HIVNCT01339403

Kaiser Permanente HIV Cohort Study

An observational study of HIV and AIDS, run by ViiV Healthcare.

Completed

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

Trial summary

Human Immunodeficiency Virus (HIV) infected patients in the Kaiser Permanente HIV registry wil be followed in the usual clinical care to estimate the rates of specified clinical events. The rates will be stratified by relevant characteristics like age, CD4 counts, HIV Viral Load (VL), HIV medication history. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV, AIDS
What is being tested?: non-interventional trial
How many people: 282,368 participants
Where: No sites listed yet
Study dates: Feb 2009to Oct 2013
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: HIV infected patients in the HIV Registry of Kasier Permanente Northern and Southern California and a matched cohort of non-HIV infected patients in Kaiser Permanente

Who may be able to join

HIV infection.

Who cannot join

None

About this study

Official title: Hiv Infection, Antiretroviral Therapy Use And Other Predictors Of Selected Clinical Events In Kaiser Permanente

Read the detailed description

All HIV infected patients in the database will be included without any sampling. A random sample of non-HIV infected patients will be included as comparator.

Conditions: HIV, AIDS
Being tested: non-interventional trial
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.

non-interventional trialOther
No study specific intervention, non-interventional trial
non-interventional trialOther
No study specific intervention, non-interventional trial

Study groups in NCT01339403
Study group	Role	What they receive
HIV infected		No study specific intervention, non-interventional trial Receives: Other: non-interventional trial
HIV-uninfected		No study specific intervention, non-interventional trial Receives: Other: non-interventional trial

What is being measured

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

Incidence Rate of Malignancies
Incidence rate of malignancies was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were Kaiser Permanente (KP) member from the date of HIV care initiation at that institution or January 1, 1996 for KP Northern California(KPNC) and January 1, 2000 for KP Southern California(KPSC) if in care prior to this date. Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies.AIDS-defining malignancies included invasive cervical cancer,invasive non-Hodgkin's lymphoma and kaposi's sarcoma;non-AIDS defining malignancies cancers ascertained from the KP cancer registries.Overall data for non-AIDS and AIDS defining malignancies, along with individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100,000 person-years.
Measured: Up to Week 835
Incidence Rate of Myocardial Infarction and Ischemia
Incidence rate of cardiovascular (CVS)events including myocardial infarction (MI) and ischemia was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
Measured: Up to Week 835
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Incidence rate of AIDS-defining opportunistic infections (OI) was calculated as the number of events divided by person-time.Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1,1996 for KPNC and January 1,2000 for KPSC if in care prior to this date.OI were those that occurred on immune-compromised participants.AIDS-defining infections included:wasting syndrome;pneumocystis jirovecii pneumonia;recurrent pneumonia;cytomegalovirus;HIV-related encephalopathy;esophageal candidiasis;mycobacterium avium complex;cryptococcosis;mycobacterium tuberculosis;progressive multifocal leukoencephalopathy;lung candidiasis;toxoplasmosis of brain;coccidiomycosis;histoplasmosis;recurrent salmonella septicemia;chronic isosporiasis;cryptosporidiosis.Incidence rate was computed as the number of events per 100,000 person-years.
Measured: Up to Week 835
Incidence Rate of Liver Failure
Incidence rate of liver failure was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
Measured: Up to Week 835
Incidence Rate of Liver Related Death
Incidence rate of liver related death was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
Measured: Up to Week 835
Incidence Rate of Rhabdomyolysis
Incidence rate of Rhabdomyolysis was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
Measured: Up to Week 835
Incidence Rate of All-Cause Mortality
Incidence rate of all-cause mortality was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
Measured: Up to Week 835
Incidence Rate of Viral Encephalitis
Incidence rate of viral encephalitis (VE) was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years. The participants with viral encephalitis were followed-up up to 31st December 2009 (730 Weeks).
Measured: Up to Week 730

