Trial Outcomes & Findings for Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced NonCCR5-Tropic HIV-1 Infected Subjects (NCT NCT00098748)
NCT ID: NCT00098748
Last Updated: 2010-12-07
Results Overview
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter \[log10 copies/mL\]). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
190 participants
Primary outcome timeframe
Baseline to Week 24 and Week 48
Results posted on
2010-12-07
Participant Flow
Participant milestones
| Measure |
Maraviroc QD
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Assigned to Study Treatment
STARTED
|
63
|
63
|
64
|
|
Assigned to Study Treatment
COMPLETED
|
63
|
61
|
62
|
|
Assigned to Study Treatment
NOT COMPLETED
|
0
|
2
|
2
|
|
Received Study Treatment
STARTED
|
63
|
61
|
62
|
|
Received Study Treatment
Dual-tropic Subjects by Phenotype Assay
|
57
|
52
|
58
|
|
Received Study Treatment
COMPLETED
|
15
|
25
|
18
|
|
Received Study Treatment
NOT COMPLETED
|
48
|
36
|
44
|
|
Continued on Open-Label Treatment
STARTED
|
15
|
25
|
0
|
|
Continued on Open-Label Treatment
COMPLETED
|
7
|
10
|
0
|
|
Continued on Open-Label Treatment
NOT COMPLETED
|
8
|
15
|
0
|
Reasons for withdrawal
| Measure |
Maraviroc QD
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Assigned to Study Treatment
Randomized, but not treated
|
0
|
2
|
2
|
|
Received Study Treatment
Death
|
2
|
1
|
2
|
|
Received Study Treatment
Adverse Event
|
1
|
2
|
5
|
|
Received Study Treatment
Lack of Efficacy
|
40
|
27
|
27
|
|
Received Study Treatment
Other
|
2
|
2
|
6
|
|
Received Study Treatment
Subject defaulted
|
3
|
4
|
4
|
|
Continued on Open-Label Treatment
Adverse Event
|
0
|
1
|
0
|
|
Continued on Open-Label Treatment
Lack of Efficacy
|
1
|
2
|
0
|
|
Continued on Open-Label Treatment
Other reason includes protocol violation
|
6
|
7
|
0
|
|
Continued on Open-Label Treatment
Lost to Follow-up
|
1
|
1
|
0
|
|
Continued on Open-Label Treatment
Withdrawal by Subject
|
0
|
4
|
0
|
Baseline Characteristics
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced NonCCR5-Tropic HIV-1 Infected Subjects
Baseline characteristics by cohort
| Measure |
Maraviroc QD
n=63 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=61 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=62 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<18 years
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Age, Customized
Between 18 and 24 years
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Age, Customized
Between 25 and 34 years
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Age, Customized
Between 35 and 44 years
|
30 participants
n=5 Participants
|
31 participants
n=7 Participants
|
31 participants
n=5 Participants
|
92 participants
n=4 Participants
|
|
Age, Customized
Between 45 and 54 years
|
25 participants
n=5 Participants
|
21 participants
n=7 Participants
|
20 participants
n=5 Participants
|
66 participants
n=4 Participants
|
|
Age, Customized
Between 55 and 64 years
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Age, Customized
≥65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Age Continuous
|
42.7 years
FULL_RANGE 8.4 • n=5 Participants
|
42.5 years
FULL_RANGE 8.0 • n=7 Participants
|
44.6 years
FULL_RANGE 8.3 • n=5 Participants
|
43.3 years
FULL_RANGE 8.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24 and Week 48Population: Full Analysis Set (FAS)-as treated: all randomized subjects classified as dual-tropic by phenotype assay; received at least 1 dose of study treatment. Missing values: discontinuations (DC) imputed as baseline value (change from baseline=0); missing data imputed as Last Observation Carried Forward (LOCF).
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter \[log10 copies/mL\]). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.
