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A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients

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ClinicalTrials.gov Identifier: NCT00827112
Recruitment Status : Completed
First Posted : January 22, 2009
Results First Posted : November 24, 2011
Last Update Posted : June 15, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Human Immunodeficiency Virus-1
Intervention Drug: maraviroc
Enrollment 129

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Hide Arm/Group Description Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks. Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
Period Title: Overall Study
Started 65 64
Treated 60 61
Completed 50 52
Not Completed 15 12
Reason Not Completed
Adverse Event             2             0
Lack of Efficacy             2             0
Lost to Follow-up             3             2
Pregnancy             0             1
Protocol Violation             0             2
Withdrawal by Subject             2             1
Randomized but not treated             5             3
Other             1             3
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine / Tenofovir Total
Hide Arm/Group Description Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks. Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks. Total of all reporting groups
Overall Number of Baseline Participants 60 61 121
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 61 participants 121 participants
38.3  (10.2) 35.3  (10.5) 36.8  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 61 participants 121 participants
Female
4
   6.7%
9
  14.8%
13
  10.7%
Male
56
  93.3%
52
  85.2%
108
  89.3%
1.Primary Outcome
Title Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)
Hide Description [Not Specified]
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement.
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 59 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
74.60
(63.47 to 85.69)
83.60
(74.32 to 92.90)
2.Secondary Outcome
Title HIV-1 RNA Levels at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement.
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 59 61
Mean (Standard Deviation)
Unit of Measure: copies/mL
84982  (127008) 114827  (149638)
3.Secondary Outcome
Title Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
Hide Description Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only.
Time Frame Baseline , Days 4, 7, 10 and 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
First 15 participants who were enrolled at U.S sites and had taken the study drug .
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: copies/mL
Change at Day 4 1800.00  (37351.09) -46479.40  (62259.15)
Change at Day 7 -36947.90  (28463.80) -52137.10  (68684.14)
Change at Day 10 -58595.80  (66157.66) -54925.90  (70846.93)
Change at Day 14 -47271.60  (38234.34) -55449.90  (71207.16)
4.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Maraviroc
Hide Description [Not Specified]
Time Frame Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis population included first 15 participants treated with maraviroc.
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: nanogram (ng)/mL
650
(178 to 1490)
5.Secondary Outcome
Title Minimum Observed Plasma Concentration (Cmin) of Maraviroc
Hide Description [Not Specified]
Time Frame Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included first 15 participants treated with maraviroc.
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: ng/mL
37.0
(8.4 to 92.7)
6.Secondary Outcome
Title Average Observed Plasma Concentration (Cavg) of Maraviroc
Hide Description Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24).
Time Frame Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included first 15 participants treated with maraviroc.
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
185.10  (71.08)
7.Secondary Outcome
Title Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96
Hide Description [Not Specified]
Time Frame Baseline, Week 16, Week 24, Week 48, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 59 61
Mean (Standard Deviation)
Unit of Measure: log10 copies/ml
Baseline (n= 59, 61) 84982  (127008) 114827  (149638)
Change at Week 16 (n= 54, 58) -89859.1  (131317.35) -107684.6  (149476.47)
Change at Week 24 (n= 56, 58) -87241.2  (129638.57) -110498.1  (149836.29)
Change at Week 48 (n= 53, 54) -82343.4  (119356.62) -115582.9  (153705.26)
Change at Week 96 (n= 49, 51) -80117.7  (121443.50) -99662.6  (116525.87)
