Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection
This study has been completed.
Sponsor:
ViiV Healthcare
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00850395
First received: February 23, 2009
Last updated: November 5, 2012
Last verified: November 2012
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Purpose
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®.
| Condition | Intervention |
|---|---|
|
HIV-1 |
Drug: maraviroc |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Non-Interventional Study Of Celsentri® In Treatment Experienced Patients Infected With CCR5 Tropic HIV-1 |
Resource links provided by NLM:
Further study details as provided by ViiV Healthcare:
Primary Outcome Measures:
- Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
- Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6 [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
- Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
- Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
- Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6 [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
- Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
- Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
- Number of Participants With Human Immunodeficiency Virus (HIV) Response [ Time Frame: Month 12 ] [ Designated as safety issue: No ]Response was defined as a HIV-1 RNA count of less than 50 copies/mL.
- Physician's Assessment of Efficacy [ Time Frame: Month 12 ] [ Designated as safety issue: No ]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.
- Number of Participants Taking Concomitant Therapy [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]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).
| Enrollment: | 79 |
| Study Start Date: | July 2009 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Non-Interventional
|
Drug: maraviroc
No intervention; any procedure at the discretion of the treating physician, in line with the SmPC
Other Name: Selzentry, Celsentri
|
Detailed Description:
Non interventional study, inclusion and exclusion criteria defined by the labelling of Celsentri (Maraviroc).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV-1 infected, therapy-experienced patients, CCR5-tropic virus,
Criteria
Inclusion Criteria:
HIV-1 infection. CCR-5 tropic virus. Therapy experienced patient,
Exclusion Criteria:
X4 or D/M tropic virus. Therapy-naive patients.
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT00850395 History of Changes |
| Other Study ID Numbers: | A4001070, CELTROP |
| Study First Received: | February 23, 2009 |
| Results First Received: | September 11, 2012 |
| Last Updated: | November 5, 2012 |
| Health Authority: | Germany: BfArM |
Keywords provided by ViiV Healthcare:
|
HIV-1 non-interventional CCR-5 tropic virus therapy experienced patients |
ClinicalTrials.gov processed this record on June 13, 2013