Outcome measures
| Measure |
Maraviroc QD
n=57 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=52 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=58 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Change From Baseline in Human Immunodeficiency Virus (HIV-1) Viral Load (Ribonucleic Acid [RNA])
Week 48
|
-0.604 log10 copies/mL
Standard Error 0.1596
|
-1.105 log10 copies/mL
Standard Error 0.2071
|
0.839 log10 copies/mL
Standard Error 0.1851
|
|
Change From Baseline in Human Immunodeficiency Virus (HIV-1) Viral Load (Ribonucleic Acid [RNA])
Week 24
|
-0.890 log10 copies/mL
Standard Error 0.1706
|
-1.194 log10 copies/mL
Standard Error 0.2060
|
-0.953 log10 copies/mL
Standard Error 0.1795
|
SECONDARY outcome
Timeframe: Week 24, Week 48Population: FAS - as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).
Outcome measures
| Measure |
Maraviroc QD
n=57 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=52 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=58 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL
Week 24
|
14 participants
|
16 participants
|
14 participants
|
|
Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL
Week 48
|
13 participants
|
16 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48Population: FAS-as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).
Number of subjects with HIV-1 RNA levels \< 400 copies/mL or at least 0.5 log 10-transformed decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.
Outcome measures
| Measure |
Maraviroc QD
n=57 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=52 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=58 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 0.5 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels
Week 48
|
14 participants
|
22 participants
|
18 participants
|
|
Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 0.5 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels
Week 24
|
24 participants
|
25 participants
|
23 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48Population: FAS-as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).
Number of subjects with HIV-1 RNA levels \< 400 copies/mL or at least 1.0 log 10-transformed decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.
Outcome measures
| Measure |
Maraviroc QD
n=57 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=52 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=58 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 1.0 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels
Week 24
|
18 participants
|
23 participants
|
21 participants
|
|
Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 1.0 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels
Week 48
|
13 participants
|
20 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48Population: FAS - as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).
Outcome measures
| Measure |
Maraviroc QD
n=57 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=52 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=58 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Number of Subjects With HIV-1 RNA Levels < 50 Copies/mL
Week 24
|
12 participants
|
14 participants
|
9 participants
|
|
Number of Subjects With HIV-1 RNA Levels < 50 Copies/mL
Week 48
|
10 participants
|
14 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24 and Week 48Population: FAS - as treated dual-tropic subjects. Placebo N: 4 subjects did not have on-treatment information. Missing data imputed using LOCF.
Change from baseline in CD4 cell count (measured as cells per microliter \[cells/µL\]). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and baseline visits.
Outcome measures
| Measure |
Maraviroc QD
n=57 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=52 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=54 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Change From Baseline in CD4 Cell Count
Week 24
|
59.237 cells/µL
Standard Error 8.9661
|
62.651 cells/µL
Standard Error 10.0234
|
36.367 cells/µL
Standard Error 8.4477
|
|
Change From Baseline in CD4 Cell Count
Week 48
|
65.86 cells/µL
Standard Error 10.822
|
78.87 cells/µL
Standard Error 11.566
|
51.29 cells/µL
Standard Error 12.523
|
SECONDARY outcome
Timeframe: Baseline to Week 24 and Week 48Population: FAS - as treated dual-tropic subjects. Placebo N: 4 subjects did not have on-treatment information. Missing data imputed using LOCF.
Change from baseline in CD8 cell count (measured as cells/µL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and baseline visits.
Outcome measures
| Measure |
Maraviroc QD
n=57 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=52 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=54 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Change From Baseline in CD8 Cell Count
Week 24
|
391.061 cells/µL
Standard Error 57.0135
|
322.683 cells/µL
Standard Error 68.3315
|
154.293 cells/µL
Standard Error 46.8100
|
|
Change From Baseline in CD8 Cell Count
Week 48
|
351.23 cells/µL
Standard Error 54.653
|
342.87 cells/µL
Standard Error 72.222
|
192.30 cells/µL
Standard Error 62.578
|
SECONDARY outcome
Timeframe: Day 1 through Week 24 and through Week 48Population: FAS - as treated dual-tropic subjects; (n)=number of subjects with virologic failure at observation for maraviroc QD, maraviroc BID, and placebo, respectively; Week 48 result values (0.00)=virologic failure at Day 0.
