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| ID | Type | Description | Link |
|---|---|---|---|
| CELTROP |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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®.
Non interventional study, inclusion and exclusion criteria defined by the labelling of Celsentri (Maraviroc).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Non-Interventional |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maraviroc | Drug | No intervention; any procedure at the discretion of the treating physician, in line with the SmPC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3 | Baseline, Month 3 | |
| Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6 | Baseline, Month 6 | |
| Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12 | Baseline, Month 12 | |
| Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3 | Baseline, Month 3 | |
| Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6 | Baseline, Month 6 | |
| Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12 | 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). | 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). | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
HIV-1 infection. CCR-5 tropic virus. Therapy experienced patient,
Exclusion Criteria:
X4 or D/M tropic virus. Therapy-naive patients.
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HIV-1 infected, therapy-experienced patients, CCR5-tropic virus,
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Maraviroc | Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Maraviroc | Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3 | 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. | Posted | Mean | Standard Deviation | copies/mL | Baseline, Month 3 |
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|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Maraviroc | Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ichthyosis | Congenital, familial and genetic disorders | MedDRA 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
Designation of outcomes as primary and secondary was based on study team input as study did not specify primary or secondary outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| 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). | Month 12 |
| 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. | 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. | 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). | Baseline, Month 12 |
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) | Number of participants evaluable for this measure=78. | Mean | Standard Deviation | copies/milliliter (copies/mL) |
|
| Cluster of Differentiation 4 (CD4+) Cell Counts | Mean | Standard Deviation | cells/microliter (cells/mcL) |
|
| Number of Participants With Centers for Disease Control and Prevention (CDC) Classification | Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C). | Number | participants |
|
| Acquired Immune Deficiency Syndrome Clinical Trials Group Symptom Distress Module(SDM) Overall Score | SDM: 20 items questionnaire, each item rated from 0 to 4, 0=complete absence of symptom and 4=very bothersome symptom. Overall score: sum of scores for each of 20 items of questionnaire, with 0=best health and 80=worst health. A positive change from baseline indicates decline in participant's quality of life. Number of participants evaluable=55. | Mean | Standard Deviation | units on a scale |
|
| Participants |
|
|
| Primary | Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6 | 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. | Posted | Mean | Standard Deviation | copies/mL | Baseline, Month 6 |
|
|
|
| Primary | Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12 | 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. | Posted | Mean | Standard Deviation | copies/mL | Baseline, Month 12 |
|
|
|
| Primary | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3 | 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. | Posted | Mean | Standard Deviation | cells/mcL | Baseline, Month 3 |
|
|
|
| Primary | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6 | 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. | Posted | Mean | Standard Deviation | cells/mcL | Baseline, Month 6 |
|
|
|
| Primary | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12 | 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. | Posted | Mean | Standard Deviation | cells/mcL | Baseline, Month 12 |
|
|
|
| Primary | 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). | 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. | Posted | Number | participants | Month 3 |
|
|
|
| Primary | 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). | 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. | Posted | Number | participants | Month 6 |
|
|
|
| Primary | 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). | 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. | Posted | Number | participants | Month 12 |
|
|
|
| Secondary | 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. | FAS population. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' signifies participants evaluable at specified time point. Missing values were imputed only for Month 12 as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 6, 12 |
|
|
|
| Secondary | Number of Participants With Human Immunodeficiency Virus (HIV) Response | Response was defined as a HIV-1 RNA count of less than 50 copies/mL. | FAS population included all participants who received at least one dose (including partial doses) of study medication. | Posted | Number | participants | Month 12 |
|
|
|
| Secondary | 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. | FAS population included all participants who received at least one dose (including partial doses) of study medication. | Posted | Number | participants | Month 12 |
|
|
|
| Secondary | 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). | FAS population included all participants who received at least one dose (including partial doses) of study medication. | Posted | Number | participants | Baseline, Month 12 |
|
|
|
| 3 |
| 79 |
| 4 |
| 79 |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| Fair |
|
| Poor |
|
| Title | Measurements |
|---|---|
|
| ABC/LAM (Baseline, Month 12) |
|
| ABC/LAM, DRV, RAL (Month 12) |
|
| ABC/LAM, DRV, RAL (Baseline, Month 12) |
|
| ABC/LAM, RAL (Month 12) |
|
| ABC/LAM, RAL (Baseline, Month 12) |
|
| ABC/LAM, RAL, TDF (Month 12) |
|
| ABC/LAM, RAL, TDF (Baseline, Month 12) |
|
| ATV (Month 12) |
|
| ATV (Baseline, Month 12) |
|
| ATV, FTC/TDF (Month 12) |
|
| ATV, FTC/TDF (Baseline, Month 12) |
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| ATV, FTC/TDF, RTV (Month 12) |
|
| ATV, FTC/TDF, RTV (Baseline, Month 12) |
|
| ATV, LAM, RAL, RTV (Month 12) |
|
| ATV, LAM, RAL, RTV (Baseline, Month 12) |
|
| ATV, RAL (Month 12) |
|
| ATV, RAL (Baseline, Month 12) |
|
| ATV, RAL, RTV (Month 12) |
|
| ATV, RAL, RTV (Baseline, Month 12) |
|
| ATV, RTV (Month 12) |
|
| ATV, RTV (Baseline, Month 12) |
|
| DRV, FTC/TDF (Month 12) |
|
| DRV, FTC/TDF (Baseline, Month 12) |
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| DRV, FTC/TDF, ETR (Month 12) |
|
| DRV, FTC/TDF, ETR (Baseline, Month 12) |
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| DRV, FTC/TDF, RTV (Month 12) |
|
| DRV, FTC/TDF, RTV (Baseline, Month 12) |
|
| DRV, ETV, ETR, RTV (Month 12) |
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| DRV, ETV, ETR, RTV (Baseline, Month 12) |
|
| DRV, LAM, RAL (Month 12) |
|
| DRV, LAM, RAL (Baseline, Month 12) |
|
| DRV, LAM, RAL, RTV (Month 12) |
|
| DRV, LAM, RAL, RTV (Baseline, Month 12) |
|
| DRV, LAM, TDF (Month 12) |
|
| DRV, LAM, TDF (Baseline, Month 12) |
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| DRV, NVP, RAL, RTV (Month 12) |
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| DRV, NVP, RAL, RTV (Baseline, Month 12) |
|
| DRV, RAL, RTV (Month 12) |
|
| DRV, RAL, RTV (Baseline, Month 12) |
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| DRV, RTV (Month 12) |
|
| DRV, RTV (Baseline, Month 12) |
|
| DRV, RTV, TZV (Month 12) |
|
| DRV, RTV, TZV (Baseline, Month 12) |
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| FTC/TDF (Month 12) |
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| FTC/TDF (Baseline, Month 12) |
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| FTC/TDF, Kaletra (Month 12) |
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| FTC/TDF, Kaletra (Baseline, Month 12) |
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| FTC/TDF, Kaletra, RAL (Month 12) |
|
| FTC/TDF, Kaletra, RAL (Baseline, Month 12) |
|
| FTC/TDF, Kaletra, SQV (Month 12) |
|
| FTC/TDF, Kaletra, SQV (Baseline, Month 12) |
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| FTC/TDF, RAL (Month 12) |
|
| FTC/TDF, RAL (Baseline, Month 12) |
|
| FTC/TDF, RAL, SQV (Month 12) |
|
| FTC/TDF, RAL, SQV (Baseline, Month 12) |
|
| ETR, RAL, RTV (Month 12) |
|
| ETR, RAL, RTV (Baseline, Month 12) |
|
| Kaletra (Month 12) |
|
| Kaletra (Baseline, Month 12) |
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| LAM, RAL, TDF, ZDV (Month 12) |
|
| LAM, RAL, TDF, ZDV (Baseline, Month 12) |
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| RAL (Month 12) |
|
| RAL (Baseline, Month 12) |
|
| RAL, TDF (Month 12) |
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| RAL, TDF (Baseline, Month 12) |
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| RAL, ZDV W/LAM (Month 12) |
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| RAL, ZDV W/LAM (Baseline, Month 12) |
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| TDF, TZV (Month 12) |
|
| TDF, TZV (Baseline, Month 12) |
|
| TDF, ZDV (Month 12) |
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| TDF, ZDV (Baseline, Month 12) |
|