Infection, Human Immunodeficiency VirusNCT01054586

Fosamprenavir in Pts With Hepatic Impairment

An observational study of Infection, Human Immunodeficiency Virus, 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 years and older
Conditions the study is for: Infection, Human Immunodeficiency Virus
What is being tested?: Intervention A Standard dose, Intervention B Reduced Dose and Intervention C
How many people: 167 participants
Where: No sites listed yet
Study dates: Jan 2009to Mar 2012
Phase: Observational
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The source population is from three HIV patient cohorts; ICONA, HEPAVIH and MASTER cohort in Europe. Data from these cohorts are comprised of the clinical records (or a defined subset thereof) of HIV infected patients. The ICONA Foundation study collects data on HIV infected individuals from 67 infectious disease centres across Italy and has been established since 1997. The ICONA cohort only includes patients who are treatment naïve at initial presentation. HEPAVIH is a cohort of HIV-hepatitis co-infected patients, identified from three other ongoing French HIV cohorts: RIBAVIC, SEROCO and AQUITAINE and an additional 12 clinical departments. The MASTER cohort collects data on HIV infected individuals from centres across Italy and includes treatment-experienced and naive patients.

Who may be able to join

HIV infected patients with or without hepatic impairment coinfected with HBV or HCV who started FPV/RTV-based therapy on or after January 1, 2008. The FPV/RTV exposed patients will be stratified into four groups for analysis (see interventions A-D for label/description above), according to their degree of baseline hepatic impairment, which will be defined according to FPV/RTV dose received (and APRI score for interventions A and D). The LPV/RTV intervention group must have started this therapy at approved standard doses on or after January 1, 2008.

Who cannot join

Receipt of FPV/RTV or LPV/RTV within the year preceding the baseline visit.

About this study

Official title: HI FPV Study: Using Observational Cohorts to Monitor Safety of Fosamprenavir in Patients With Mild/Moderate Hepatic Impairment

APV10017 was a pharmacokinetic study that evaluated the pharmacokinetics, safety and tolerability of fosamprenavir/ritonavir (FPV/RTV) at reduced doses over 14 days in HIV-infected subjects with mild to moderate hepatic impairment (HI). Based on these data, two new regimens have recently been approved by the EMEA and FDA in these patient groups; FPV 700mg BID/RTV 100mg QD for those with mild HI (Child-Pugh score 4-6) and FPV 450mg BID/RTV 100mg QD for those with moderate HI (Child Pugh score 7-9). The Committee for Medicinal Products for Human Use (CHMP) has requested longer-term safety data among this hepatically impaired HIV-infected population who have received the recently updated FPV/RTV dosing regimens.

An observational cohort study will be conducted using routinely collected data in three European HIV patient cohorts with a high proportion of hepatitis co-infected individuals. Patients who received FPV/RTV will be followed to address the following objectives.

Primary: To assess the safety and tolerability of FPV/RTV-based ART in subjects with mild to moderate hepatic impairment.

Secondary: A). To compare the safety and tolerability of FPV/RTV-based ART in subjects with mild to moderate hepatic impairment when compared to FPV/RTV-based ART in hepatitis B (HBV) or hepatitis C (HCV) co-infected subjects with normal hepatic function. B). To compare the safety and tolerability of FPV/RTV-based ART to lopinavir/ritonavir LPV/RTV-based ART in subjects with mild to moderate hepatic impairment.

Read the detailed description

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Conditions: Infection, Human Immunodeficiency Virus
Being tested: Intervention A Standard dose, Intervention B Reduced Dose, Intervention C, Intervention D, Intervention E
Keywords: antiretroviral therapy, hepatic impairment, HIV
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.

Intervention A Standard doseDrug
HIV subjects with HBV or HCV co-infection but normal hepatic function, defined by receipt of FPV 700mg BID/RTV 100mg BID and a baseline AST-platelet ratio index (APRI) score of <2.0.
Intervention B Reduced DoseDrug
HIV subjects with mild hepatic impairment, defined by receipt of the recommended reduced FPV/RTV dose (700mg BID/100mg QD).
Intervention CDrug
HIV subjects with moderate hepatic impairment, defined by receipt of FPV 450mg BID/RTV 100mg QD.
Intervention DDrug
HIV subjects receiving the standard dose of FPV/RTV despite evidence of abnormal hepatic function according to APRI score: HIV subjects with HBV or HCV co-infection, receipt of FPV 700mg BID/RTV 100mg BID and a baseline APRI score of ≥2.0.
Intervention EDrug
HIV subjects coinfected with HBV or HCV who have initiated standard doses of LPV 400mg/RTV 100mg and enrolled in the same cohorts as the FPV/RTV exposed subjects.