Time to virologic failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of test drug \[perm DC\]; lost to follow-up \[LTFU\]; new anti-retroviral drug added (except background drug change to drug of same class); or on open label for early non-response or rebound). Failure: at Time 0 if level not \<400 copies/mL (2 consecutive visits) before event(s) or last available visit; at time of earliest event if level \<400 copies/mL (on 2 consecutive visits); failure if level ≥400 copies/mL (2 consecutive visits) or 1 visit ≥400 copies/mL followed by perm DC or LTFU.
Outcome measures
| Measure |
Maraviroc QD
n=57 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=52 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=58 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Time (50% Quartile Point Estimate) to Virologic Failure
Week 24 (n=35, 23, 29)
|
88.00 days
Interval 59.0 to
Parameter was not calculable.
|
189.00 days
Interval 113.0 to 189.0
|
100.00 days
Interval 60.0 to
Parameter was not calculable.
|
|
Time (50% Quartile Point Estimate) to Virologic Failure
Week 48 (n=45, 37, 44)
|
0.00 days
Parameters were not calculable.
|
0.00 days
Interval 0.0 to 142.0
|
0.00 days
Interval 0.0 to 29.0
|
SECONDARY outcome
Timeframe: Baseline to Week 24 and Week 48Population: FAS - as treated dual-tropic subjects. Discontinuations prior to time point of analysis imputed as 0.
Change from baseline of TAD in log10 HIV-1 RNA viral load calculated as \[AUC of HIV-1 RNA viral load (log10 copies/mL) / time period\] - Baseline HIV-1 RNA viral load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and baseline visits.
Outcome measures
| Measure |
Maraviroc QD
n=57 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=52 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=58 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Change From Baseline in Time Averaged Difference (TAD) in log10 HIV-1 RNA
Week 24
|
-0.850 log10 copies/mL
Standard Error 0.1510
|
-1.151 log10 copies/mL
Standard Error 0.1895
|
-0.926 log10 copies/mL
Standard Error 0.1679
|
|
Change From Baseline in Time Averaged Difference (TAD) in log10 HIV-1 RNA
Week 48
|
-0.561 log10 copies/mL
Standard Error 0.1475
|
-1.066 log10 copies/mL
Standard Error 0.1962
|
-0.776 log10 copies/mL
Standard Error 0.1700
|
SECONDARY outcome
Timeframe: Baseline through Week 48Population: FAS-as treated dual-tropic subjects. Genotype and phenotype at screening and at time of failure were not summarized as planned.
Number of subjects per genotype and phenotype (tests for presence of non CCR5-tropic HIV-1 and for resistance to reverse transcriptase, protease, and fusion inhibitors) at baseline and at time of failure through Week 48 visit. Sensitivity to drug categorized as 0-1, 2-4, \>4; scores defined as 0=resistance, 1=sensitive or susceptible with higher number indicating greater sensitivity or susceptibility.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening through Week 24Population: FAS-as treated; N=subjects with TX failure due to insufficient clinical response and who had a tropism assessment at Screening. Subjects with DC prior to timepoint not included; LOCF if no result (viral load too low for analysis).
Number of subjects per Tropism status (CCR5 \[R5\], CXCR4 \[X4\], Dual Mixed \[DM\], or Non-reportable/Non-phenotypable \[NR/NP\]) at Screening (Scr) and at time of treatment failure (Tx fail). Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load \<500 copies/ml categorized as below lower limit of quantification (BLQ). Tropism may have been assessed at either the Screening or Baseline visit. The assessment for time of treatment failure is defined as the last on-treatment assessment.
Outcome measures
| Measure |
Maraviroc QD
n=35 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=24 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=24 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Number of Subjects Per Tropism Status at Screening and at the Time of Treatment Failure (Analysis at Week 24)
Scr DM, Tx fail: NR/NP
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Per Tropism Status at Screening and at the Time of Treatment Failure (Analysis at Week 24)
Scr: DM, Tx fail: DM
|
19 participants
|
9 participants
|
16 participants
|
|
Number of Subjects Per Tropism Status at Screening and at the Time of Treatment Failure (Analysis at Week 24)
Scr NR/NP, Tx fail: NR/NP
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Per Tropism Status at Screening and at the Time of Treatment Failure (Analysis at Week 24)
Scr: DM, Tx fail: X4
|
12 participants
|
12 participants
|
2 participants
|
|
Number of Subjects Per Tropism Status at Screening and at the Time of Treatment Failure (Analysis at Week 24)
Scr DM, Tx fail: BLQ
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Per Tropism Status at Screening and at the Time of Treatment Failure (Analysis at Week 24)
Scr: X4, Tx fail: X4
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Subjects Per Tropism Status at Screening and at the Time of Treatment Failure (Analysis at Week 24)
Scr: X4, Tx fail: DM
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Per Tropism Status at Screening and at the Time of Treatment Failure (Analysis at Week 24)
Scr: DM, Tx fail: R5
|
1 participants
|
0 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Screening through Week 48Population: FAS-as treated; N=subjects with TX failure due to insufficient clinical response and who had a tropism assessment at Screening. Subjects with DC prior to timepoint not included; LOCF if no result (viral load too low for analysis).