Timeline

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

Feb 2009Oct 2013

First posted20 Apr 2011 (estimated)
Study startFeb 2009
Primary completionOct 2013
Study completionOct 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.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by ViiV HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 282,368 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01339403
Sponsor's protocol ID: A4001105
Status last verified: Apr 2015
First submitted: 16 Mar 2011
Last updated: 3 Apr 2015
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 HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hiv Infection, Antiretroviral Therapy Use And Other Predictors Of Selected Clinical Events In Kaiser Permanente
ClinicalTrials.gov ID: NCT01339403
Acronym / sponsor ID: A4001105
Conditions: HIV, AIDS
Study type: Observational
Recruitment status: Completed
Enrolment: 282,368 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: Kaiser Permanente, Pfizer
Study start: Feb 2009
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 20 Apr 2011 (estimated)
Results: Posted 3 Apr 2015

Clinical summary

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

Detailed description

All HIV infected patients in the database will be included without any sampling. A random sample of non-HIV infected patients will be included as comparator.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
HIV infected	–	Other: non-interventional trialNo study specific intervention, non-interventional trial
HIV-uninfected	–	Other: non-interventional trialNo study specific intervention, non-interventional trial

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: HIV infected patients in the HIV Registry of Kasier Permanente Northern and Southern California and a matched cohort of non-HIV infected patients in Kaiser Permanente

Key inclusion criteria (1 listed)

HIV infection.

Key exclusion criteria (1 listed)

None

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
non-interventional trialNo study specific intervention, non-interventional trial	Other	HIV infected
non-interventional trialNo study specific intervention, non-interventional trial	Other	HIV-uninfected

Primary outcome

Incidence Rate of Malignancies
Time frame: Up to Week 835
Incidence rate of malignancies was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were Kaiser Permanente (KP) member from the date of HIV care initiation at that institution or January 1, 1996 for KP Northern California(KPNC) and January 1, 2000 for KP Southern California(KPSC) if in care prior to this date. Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies.AIDS-defining malignancies included invasive cervical cancer,invasive non-Hodgkin's lymphoma and kaposi's sarcoma;non-AIDS defining malignancies cancers ascertained from the KP cancer registries.Overall data for non-AIDS and AIDS defining malignancies, along with individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100,000 person-years.
Incidence Rate of Myocardial Infarction and Ischemia
Time frame: Up to Week 835
Incidence rate of cardiovascular (CVS)events including myocardial infarction (MI) and ischemia was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Time frame: Up to Week 835
Incidence rate of AIDS-defining opportunistic infections (OI) was calculated as the number of events divided by person-time.Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1,1996 for KPNC and January 1,2000 for KPSC if in care prior to this date.OI were those that occurred on immune-compromised participants.AIDS-defining infections included:wasting syndrome;pneumocystis jirovecii pneumonia;recurrent pneumonia;cytomegalovirus;HIV-related encephalopathy;esophageal candidiasis;mycobacterium avium complex;cryptococcosis;mycobacterium tuberculosis;progressive multifocal leukoencephalopathy;lung candidiasis;toxoplasmosis of brain;coccidiomycosis;histoplasmosis;recurrent salmonella septicemia;chronic isosporiasis;cryptosporidiosis.Incidence rate was computed as the number of events per 100,000 person-years.
Incidence Rate of Liver Failure
Time frame: Up to Week 835
Incidence rate of liver failure was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
Incidence Rate of Liver Related Death
Time frame: Up to Week 835
Incidence rate of liver related death was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
Incidence Rate of Rhabdomyolysis
Time frame: Up to Week 835
Incidence rate of Rhabdomyolysis was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
Incidence Rate of All-Cause Mortality
Time frame: Up to Week 835
Incidence rate of all-cause mortality was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
Incidence Rate of Viral Encephalitis
Time frame: Up to Week 730
Incidence rate of viral encephalitis (VE) was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years. The participants with viral encephalitis were followed-up up to 31st December 2009 (730 Weeks).

