HIV-1NCT00850395

Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection

An observational study of HIV-1, run by ViiV Healthcare.

Completed

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

Trial summary

Aim of the study is to gain more knowledge about efficacy of CELSENTRI® in daily clinical practice and obtain information about the quality of life of patients using CELSENTRI®. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1
What is being tested?: maraviroc
How many people: 79 participants
Where: No sites listed yet
Study dates: Jul 2009to Oct 2011
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-1 infected, therapy-experienced patients, CCR5-tropic virus,

Who may be able to join

HIV-1 infection. CCR-5 tropic virus. Therapy experienced patient,

Who cannot join

X4 or D/M tropic virus. Therapy-naive patients.

About this study

Official title: Non-Interventional Study Of Celsentri® In Treatment Experienced Patients Infected With CCR5 Tropic HIV-1

Aim of the study is to gain more knowledge about efficacy of CELSENTRI® in daily clinical practice and obtain information about the quality of life of patients using CELSENTRI®.

Read the detailed description

Non interventional study, inclusion and exclusion criteria defined by the labelling of Celsentri (Maraviroc).

Conditions: HIV-1
Being tested: maraviroc
Keywords: HIV-1, non-interventional, CCR-5 tropic virus, therapy experienced patients

What participants receive

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

maravirocDrug
Also called Selzentry, Celsentri
No intervention; any procedure at the discretion of the treating physician, in line with the SmPC

Study groups in NCT00850395
Study group	Role	What they receive
1		Non-Interventional Receives: Drug: maraviroc

What is being measured

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

Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3
Measured: Baseline, Month 3
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6
Measured: Baseline, Month 6
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12
Measured: Baseline, Month 12
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3
Measured: Baseline, Month 3
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6
Measured: Baseline, Month 6
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12
Measured: Baseline, Month 12
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3
Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Measured: Month 3
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6
Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Measured: Month 6
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12
Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Measured: Month 12

Secondary outcomes (4)

Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12
SDM consists of the 20 items questionnaire, each item rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). A positive change from baseline indicates a decline in a participant's quality of life over that period.
Measured: Baseline, Months 6, 12
Number of Participants With Human Immunodeficiency Virus (HIV) Response
Response was defined as a HIV-1 RNA count of less than 50 copies/mL.
Measured: Month 12
Physician's Assessment of Efficacy
Number of participants with each grade of efficacy as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.
Measured: Month 12
Number of Participants Taking Concomitant Therapy
Participants taking HIV/AIDS concomitant medication at Month 12, at Baseline and Month 12 were reported. It included Emtricitabine/tenofovir disoproxil fumarate(FTC/TDF),Raltegravir(RAL), Ritonavir (RTV), Darunavir(DRV), Kaletra, Atazanavir sulfate(ATV), Abacavir sulfate/lamivudine(ABC/LAM), Tenofovir disoproxil fumarate(TDF), Etravirine(ETR), Lamivudine (LAM), Zidovudine W/lamivudine(ZDV W/LAM), Nevirapine(NVP), Saquinavir mesilate(SQV), Trizivir(TZV), Zidovudine(ZDV), Abacavir sulfate(ABC), Emtricitabine(FTC),Entecavir(ETV).
Measured: Baseline, Month 12

Timeline

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

Jul 2009Oct 2011

First posted25 Feb 2009 (estimated)
Study startJul 2009
Primary completionOct 2011
Study completionOct 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 HIV-1Studies 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
Time perspective: Prospective
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00850395
Sponsor's protocol ID: A4001070
Other IDs: CELTROP
Status last verified: Nov 2012
First submitted: 23 Feb 2009
Last updated: 7 Nov 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?

Official record

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

All HIV-1 trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Interventional Study Of Celsentri® In Treatment Experienced Patients Infected With CCR5 Tropic HIV-1
ClinicalTrials.gov ID: NCT00850395
Acronym / sponsor ID: A4001070
Conditions: HIV-1
Keywords: HIV-1, non-interventional, CCR-5 tropic virus, therapy experienced patients
Study type: Observational
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Jul 2009
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 25 Feb 2009 (estimated)
Results: Posted 15 Oct 2012

Clinical summary

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

Aim of the study is to gain more knowledge about efficacy of CELSENTRI® in daily clinical practice and obtain information about the quality of life of patients using CELSENTRI®.

Detailed description

Non interventional study, inclusion and exclusion criteria defined by the labelling of Celsentri (Maraviroc).

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	Drug: maravirocNon-Interventional

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: HIV-1 infected, therapy-experienced patients, CCR5-tropic virus,

Key inclusion criteria (1 listed)

HIV-1 infection. CCR-5 tropic virus. Therapy experienced patient,

Key exclusion criteria (1 listed)

X4 or D/M tropic virus. Therapy-naive patients.

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
maravirocAlso: Selzentry, CelsentriNo intervention; any procedure at the discretion of the treating physician, in line with the SmPC	Drug	1

Primary outcome

Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3
Time frame: Baseline, Month 3
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6
Time frame: Baseline, Month 6
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12
Time frame: Baseline, Month 12
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3
Time frame: Baseline, Month 3
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6
Time frame: Baseline, Month 6
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12
Time frame: Baseline, Month 12
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3
Time frame: Month 3
Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6
Time frame: Month 6
Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12
Time frame: Month 12
Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).

4 secondary outcomes

Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12
Time frame: Baseline, Months 6, 12
Number of Participants With Human Immunodeficiency Virus (HIV) Response
Time frame: Month 12
Physician's Assessment of Efficacy
Time frame: Month 12
Number of Participants Taking Concomitant Therapy
Time frame: Baseline, Month 12

Results and safety

Results posted to the registry on 15 Oct 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
Maraviroc	79	69

Primary outcome: Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3

Time frame: Baseline, Month 3. Mean (Standard Deviation). Unit: copies/mL

Measure	Maraviroc n = 75
Value	-1.10 (1.530)

Population analysed: Full Analysis Set (FAS) population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Primary outcome: Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6

Time frame: Baseline, Month 6. Mean (Standard Deviation). Unit: copies/mL

Measure	Maraviroc n = 74
Value	-1.15 (1.579)

Population analysed: FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Primary outcome: Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12

Time frame: Baseline, Month 12. Mean (Standard Deviation). Unit: copies/mL

Measure	Maraviroc n = 79
Value	-0.95 (1.571)

Population analysed: FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.

Primary outcome: Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3

Time frame: Baseline, Month 3. Mean (Standard Deviation). Unit: cells/mcL

Measure	Maraviroc n = 75
Value	74.31 (162.18)

4 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
Maraviroc	3 of 79 (3.8%)	4 of 79 (5.1%)	Not reported

Limitations and caveats (from the sponsor): Designation of outcomes as primary and secondary was based on study team input as study did not specify primary or secondary outcome measures.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2012.
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.

Related trials for HIV-1

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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-1, 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 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 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?

Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3 (time frame: Baseline, Month 3). The study lists 9 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 NCT00850395.

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 Nov 2012.