Number of subjects per Tropism status (CCR5 \[R5\], CXCR4 \[X4\], Dual Mixed \[DM\], or Non-reportable/Non-phenotypable \[NR/NP\]) at Screening (Scr) and at time of treatment failure (Tx fail). Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load \<500 copies/ml categorized as below lower limit of quantification (BLQ). Tropism may have been assessed at either the Screening or Baseline visit. The assessment for time of treatment failure is defined as the last on-treatment assessment.
Outcome measures
| Measure |
Maraviroc QD
n=40 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=27 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=27 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Number of Subjects Per Tropism Status at Screening and Time of Treatment Failure (Analysis at Week 48)
Scr: X4, Tx fail: X4
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Subjects Per Tropism Status at Screening and Time of Treatment Failure (Analysis at Week 48)
Scr: X4, Tx fail: DM
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Per Tropism Status at Screening and Time of Treatment Failure (Analysis at Week 48)
Scr: DM, Tx fail: R5
|
1 participants
|
1 participants
|
5 participants
|
|
Number of Subjects Per Tropism Status at Screening and Time of Treatment Failure (Analysis at Week 48)
Scr: DM, Tx fail: X4
|
12 participants
|
12 participants
|
2 participants
|
|
Number of Subjects Per Tropism Status at Screening and Time of Treatment Failure (Analysis at Week 48)
Scr: DM, Tx fail: DM
|
24 participants
|
10 participants
|
18 participants
|
|
Number of Subjects Per Tropism Status at Screening and Time of Treatment Failure (Analysis at Week 48)
Scr: DM, Tx fail: NR/NP
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Subjects Per Tropism Status at Screening and Time of Treatment Failure (Analysis at Week 48)
Scr: DM, Tx fail: BLQ
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Per Tropism Status at Screening and Time of Treatment Failure (Analysis at Week 48)
Scr: NR/NP, Tx fail: NR/NP
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Screening, Week 24Population: FAS - as treated dual-tropic subjects. Missing values imputed as LOCF.
Number of subjects for association between screening resistance and virologic response as determined by treatment failure and OSS at screening. OSS categorized as 0-1, 2-4, \>4 (maximum value of 6) and calculated as the sum of the net assessment of in vitro phenotypic and genotypic susceptibility using a binary scoring system (0= reduced susceptibility, 1=susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.
Outcome measures
| Measure |
Maraviroc QD
n=57 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=52 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=58 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Number of Subjects With Treatment Failure at Week 24 by Overall Susceptibility Score (OSS) at Screening
Scr score: 0-1
|
21 participants
|
12 participants
|
17 participants
|
|
Number of Subjects With Treatment Failure at Week 24 by Overall Susceptibility Score (OSS) at Screening
Scr score: 2-4
|
35 participants
|
35 participants
|
40 participants
|
|
Number of Subjects With Treatment Failure at Week 24 by Overall Susceptibility Score (OSS) at Screening
Scr score: missing
|
1 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Screening, Week48Population: FAS - as treated dual-tropic subjects. Missing values imputed as LOCF.
Number of subjects for association between screening resistance and virologic response as determined by treatment failure and OSS at screening. OSS categorized as 0, 1, 2, or ≥3 (maximum value of 6) and calculated as the sum of the net assessment of in vitro phenotypic and genotypic susceptibility using a binary scoring system (0= reduced susceptibility, 1=susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.