8.Secondary Outcome
Title Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Hide Description [Not Specified]
Time Frame Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 59 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 (n= 55, 60)
0
(0 to 0)
6.60
(0.35 to 12.77)
Week 4 (n= 57, 60)
8.50
(1.37 to 15.58)
21.30
(11.03 to 31.59)
Week 8 (n= 57, 59)
47.50
(34.72 to 60.20)
42.60
(30.21 to 55.03)
Week 12 (n= 55, 59)
61.00
(48.57 to 73.46)
62.30
(50.13 to 74.46)
Week 16 (n= 54, 58)
72.90
(61.54 to 84.23)
73.80
(62.73 to 84.81)
Week 20 (n= 56, 57)
71.20
(59.63 to 82.74)
83.61
(74.32 to 92.90)
Week 24 (n= 56, 58)
81.36
(71.42 to 91.29)
88.52
(80.53 to 96.52)
Week 32 (n= 55, 57)
79.66
(69.39 to 89.93)
88.52
(80.53 to 96.52)
Week 40 (n= 54, 55)
81.36
(71.42 to 91.29)
88.52
(80.53 to 96.52)
Week 48 (n= 53, 54)
74.58
(63.47 to 85.69)
83.61
(74.32 to 92.90)
Week 60 (n= 52, 53)
67.80
(55.87 to 79.72)
85.25
(76.35 to 94.15)
Week 72 (n= 52, 53)
74.58
(63.47 to 85.69)
81.97
(72.32 to 91.62)
Week 84 (n= 50, 52)
76.27
(65.42 to 87.13)
83.61
(74.32 to 92.90)
Week 96 (n= 49, 51)
67.80
(55.87 to 79.72)
81.97
(72.32 to 91.62)
9.Secondary Outcome
Title Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Hide Description [Not Specified]
Time Frame Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 59 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 (n= 55, 60)
27.12
(15.77 to 38.46)
34.43
(22.50 to 46.35)
Week 4 (n= 57, 60)
50.85
(38.09 to 63.60)
52.46
(39.93 to 64.99)
Week 8 (n= 57, 59)
79.66
(69.39 to 89.93)
77.05
(66.50 to 87.60)
Week 12 (n= 55, 59)
89.83
(82.12 to 97.54)
88.52
(80.53 to 96.52)
Week 16 (n= 54, 58)
88.14
(79.88 to 96.39)
91.80
(84.92 to 98.69)
Week 20 (n= 56, 57)
89.83
(82.12 to 97.54)
93.44
(87.23 to 99.65)
Week 24 (n= 56, 58)
91.53
(84.42 to 98.63)
93.44
(87.23 to 99.65)
Week 32 (n= 55, 57)
89.83
(82.12 to 97.54)
93.44
(87.23 to 99.65)
Week 40 (n= 54, 55)
91.53
(84.42 to 98.63)
90.16
(82.69 to 97.64)
Week 48 (n= 53, 54)
89.83
(82.12 to 97.54)
86.89
(78.41 to 95.36)
Week 60 (n= 52, 53)
86.44
(77.70 to 95.18)
86.89
(78.41 to 95.36)
Week 72 (n= 52, 53)
86.44
(77.70 to 95.18)
85.25
(76.35 to 94.15)
Week 84 (n= 50, 52)
81.36
(71.42 to 91.29)
85.25
(76.35 to 94.15)
Week 96 (n= 49, 51)
77.97
(67.39 to 88.54)
83.61
(74.32 to 92.90)
10.Secondary Outcome
Title Time to Loss of Virological Response (TLOVR)
Hide Description TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm.
Time Frame Baseline through Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 59 61
Mean (Standard Error)
Unit of Measure: Days
436.2  (22.5) 463.8  (16.1)
11.Secondary Outcome
Title Time-Averaged Difference (TAD) in log10 Viral Load
Hide Description TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL).
Time Frame Week 16, Week 24, Week 48, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here N (Number of participants analyzed) signified participants evaluable for the measure.
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 51 52
Mean (Standard Error)
Unit of Measure: log10 copies/mL
Week 16 -2.459  (0.046) -2.402  (0.045)
Week 24 -2.663  (0.048) -2.626  (0.046)
Week 48 -2.897  (0.046) -2.868  (0.050)
Week 96 -2.998  (0.055) -3.001  (0.053)
12.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96
Hide Description [Not Specified]
Time Frame Baseline, Week 16, Week 24, Week 48, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 59 61
Mean (Standard Deviation)
Unit of Measure: cells/microliter (cells/mcL)
Baseline (n= 59, 61) 357.70  (123.53) 390.00  (152.34)
Change at Week 16 (n= 54, 58) 169.60  (117.20) 139.80  (102.62)
Change at Week 24 (n= 54, 57) 188.90  (125.14) 173.30  (130.55)
Change at Week 48 (n= 52, 53) 215.70  (166.59) 226.60  (138.04)
Change at Week 96 (n= 50, 51) 287.50  (173.23) 298.50  (160.54)
13.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96
Hide Description [Not Specified]
Time Frame Baseline, Week 16, Week 24, Week 48, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 59 61
Mean (Standard Deviation)
Unit of Measure: cells/mcL
Baseline (n= 59, 61) 931.10  (446.26) 1125.60  (735.08)
Change at Week 16 (n= 54, 58) 63.70  (290.49) -153.80  (473.96)
Change at Week 24 (n= 54, 57) 6.20  (334.89) -178.00  (508.75)
Change at Week 48 (n= 52, 53) -76.80  (354.48) -267.60  (574.22)
Change at Week 96 (n= 50, 51) -63.00  (355.60) -231.40  (516.99)
14.Secondary Outcome
Title Number of Participants With Genotypic Resistance
Hide Description Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.