Study groups in NCT01054586
Study group	Role	What they receive
HIV pts w/ HBV or HCV, w/ or w/o mild to moderate HI		Patients with HIV coinfected with HBV or HCV with or without mild to moderate HI who are enrolled in one of the participating HIV patient cohorts. These patients will be exposed to FPV/RTV or LPV/RTV. Receives: Drug: Intervention A Standard dose; Drug: Intervention B Reduced Dose; Drug: Intervention C; Drug: Intervention D; Drug: Intervention E

What is being measured

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

Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables
An elevation in ALT is defined as a single value >200 IU/I.
Measured: The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALT
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables
An elevation in ALT is defined as a single value >200 IU/I.
Measured: Incidence of these events was assessed over time during Year 1, censoring patients' follow-up at date of last ALT
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables
An elevation in ALT is defined as a single value >200 IU/I.
Measured: Incidence was assessed over time during Year 1
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts
An elevation in ALT is defined as a single value >200 IU/I.
Measured: Incidence was assessed over time during Year 1

Secondary outcomes (13)

Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables
A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV.
Measured: Incidence was assessed over time during Year 1
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables
A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV.
Measured: Incidence was assessed over time during Year 1
Number of Events of First Discontinuation of FPV/RTV- or LPV/RTV Alone by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts
A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV
Measured: Incidence was assessed over time during Year 1
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only
A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attritubed to adverse events only
Measured: Incidence was assessed over time during Year 1
Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for APRI-score and Other Variables (See Comments)
A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime
Measured: Incidence was assessed over time during Year 1
Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for FIB-score and Other Variables
A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime.
Measured: Incidence was assessed over time during Year 1
Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling Current Values of CD4 and Platelet Counts
A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime.
Measured: Incidence was assessed over time during Year 1
Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only
Defined as the occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only
Measured: Incidence was assessed over time during Year 1
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events
Defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available).
Measured: Incidence was assessed over time during Year 1
Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r
Antiretrovirals discontinued for the first time after starting FPV/r or LPV/r
Measured: Assessed over time during Year 1
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Major reasons for discontinuing one or more drugs in the FPV/r or LPV/r regimen
Measured: Assessed over time during Year 1
Number of Participants for Which the Reason for Discontinuation of One or More Drugs in the FPV/RTV or LPV/RTV Regimen Was Due to Adverse Events Only
Number of participants for which the reason for discontinuation of one or more drugs in the FPV/RTV or LPV/RTV regimen was due to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available)
Measured: The incidence of these events was assessed over time during Year 1
Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures
Incidence rates per 100 person-years of follow-up of study primary outcome. The numbers analyzed in the category titles represent the number of patients with each event. Incidence rate is the number of new cases per population in a given time period, where the denominator is the sum of the person-time of the at-risk population.
Measured: Incidence of these events was assessed over time during Year 1

Timeline

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

Jan 2009Mar 2012

First posted22 Jan 2010 (estimated)
Study startJan 2009
Primary completionMar 2012
Study completionMar 2012

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 Infection, Human Immunodeficiency VirusStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01054586
Sponsor's protocol ID: 111949
Other IDs: WEUKSTV2430, EPI40537
Status last verified: Apr 2013
First submitted: 21 Jan 2010
Last updated: 7 May 2013
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?