Results and safety

Results posted to the registry on 3 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: HIV Infected	24,768	24,768
Cohort 2: HIV Uninfected	257,600	257,600

Primary outcome: Incidence Rate of Malignancies

Time frame: Up to Week 835. Number. Unit: malignancies per 100,000 person-years

Measure	Cohort 1: HIV Infected n = 24768	Cohort 2: HIV Uninfected n = 257600
Kaposi's sarcoma	513	3
Invasive non-Hodgkin's lymphoma	238	20
Invasive cervical cancer	25	7
Non-AIDS-defining cancer	633	384
AIDS-defining cancer	740	23

Cohort 1: HIV Infected vs Cohort 2: HIV Uninfected: Rate ratio: 166.1 (95% CI 123.4 to 223.5), p <0.001, Poisson Regression
Cohort 1: HIV Infected vs Cohort 2: HIV Uninfected: Rate ratio: 12.1 (95% CI 10.3 to 14.2), p <0.001, Poisson Regression
Cohort 1: HIV Infected vs Cohort 2: HIV Uninfected: Rate ratio: 3.4 (95% CI 1.0 to 12.3), p = 0.059, Poisson Regression

Population analysed: Analysis population included all participants enrolled in the study.

Primary outcome: Incidence Rate of Myocardial Infarction and Ischemia

Time frame: Up to Week 835. Number. Unit: CVS events per 100,000 person-years

Measure	Cohort 1: HIV Infected n = 24768	Cohort 2: HIV Uninfected n = 257600
Value	435	313

Cohort 1: HIV Infected vs Cohort 2: HIV Uninfected: Rate ratio: 1.4 (95% CI 1.3 to 1.5), p <0.001, Poisson Regression

Population analysed: Analysis population included all participants enrolled in the study.

Primary outcome: Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections

Time frame: Up to Week 835. Number. Unit: infections per 100,000 person-years

Measure	Cohort 1: HIV Infected n = 24768	Cohort 2: HIV Uninfected n = 257600
Wasting syndrome	1002	15
Pneumocystis jirovecii pneumonia	760	2
Recurrent pneumonia	640	74
Cytomegalovirus	440	5
HIV-related Encephalopathy	405	NA
Esophageal Candidiasis	383	6
Mycobacterium avium complex	259	3
Cryptococcosis	187	1

Cohort 1: HIV Infected vs Cohort 2: HIV Uninfected: Rate ratio: 65.7 (95% CI 57.1 to 75.7), p <0.001, Poisson Regression
Cohort 1: HIV Infected vs Cohort 2: HIV Uninfected: Rate ratio: 428.5 (95% CI 292.2 to 628.5), p <0.001, Poisson Regression
Cohort 1: HIV Infected vs Cohort 2: HIV Uninfected: Rate ratio: 8.7 (95% CI 7.9 to 9.5), p <0.001, Poisson Regression

Population analysed: Analysis population included all participants enrolled in the study.

Primary outcome: Incidence Rate of Liver Failure

Time frame: Up to Week 835. Number. Unit: liver failure per 100,000 person-years

Measure	Cohort 1: HIV Infected n = 24768	Cohort 2: HIV Uninfected n = 257600
Value	492	105

Cohort 1: HIV Infected vs Cohort 2: HIV Uninfected: Rate ratio: 4.7 (95% CI 4.3 to 5.1), p <0.001, Poisson Regression

Population analysed: Analysis population included all participants enrolled in the study.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: HIV Infected	0 of 0	0 of 0	Not reported
Cohort 2: HIV Uninfected	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Designation of endpoints was based on study team's inputs, as the endpoints were not prioritized in the study protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of HIV and AIDS, run by ViiV Healthcare.

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 3 Apr 2015. 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 3 Apr 2015). 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?

Incidence Rate of Malignancies (time frame: Up to Week 835). The study lists 8 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 NCT01339403.

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 3 Apr 2015.