Time Frame Week 96 or Time of treatment failure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 59 61
Measure Type: Number
Unit of Measure: Participants
0 0
15.Secondary Outcome
Title Number of Participants With Phenotypic Resistance
Hide Description Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.
Time Frame Week 96 or Time of treatment failure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 59 61
Measure Type: Number
Unit of Measure: Participants
0 0
16.Secondary Outcome
Title Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay
Hide Description Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} [X4]-using HIV-1 RNA represented 0.3 percent of the total viral population.
Time Frame Baseline to Week 96 or Time of treatment Failure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Hide Arm/Group Description:
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
Overall Number of Participants Analyzed 60 61
Measure Type: Number
Unit of Measure: Participants
Baseline 60 61
Week 96 or Time of treatment Failure 0 0
Time Frame Baseline to follow-up period (28 days after the last dose of study)
Adverse Event Reporting Description 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.
 
Arm/Group Title Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine/ Tenofovir
Hide Arm/Group Description Maraviroc 150 milligram (mg) tablets once daily along with atazanavir 300 mg or ritonavir 100 mg tablets once daily were orally administered for 96 weeks. Atazanavir/ritonavir 300 mg/100 mg tablets QD along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
All-Cause Mortality
Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine/ Tenofovir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine/ Tenofovir
Affected / at Risk (%) Affected / at Risk (%)
Total   13/60 (21.67%)   11/61 (18.03%) 
Congenital, familial and genetic disorders     
Bronchogenic cyst * 1  1/60 (1.67%)  0/61 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/60 (0.00%)  1/61 (1.64%) 
Enterocolitis * 1  0/60 (0.00%)  1/61 (1.64%) 
Intestinal perforation * 1  1/60 (1.67%)  0/61 (0.00%) 
Oesophageal stenosis * 1  0/60 (0.00%)  1/61 (1.64%) 
Vomiting * 1  0/60 (0.00%)  1/61 (1.64%) 
Parotitis * 1  0/60 (0.00%)  1/61 (1.64%) 
Hepatobiliary disorders     
Bile duct stone * 1  1/60 (1.67%)  0/61 (0.00%) 
Cholelithiasis * 1  1/60 (1.67%)  0/61 (0.00%) 
Infections and infestations     
Anogenital warts * 1  1/60 (1.67%)  1/61 (1.64%) 
Bacteraemia * 1  0/60 (0.00%)  1/61 (1.64%) 
Cellulitis * 1  1/60 (1.67%)  0/61 (0.00%) 
Gastroenteritis viral * 1  1/60 (1.67%)  0/61 (0.00%) 
Pneumonia * 1  0/60 (0.00%)  1/61 (1.64%) 
Pyelonephritis * 1  0/60 (0.00%)  1/61 (1.64%) 
Sepsis * 1  0/60 (0.00%)  1/61 (1.64%) 
Sepsis syndrome * 1  0/60 (0.00%)  1/61 (1.64%) 
Meningitis viral * 1  1/60 (1.67%)  0/61 (0.00%) 
Injury, poisoning and procedural complications     
Concussion * 1  0/60 (0.00%)  1/61 (1.64%) 
Foot fracture * 1  0/60 (0.00%)  1/61 (1.64%) 
Tendon rupture * 1  1/60 (1.67%)  0/61 (0.00%) 
Hand fracture * 1  0/60 (0.00%)  1/61 (1.64%) 
Musculoskeletal and connective tissue disorders     
Costochondritis * 1  1/60 (1.67%)  0/61 (0.00%) 
Nervous system disorders     
Cognitive disorder * 1  1/60 (1.67%)  0/61 (0.00%) 
Epilepsy * 1  0/60 (0.00%)  1/61 (1.64%) 
Reversible ischaemic neurological deficit * 1  0/60 (0.00%)  1/61 (1.64%) 
Psychiatric disorders     
Mental status changes * 1  0/60 (0.00%)  1/61 (1.64%) 