Official record

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All Infection, Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HI FPV Study: Using Observational Cohorts to Monitor Safety of Fosamprenavir in Patients With Mild/Moderate Hepatic Impairment
ClinicalTrials.gov ID: NCT01054586
Acronym / sponsor ID: 111949
Conditions: Infection, Human Immunodeficiency Virus
Keywords: antiretroviral therapy, hepatic impairment, HIV
Study type: Observational
Recruitment status: Completed
Enrolment: 167 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 22 Jan 2010 (estimated)
Results: Posted 28 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary: To assess the safety and tolerability of FPV/RTV-based ART in subjects with mild to moderate hepatic impairment.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
HIV pts w/ HBV or HCV, w/ or w/o mild to moderate HI	–	Drug: Intervention A Standard dose, Drug: Intervention B Reduced Dose, Drug: Intervention C, Drug: Intervention D, Drug: Intervention EPatients with HIV coinfected with HBV or HCV with or without mild to moderate HI who are enrolled in one of the participating HIV patient cohorts. These patients will be exposed to FPV/RTV or LPV/RTV.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The source population is from three HIV patient cohorts; ICONA, HEPAVIH and MASTER cohort in Europe. Data from these cohorts are comprised of the clinical records (or a defined subset thereof) of HIV infected patients. The ICONA Foundation study collects data on HIV infected individuals from 67 infectious disease centres across Italy and has been established since 1997. The ICONA cohort only includes patients who are treatment naïve at initial presentation. HEPAVIH is a cohort of HIV-hepatitis co-infected patients, identified from three other ongoing French HIV cohorts: RIBAVIC, SEROCO and AQUITAINE and an additional 12 clinical departments. The MASTER cohort collects data on HIV infected individuals from centres across Italy and includes treatment-experienced and naive patients.

Key inclusion criteria (1 listed)

HIV infected patients with or without hepatic impairment coinfected with HBV or HCV who started FPV/RTV-based therapy on or after January 1, 2008. The FPV/RTV exposed patients will be stratified into four groups for analysis (see interventions A-D for label/description above), according to their degree of baseline hepatic impairment, which will be defined according to FPV/RTV dose received (and APRI score for interventions A and D). The LPV/RTV intervention group must have started this therapy at approved standard doses on or after January 1, 2008.

Key exclusion criteria (1 listed)

Receipt of FPV/RTV or LPV/RTV within the year preceding the baseline visit.

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
Intervention A Standard doseHIV subjects with HBV or HCV co-infection but normal hepatic function, defined by receipt of FPV 700mg BID/RTV 100mg BID and a baseline AST-platelet ratio index (APRI) score of <2.0.	Drug	HIV pts w/ HBV or HCV, w/ or w/o mild to moderate HI
Intervention B Reduced DoseHIV subjects with mild hepatic impairment, defined by receipt of the recommended reduced FPV/RTV dose (700mg BID/100mg QD).	Drug	HIV pts w/ HBV or HCV, w/ or w/o mild to moderate HI
Intervention CHIV subjects with moderate hepatic impairment, defined by receipt of FPV 450mg BID/RTV 100mg QD.	Drug	HIV pts w/ HBV or HCV, w/ or w/o mild to moderate HI
Intervention DHIV subjects receiving the standard dose of FPV/RTV despite evidence of abnormal hepatic function according to APRI score: HIV subjects with HBV or HCV co-infection, receipt of FPV 700mg BID/RTV 100mg BID and a baseline APRI score of ≥2.0.	Drug	HIV pts w/ HBV or HCV, w/ or w/o mild to moderate HI
Intervention EHIV subjects coinfected with HBV or HCV who have initiated standard doses of LPV 400mg/RTV 100mg and enrolled in the same cohorts as the FPV/RTV exposed subjects.	Drug	HIV pts w/ HBV or HCV, w/ or w/o mild to moderate HI

Primary outcome

Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables
Time frame: The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALT
An elevation in ALT is defined as a single value >200 IU/I.
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables
Time frame: Incidence of these events was assessed over time during Year 1, censoring patients' follow-up at date of last ALT
An elevation in ALT is defined as a single value >200 IU/I.
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables
Time frame: Incidence was assessed over time during Year 1
An elevation in ALT is defined as a single value >200 IU/I.
Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts
Time frame: Incidence was assessed over time during Year 1
An elevation in ALT is defined as a single value >200 IU/I.