Outcome measures
| Measure |
Maraviroc QD
n=57 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=52 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=58 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Number of Subjects With Treatment Failure at Week 48 by Overall Susceptibility Score (OSS) at Screening
Scr score: 0
|
1 particpants
|
2 particpants
|
2 particpants
|
|
Number of Subjects With Treatment Failure at Week 48 by Overall Susceptibility Score (OSS) at Screening
Scr score: 1
|
19 particpants
|
11 particpants
|
15 particpants
|
|
Number of Subjects With Treatment Failure at Week 48 by Overall Susceptibility Score (OSS) at Screening
Scr score: 2
|
21 particpants
|
14 particpants
|
13 particpants
|
|
Number of Subjects With Treatment Failure at Week 48 by Overall Susceptibility Score (OSS) at Screening
Scr score: ≥3
|
15 particpants
|
24 particpants
|
27 particpants
|
|
Number of Subjects With Treatment Failure at Week 48 by Overall Susceptibility Score (OSS) at Screening
Scr score: missing
|
1 particpants
|
1 particpants
|
1 particpants
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: FAS - as randomized; N=number of subjects with Category C Adverse Events for maraviroc QD, maraviroc BID, and placebo, respectively. Week 48 results reflect subsequent updates to data originally reported at Week 24.
Number of subjects with AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C Adverse Events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 7 days after last dose of study drug.
Outcome measures
| Measure |
Maraviroc QD
n=63 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=61 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=62 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 24)
Pneumonia
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 24)
Candidiasis
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 24)
Cytomegalovirus chorioretinitis
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 24)
Herpes simplex
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 24)
Histoplasmosis
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 24)
Mycobacterium avium complex infection
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 24)
Oesophageal candidiasis
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 24)
Encephalitis
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 24)
Pneumocystis jiroveci pneumonia
|
3 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 48Population: FAS - as randomized; N=number of subjects with Category C Adverse Events for maraviroc QD, maraviroc BID, and placebo, respectively. Week 48 results reflect subsequent updates to data originally reported at Week 24.
Number of subjects with AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C Adverse Events per CDC HIV Classification System. Includes events occurring up to 7 days after last dose of study drug.
Outcome measures
| Measure |
Maraviroc QD
n=63 Participants
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=61 Participants
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=62 Participants
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 48)
Candidiasis
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 48)
Cytomegalovirus chorioretinitis
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 48)
Histoplasmosis
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 48)
Oesophageal candidiasis
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 48)
Pneumococcal Sepsis
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 48)
Pneumocystis jiroveci pneumonia
|
3 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 48)
Pneumonia
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 48)
Encephalitis
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Maraviroc QD
Serious events: 13 serious events
Other events: 46 other events
Deaths: 0 deaths
Maraviroc BID
Serious events: 14 serious events
Other events: 51 other events
Deaths: 0 deaths
Placebo
Serious events: 13 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Maraviroc QD
n=63 participants at risk
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=62 participants at risk
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=61 participants at risk
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/63
|
1.6%
1/62
|
0.00%
0/61
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.6%
1/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/63
|
1.6%
1/62
|
0.00%
0/61
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/63
|
1.6%
1/62
|
1.6%
1/61
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
General disorders
Asthenia
|
0.00%
0/63
|
1.6%
1/62
|
1.6%
1/61
|
|
General disorders
Condition aggravated
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
General disorders
Disease progression
|
0.00%