Psychotic disorder * 1  1/60 (1.67%)  0/61 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis * 1  1/60 (1.67%)  0/61 (0.00%) 
Renal colic * 1  0/60 (0.00%)  1/61 (1.64%) 
Renal failure * 1  0/60 (0.00%)  1/61 (1.64%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  2/60 (3.33%)  0/61 (0.00%) 
Hypoxia * 1  1/60 (1.67%)  0/61 (0.00%) 
Pulmonary sarcoidosis * 1  1/60 (1.67%)  0/61 (0.00%) 
Vascular disorders     
Intra-abdominal haemorrhage * 1  0/60 (0.00%)  1/61 (1.64%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MeDRA v14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Maraviroc+ Atazanavir / Ritonavir Atazanavir / Ritonavir + Emtricitabine/ Tenofovir
Affected / at Risk (%) Affected / at Risk (%)
Total   55/60 (91.67%)   58/61 (95.08%) 
Eye disorders     
Ocular icterus * 1  13/60 (21.67%)  7/61 (11.48%) 
Conjunctivitis * 1  1/60 (1.67%)  5/61 (8.20%) 
Gastrointestinal disorders     
Abdominal pain upper * 1  3/60 (5.00%)  0/61 (0.00%) 
Constipation * 1  4/60 (6.67%)  1/61 (1.64%) 
Diarrhoea * 1  15/60 (25.00%)  14/61 (22.95%) 
Haemorrhoids * 1  4/60 (6.67%)  3/61 (4.92%) 
Nausea * 1  6/60 (10.00%)  16/61 (26.23%) 
Vomiting * 1  8/60 (13.33%)  6/61 (9.84%) 
General disorders     
Fatigue * 1  3/60 (5.00%)  7/61 (11.48%) 
Pyrexia * 1  4/60 (6.67%)  3/61 (4.92%) 
Hepatobiliary disorders     
Hyperbilirubinaemia * 1  18/60 (30.00%)  16/61 (26.23%) 
Jaundice * 1  10/60 (16.67%)  6/61 (9.84%) 
Infections and infestations     
Anogenital warts * 1  4/60 (6.67%)  4/61 (6.56%) 
Bronchitis * 1  8/60 (13.33%)  5/61 (8.20%) 
Gonorrhoea * 1  4/60 (6.67%)  2/61 (3.28%) 
Herpes zoster * 1  3/60 (5.00%)  6/61 (9.84%) 
Influenza * 1  4/60 (6.67%)  6/61 (9.84%) 
Nasopharyngitis * 1  3/60 (5.00%)  6/61 (9.84%) 
Sinusitis * 1  10/60 (16.67%)  3/61 (4.92%) 
Tonsillitis * 1  4/60 (6.67%)  0/61 (0.00%) 
Upper respiratory tract infection * 1  8/60 (13.33%)  8/61 (13.11%) 
Pharyngitis * 1  3/60 (5.00%)  3/61 (4.92%) 
Syphilis * 1  3/60 (5.00%)  1/61 (1.64%) 
Urinary tract infection * 1  3/60 (5.00%)  2/61 (3.28%) 
Investigations     
Aspartate aminotransferase increased * 1  4/60 (6.67%)  1/61 (1.64%) 
Blood amylase increased * 1  4/60 (6.67%)  2/61 (3.28%) 
Blood bilirubin increased * 1  7/60 (11.67%)  5/61 (8.20%) 
Blood creatine phosphokinase increased * 1  6/60 (10.00%)  0/61 (0.00%) 
Blood creatinine increased * 1  3/60 (5.00%)  1/61 (1.64%) 
Blood uric acid increased * 1  4/60 (6.67%)  0/61 (0.00%) 
Alanine aminotransferase increased * 1  3/60 (5.00%)  2/61 (3.28%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  3/60 (5.00%)  3/61 (4.92%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity * 1  1/60 (1.67%)  4/61 (6.56%) 
Nervous system disorders     
Headache * 1  6/60 (10.00%)  9/61 (14.75%) 
Psychiatric disorders     
Depression * 1  7/60 (11.67%)  8/61 (13.11%) 
Insomnia * 1  5/60 (8.33%)  4/61 (6.56%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  4/60 (6.67%)  6/61 (9.84%) 
Rhinitis allergic * 1  2/60 (3.33%)  4/61 (6.56%) 
Skin and subcutaneous tissue disorders     
Rash * 1  5/60 (8.33%)  4/61 (6.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MeDRA v14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00827112     History of Changes
Other Study ID Numbers: A4001078
First Submitted: January 21, 2009
First Posted: January 22, 2009
Results First Submitted: July 11, 2011
Results First Posted: November 24, 2011
Last Update Posted: June 15, 2012