13 secondary outcomes

Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables
Time frame: Incidence was assessed over time during Year 1
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables
Time frame: Incidence was assessed over time during Year 1
Number of Events of First Discontinuation of FPV/RTV- or LPV/RTV Alone by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts
Time frame: Incidence was assessed over time during Year 1
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only
Time frame: Incidence was assessed over time during Year 1
Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for APRI-score and Other Variables (See Comments)
Time frame: Incidence was assessed over time during Year 1
Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for FIB-score and Other Variables
Time frame: Incidence was assessed over time during Year 1
Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling Current Values of CD4 and Platelet Counts
Time frame: Incidence was assessed over time during Year 1
Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only
Time frame: Incidence was assessed over time during Year 1
Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events
Time frame: Incidence was assessed over time during Year 1
Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r
Time frame: Assessed over time during Year 1
Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen
Time frame: Assessed over time during Year 1
Number of Participants for Which the Reason for Discontinuation of One or More Drugs in the FPV/RTV or LPV/RTV Regimen Was Due to Adverse Events Only
Time frame: The incidence of these events was assessed over time during Year 1
Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures
Time frame: Incidence of these events was assessed over time during Year 1

Results and safety

Results posted to the registry on 28 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FPV 700 mg BID/RTV 100 mg BID	43	43
FPV 700 mg BID/RTV 100 mg QD	15	15
FPV, Other	8	8
LPV, Standard Dose	101	101

Primary outcome: Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables

Time frame: The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALT. Number. Unit: events

Measure	ART naïve n = 69	Not ART naïve n = 98
Value	9	4

ART naïve vs Not ART naïve: Hazard Ratio (HR): 6.10 (95% CI 1.26 to 29.46), p = 0.02, Regression, Cox

Population analysed: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Primary outcome: Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables

Time frame: Incidence of these events was assessed over time during Year 1, censoring patients' follow-up at date of last ALT. Number. Unit: events

Measure	FPV 700 mg BID/RTV 100 mg BID n = 43	FPV 700 mg BID/RTV 100 mg QD n = 15	LPV, Standard Dose n = 101
Value	6	1	6

FPV 700 mg BID/RTV 100 mg BID vs LPV, Standard Dose: Hazard Ratio (HR): 4.12 (95% CI 1.03 to 16.50), p = 0.05, Regression, Cox
FPV 700 mg BID/RTV 100 mg QD vs LPV, Standard Dose: Hazard Ratio (HR): 1.62 (95% CI 0.16 to 16.27), p = 0.68, Regression, Cox

Population analysed: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Primary outcome: Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables

Time frame: Incidence was assessed over time during Year 1. Number. Unit: events

Measure	FPV 700 mg BID/RTV 100 mg BID n = 43	FPV 700 mg BID/RTV 100 mg QD n = 15	LPV, Standard Dose n = 101
Value	6	1	6

FPV 700 mg BID/RTV 100 mg BID vs LPV, Standard Dose: Hazard Ratio (HR): 2.83 (95% CI 0.65 to 12.36), p = 0.17, Regression, Cox
FPV 700 mg BID/RTV 100 mg QD vs LPV, Standard Dose: Hazard Ratio (HR): 1.26 (95% CI 0.12 to 13.33), p = 0.85, Regression, Cox

Population analysed: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Primary outcome: Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts

Time frame: Incidence was assessed over time during Year 1. Number. Unit: events

Measure	FPV 700 mg BID/RTV 100 mg BID n = 43	FPV 700 mg BID/RTV 100 mg QD n = 15	LPV, Standard Dose n = 101
Value	6	1	6

FPV 700 mg BID/RTV 100 mg BID vs LPV, Standard Dose: Hazard Ratio (HR): 3.2 (95% CI 0.94 to 10.82), p = 0.06, Regression, Cox
FPV 700 mg BID/RTV 100 mg QD vs LPV, Standard Dose: Hazard Ratio (HR): 1.06 (95% CI 0.11 to 9.83), p = 0.96, Regression, Cox

Population analysed: HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FPV 700 mg BID/RTV 100 mg BID	0 of 0	0 of 0	Not reported
FPV 700 mg BID/RTV 100 mg QD	0 of 0	0 of 0	Not reported
FPV, Other	0 of 0	0 of 0	Not reported
LPV, Standard Dose	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
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.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

An observational study of Infection, Human Immunodeficiency Virus, 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 1 inclusion and 1 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 7 May 2013. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2011). 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?

Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables (time frame: The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALT). The study lists 4 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 NCT01054586.

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 7 May 2013; AzTrials last refreshed its copy on 7 Nov 2026.