse transcriptase inhibitor continuously for at least 3 months prior to study day 1
Plasma HIV RNA levels of <50 copies/mL and a CD4 count >200 cells/mm^3.
No history of virologic failure on a protease inhibitor (PI), documented phenotypic PI resistance, or primary PI mutations, according to International AIDS Society recommendations
No documented phenotypic resistance to atazanavir or primary genotypic mutations causing resistance to atazanavir

Key exclusion criteria (18 listed)

Any history of CD4 cell count <50 cells/mm^3
Previously documented phenotypic or genotypic resistance to any of the currently prescribed NRTIs
Any significant acute illness within 6 months of study day 1 or chronic medical illness unless stable or controlled by a nonprohibited medication
Any major surgery within 4 weeks of study day 1
Any gastrointestinal surgery that could impact upon the absorption of any 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
AtazanavirAlso: Reyataz, BMS-232632Capsule, oral, 300 mg, once daily, 10 days	Drug	Atazanavir/ritonavir (300/100 mg) + TDF + ≥ 1 NRTI
AtazanavirAlso: Reyataz, BMS-232632Capsule, oral, 400 mg, once daily, 7 days	Drug	Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (20), Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (40)
RitonavirCapsule, oral, 100 mg, once daily, 10 days	Drug	Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (20), Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (40)
RitonavirCapsule, oral, 100 mg, once daily, 7 days	Drug	Atazanavir/ritonavir (300/100 mg) + TDF + ≥ 1 NRTI
Tenofovir (TDF)Capsule, oral, 300 mg, once daily, 10 days	Drug	Atazanavir/ritonavir (300/100 mg) + TDF + ≥ 1 NRTI
Tenofovir (TDF)Capsule, oral, 300 mg, once daily, 7 days	Drug	Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (20), Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (40)
Nucleoside Reverse Transcriptase Inhibitor (NRTI)Oral, 10 days	Drug	Atazanavir/ritonavir (300/100 mg) + TDF + ≥ 1 NRTI
Nucleoside Reverse Transcriptase Inhibitor (NRTI)Oral, 7 days	Drug	Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (20), Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (40)
Famotidine (FAM)Tablet, oral, 20 mg, twice daily, 7 days	Drug	Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (20)
Famotidine (FAM)Tablet, oral, 40 mg, twice daily, 7 days	Drug	Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (40)

Primary outcome

Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir
Time frame: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir
Time frame: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir
Time frame: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.

4 secondary outcomes

Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest
Time frame: Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.
Number of Participants With Abnormalities in Vital Signs
Time frame: Days 1, 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings
Time frame: Days 1 and 25 (end of study) and at study discharge for those who discontinued prematurely.
Number of Participants With Abnormalities in Laboratory Test Results
Time frame: Days 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.

Results and safety

Results posted to the registry on 28 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI	25	24
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)	0	0
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)	0	0

Primary outcome: Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir

Time frame: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI n = 25	Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) n = 24	Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) n = 24
Atazanavir Cmax	3512 (35.4)	4131 (37.7)	3322 (45.2)
Atazanavir Ctrough	496 (50.9)	602 (60.3)	494 (59.4)
Ritonavir Cmax	1141 (30.5)	1148 (29.8)	1096 (36.1)
Ritonavir Ctrough	45.8 (58.7)	49.2 (66.8)	47.3 (53.4)

Population analysed: Participants who received study drug and had adequate PK profiles.

Primary outcome: Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir

Time frame: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.. Median (Full Range). Unit: Hours

Measure	Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI n = 25	Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) n = 24	Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) n = 24
Atazanavir Tmax	3.0 (2.0 to 4.0)	3.0 (2.0 to 4.0)	3.0 (2.0 to 4.10)
Ritonavir Tmax	4.0 (2.0 to 4.2)	4.00 (2.0 to 6.0)	4.0 (2.0 to 6.0)

Population analysed: Participants who received study drug and had adequate PK profiles.

Primary outcome: Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir

Time frame: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI n = 25	Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) n = 24	Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) n = 24
Atazanavir AUC	32562 (37.7)	37894 (40.7)	31481 (48.8)
Ritonavir AUC	7317 (35.6)	7430 (32.4)	7052 (36.7)

Population analysed: Participants who received study drug and had adequate PK profiles.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI	0 of 25 (0%)	4 of 25 (16%)	Not reported
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)	0 of 25 (0%)	6 of 25 (24%)	Not reported
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)	0 of 24 (0%)	1 of 24 (4.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atazanavir, Ritonavir and Tenofovir (TDF) in people with HIV, run by Bristol-Myers Squibb at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 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 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 28 Aug 2012). 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) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir (time frame: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.). The study lists 3 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 NCT01232127.

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 Aug 2012.