0/63
|
1.6%
1/62
|
0.00%
0/61
|
|
General disorders
Fatigue
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
General disorders
Pyrexia
|
4.8%
3/63
|
1.6%
1/62
|
0.00%
0/61
|
|
Hepatobiliary disorders
Hepatitis
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/63
|
1.6%
1/62
|
1.6%
1/61
|
|
Infections and infestations
Abscess
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Infections and infestations
Candidiasis
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/63
|
3.2%
2/62
|
0.00%
0/61
|
|
Infections and infestations
Ear infection
|
0.00%
0/63
|
1.6%
1/62
|
0.00%
0/61
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/63
|
1.6%
1/62
|
0.00%
0/61
|
|
Infections and infestations
Histoplasmosis
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Infections and infestations
Meningitis aseptic
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/63
|
3.2%
2/62
|
0.00%
0/61
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/63
|
1.6%
1/62
|
0.00%
0/61
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
4.8%
3/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Infections and infestations
Pneumonia
|
4.8%
3/63
|
3.2%
2/62
|
1.6%
1/61
|
|
Infections and infestations
Pneumonia bacterial
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/63
|
1.6%
1/62
|
0.00%
0/61
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/63
|
1.6%
1/62
|
1.6%
1/61
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/63
|
1.6%
1/62
|
0.00%
0/61
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/63
|
1.6%
1/62
|
1.6%
1/61
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/63
|
1.6%
1/62
|
0.00%
0/61
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Nervous system disorders
Encephalitis
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Nervous system disorders
Movement disorder
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Psychiatric disorders
Depression
|
0.00%
0/63
|
0.00%
0/62
|
3.3%
2/61
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
1/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/63
|
1.6%
1/62
|
0.00%
0/61
|
Other adverse events
| Measure |
Maraviroc QD
n=63 participants at risk
Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
|
Maraviroc BID
n=62 participants at risk
Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
|
Placebo
n=61 participants at risk
Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.3%
4/63
|
0.00%
0/62
|
1.6%
1/61
|
|
Gastrointestinal disorders
Constipation
|
9.5%
6/63
|
8.1%
5/62
|
1.6%
1/61
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
18/63
|
19.4%
12/62
|
21.3%
13/61
|
|
Gastrointestinal disorders
Nausea
|
14.3%
9/63
|
12.9%
8/62
|
19.7%
12/61
|
|
Gastrointestinal disorders
Vomiting
|
12.7%
8/63
|
4.8%
3/62
|
13.1%
8/61
|
|
General disorders
Asthenia
|
0.00%
0/63
|
3.2%
2/62
|
11.5%
7/61
|
|
General disorders
Fatigue
|
12.7%
8/63
|
16.1%
10/62
|
18.0%
11/61
|
|
General disorders
Injection site reaction
|
11.1%
7/63
|
21.0%
13/62
|
14.8%
9/61
|
|
General disorders
Pyrexia
|
7.9%
5/63
|
9.7%
6/62
|
6.6%
4/61
|
|
Infections and infestations
Bronchitis
|
6.3%
4/63
|
9.7%
6/62
|
3.3%
2/61
|
|
Infections and infestations
Herpes simplex
|
6.3%
4/63
|
6.5%
4/62
|
3.3%
2/61
|
|
Infections and infestations
Influenza
|
1.6%
1/63
|
6.5%
4/62
|
1.6%
1/61
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
5/63
|
4.8%
3/62
|
4.9%
3/61
|
|
Infections and infestations
Oral candidiasis
|
1.6%
1/63
|
8.1%
5/62
|
0.00%
0/61
|
|
Infections and infestations
Pharyngitis
|
1.6%
1/63
|
8.1%
5/62
|
0.00%
0/61
|
|
Infections and infestations
Sinusitis
|
4.8%
3/63
|
9.7%
6/62
|
6.6%
4/61
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
5/63
|
16.1%
10/62
|
8.2%
5/61
|
|
Investigations
Weight increased
|
6.3%
4/63
|
0.00%
0/62
|
0.00%
0/61
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
3/63
|
6.5%
4/62
|
1.6%
1/61
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
5/63
|
12.9%
8/62
|
3.3%
2/61
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/63
|
9.7%
6/62
|
3.3%
2/61
|
|
Nervous system disorders
Dizziness
|
9.5%
6/63
|
9.7%
6/62
|
4.9%
3/61
|
|
Nervous system disorders
Headache
|
20.6%
13/63
|
17.7%
11/62
|
8.2%
5/61
|
|
Psychiatric disorders
Insomnia
|
7.9%
5/63
|
8.1%
5/62
|
4.9%
3/61
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
7/63
|
9.7%
6/62
|
6.6%
4/61
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
3/63
|
6.5%
4/62
|
1.6%
1/61
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/63
|
6.5%
4/62
|
0.00%
0/61
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.3%
4/63
|
4.8%
3/62
|
1.6%
1/61
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
2/63
|
4.8%
3/62
|
8.2%
5/61
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
7/63
|
9.7%
6/62
|
11.5%
7/61
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER