HIV-1
Conditions
Keywords
HIV-1, non-interventional, CCR-5 tropic virus, therapy experienced patients
Brief 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®.
Detailed description
Non interventional study, inclusion and exclusion criteria defined by the labelling of Celsentri (Maraviroc).
Interventions
DRUGmaraviroc
No intervention; any procedure at the discretion of the treating physician, in line with the SmPC
Sponsors
Pfizer
ViiV Healthcare
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
HIV-1 infection. CCR-5 tropic virus. Therapy experienced patient,
Exclusion criteria
X4 or D/M tropic virus. Therapy-naive patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12 | Month 12 | Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C). |
| 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 | — |
| Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3 | 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 | Month 6 | Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C). |
| 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 | — |
| Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3 | Baseline, Month 3 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Human Immunodeficiency Virus (HIV) Response | Month 12 | Response was defined as a HIV-1 RNA count of less than 50 copies/mL. |
| Physician's Assessment of Efficacy | Month 12 | 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 | Baseline, Month 12 | 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). |
| Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12 | Baseline, Months 6, 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 79 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Insufficient clinical response | 3 |
| Overall Study | Other | 5 |
Baseline characteristics
| Characteristic | Maraviroc |
|---|---|
| Acquired Immune Deficiency Syndrome Clinical Trials Group Symptom Distress Module(SDM) Overall Score | 17.37 units on a scale STANDARD_DEVIATION 14.026 |
| Age Continuous | 44.1 years STANDARD_DEVIATION 11.2 |
| Cluster of Differentiation 4 (CD4+) Cell Counts | 458.8 cells/microliter (cells/mcL) STANDARD_DEVIATION 250.14 |
| Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) | 3.01 copies/milliliter (copies/mL) STANDARD_DEVIATION 1.599 |
| Number of Participants With Centers for Disease Control and Prevention (CDC) Classification Category A | 31 participants |
| Number of Participants With Centers for Disease Control and Prevention (CDC) Classification Category B | 21 participants |
| Number of Participants With Centers for Disease Control and Prevention (CDC) Classification Category C | 27 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 79 |
| serious Total, serious adverse events | 3 / 79 |
Outcome results
Primary
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12
Time frame: Baseline, Month 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maraviroc | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12 | 97.57 cells/mcL | Standard Deviation 237.7 |
Primary
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3
Time frame: Baseline, Month 3
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maraviroc | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3 | 74.31 cells/mcL | Standard Deviation 162.18 |
Primary
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6
Time frame: Baseline, Month 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maraviroc | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6 | 91.88 cells/mcL | Standard Deviation 168.43 |
Primary
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12
Time frame: Baseline, Month 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maraviroc | Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12 | -0.95 copies/mL | Standard Deviation 1.571 |
Primary
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3
Time frame: Baseline, Month 3
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maraviroc | Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3 | -1.10 copies/mL | Standard Deviation 1.53 |
Primary
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6
Time frame: Baseline, Month 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maraviroc | Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6 | -1.15 copies/mL | Standard Deviation 1.579 |
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).
Time frame: Month 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc | Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12 | Category C | 28 participants |
| Maraviroc | Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12 | Category A | 31 participants |
| Maraviroc | Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12 | Category B | 20 participants |
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).
Time frame: Month 3
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc | Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3 | Category A | 31 participants |
| Maraviroc | Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3 | Category B | 19 participants |
| Maraviroc | Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3 | Category C | 26 participants |
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).
Time frame: Month 6
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc | Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6 | Category A | 31 participants |
| Maraviroc | Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6 | Category B | 16 participants |
| Maraviroc | Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6 | Category C | 27 participants |
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.
Time frame: Baseline, Months 6, 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maraviroc | Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12 | Change at Month 6 (n=51) | -4.87 units on a scale | Standard Deviation 12.527 |
| Maraviroc | Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12 | Change at Month 12 (n=79) | -2.14 units on a scale | Standard Deviation 11.728 |
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).
Time frame: Baseline, Month 12
Population: FAS population included all participants who received at least one dose (including partial doses) of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, LAM, RAL (Baseline, Month 12) | 0 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ABC/LAM, RAL, TDF (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ABC/LAM, RAL, TDF (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ATV (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ATV (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ATV, FTC/TDF (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, LAM, RAL, RTV (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ATV, FTC/TDF (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ATV, FTC/TDF, RTV (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ATV, FTC/TDF, RTV (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ATV, LAM, RAL, RTV (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ATV, LAM, RAL, RTV (Baseline, Month 12) | 0 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ATV, RAL (Month 12) | 2 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ATV, RAL (Baseline, Month 12) | 2 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ATV, RAL, RTV (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ATV, RAL, RTV (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ATV, RTV (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ATV, RTV (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, FTC/TDF (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, FTC/TDF (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, FTC/TDF, ETR (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, FTC/TDF, ETR (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, FTC/TDF, RTV (Month 12) | 6 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, FTC/TDF, RTV (Baseline, Month 12) | 5 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, ETV, ETR, RTV (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, ETV, ETR, RTV (Baseline, Month 12) | 0 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, LAM, RAL (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, LAM, RAL, RTV (Baseline, Month 12) | 0 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, LAM, TDF (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, LAM, TDF (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, NVP, RAL, RTV (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, NVP, RAL, RTV (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, RAL, RTV (Month 12) | 4 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, RAL, RTV (Baseline, Month 12) | 4 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, RTV (Month 12) | 2 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, RTV (Baseline, Month 12) | 2 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, RTV, TZV (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | DRV, RTV, TZV (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | FTC/TDF (Month 12) | 13 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | FTC/TDF (Baseline, Month 12) | 11 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | FTC/TDF, Kaletra (Month 12) | 2 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | RAL, TDF (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | FTC/TDF, Kaletra (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | FTC/TDF, Kaletra, RAL (Month 12) | 3 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | FTC/TDF, Kaletra, RAL (Baseline, Month 12) | 3 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | FTC/TDF, Kaletra, SQV (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | FTC/TDF, Kaletra, SQV (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | FTC/TDF, RAL (Month 12) | 5 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | FTC/TDF, RAL (Baseline, Month 12) | 4 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | FTC/TDF, RAL, SQV (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | FTC/TDF, RAL, SQV (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ETR, RAL, RTV (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ETR, RAL, RTV (Baseline, Month 12) | 0 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | Kaletra (Month 12) | 2 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | Kaletra (Baseline, Month 12) | 2 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | LAM, RAL, TDF, ZDV (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | LAM, RAL, TDF, ZDV (Baseline, Month 12) | 0 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | RAL (Month 12) | 2 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | RAL (Baseline, Month 12) | 2 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | RAL, TDF (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | RAL, ZDV W/LAM (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | RAL, ZDV W/LAM (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | TDF, TZV (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | TDF, TZV (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | TDF, ZDV (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | TDF, ZDV (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ABC, FTC/TDF (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ABC, FTC/TDF (Baseline, Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ABC/LAM (Month 12) | 2 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ABC/LAM (Baseline, Month 12) | 2 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ABC/LAM, DRV, RAL (Month 12) | 1 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ABC/LAM, DRV, RAL (Baseline, Month 12) | 0 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ABC/LAM, RAL (Month 12) | 2 participants |
| Maraviroc | Number of Participants Taking Concomitant Therapy | ABC/LAM, RAL (Baseline, Month 12) | 2 participants |
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.
Time frame: Month 12
Population: FAS population included all participants who received at least one dose (including partial doses) of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maraviroc | Number of Participants With Human Immunodeficiency Virus (HIV) Response | 51 participants |
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.
Time frame: Month 12
Population: FAS population included all participants who received at least one dose (including partial doses) of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maraviroc | Physician's Assessment of Efficacy | Excellent | 15 participants |
| Maraviroc | Physician's Assessment of Efficacy | Very Good | 42 participants |
| Maraviroc | Physician's Assessment of Efficacy | Good | 14 participants |
| Maraviroc | Physician's Assessment of Efficacy | Fair | 1 participants |
| Maraviroc | Physician's Assessment of Efficacy | Poor | 1 participants |