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Multicenter, Safety Study Of Maraviroc

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ClinicalTrials.gov Identifier: NCT00478231
Recruitment Status : Completed
First Posted : May 24, 2007
Results First Posted : August 8, 2011
Last Update Posted : September 9, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acquired Immunodeficiency Syndrome
HIV Infection
Intervention Drug: Maraviroc
Enrollment 209

Recruitment Details  
Pre-assignment Details A total of 638 participants were screened, out of which 429 participants were screen failures and 209 were assigned to the study treatment.
Arm/Group Title Maraviroc
Hide Arm/Group Description Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Period Title: Overall Study
Started 209
Treated 206
Completed 125
Not Completed 84
Reason Not Completed
Death             7
Lack of Efficacy             47
Lost to Follow-up             7
Withdrawal by Subject             6
Other             9
Adverse Event             5
Randomized, not treated             3
Arm/Group Title Maraviroc
Hide Arm/Group Description Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Baseline Participants 206
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 206 participants
43.2  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants
Female
61
  29.6%
Male
145
  70.4%
1.Primary Outcome
Title Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description AEs: any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was congenital anomaly. Grade 3: Events that interrupted participant’s usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4: Events which were unacceptable and intolerable or which were irreversible or caused participant to be in imminent danger of death.
Time Frame Baseline to 30 days post-week 96 or early termination (ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set composed of all participants who received at least one dose of study medication.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 206
Measure Type: Number
Unit of Measure: Participants
Grade 3 AEs 40
Grade 4 AEs 9
SAEs 34
2.Primary Outcome
Title Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities
Hide Description Grade 3 or severe events included those that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 or very severe events included those that were unacceptable and intolerable or which were irreversible or caused the participant to be in imminent danger of death.
Time Frame Baseline to 30 days post-week 96 or ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set composed of all participants who received at least one dose of study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 206
Measure Type: Number
Unit of Measure: Participants
Grade 3: Alanine aminotransferase (ALT) 0
Grade 3: Aspartate aminotransferase (AST) 4
Grade 3: Absolute neutrophil count (ANC) 7
Grade 3: Alkaline phosphatase 1
Grade 3: Gamma-glutamyl transpeptidase (GGT) 15
Grade 3: Hyperbilirubinemia 17
Grade 3: Hyperuricemia 3
Grade 3: Lipase (n= 101) 8
Grade 3: Platelets 3
Grade 3: Potassium (Hyperkalemia) 0
Grade 3: Serum amylase 12
Grade 4: Alanine aminotransferase (ALT) 1
Grade 4: Aspartate aminotransferase (AST) 0
Grade 4: Absolute neutrophil count (ANC) 4
Grade 4: Alkaline phosphatase 0
Grade 4: Gamma-glutamyl transpeptidase (GGT) 8
Grade 4: Hyperbilirubinemia 6
Grade 4: Hyperuricemia 1
Grade 4: Lipase (n= 101) 2
Grade 4: Platelets 0
Grade 4: Potassium (Hyperkalemia) 2
Grade 4: Serum amylase 1
3.Primary Outcome
Title Number of Participants With Treatment Emergent Malignancies
Hide Description [Not Specified]
Time Frame Baseline to 30 days post-week 96 or ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set composed of all participants who received at least one dose of study medication.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 206
Measure Type: Number
Unit of Measure: Participants
Carcinoma in situ 1
Hodgkin's disease 1
Intestinal T-cell lymphoma 1
Neoplasm of appendix 1
4.Primary Outcome
Title Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections
Hide Description Number of participants with AIDS-related infections based on investigator classification guided by a predefined list of clinical Category C AEs per Center for Disease Control (CDC) HIV Classification System.
Time Frame Baseline to 30 days post-week 96 or ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set composed of all participants who received at least one dose of study medication.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 206
Measure Type: Number
Unit of Measure: Participants
Cerebral toxoplasmosis 2
Disseminated cryptococcosis 1
Oesophageal candidiasis 3
Pneumocystis jiroveci pneumonia 3
Leukoencephalopathy 1
5.Primary Outcome
Title Number of Participants With Laboratory Test Abnormalities
Hide Description Pre-defined criteria based on upper limit normal (ULN) and lower limit normal (LLN) were established for each laboratory test to define the values that would be identified as laboratory test abnormality.
Time Frame Baseline to 30 days post-week 96 or ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set composed of all participants who received at least one dose of study medication.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 206
Measure Type: Number
Unit of Measure: Participants
Hematocrit (<0.8*LLN) 13
Red blood cell count (<0.8*LLN) 35
White blood cell count (<0.6*LLN) 7
White blood cell count (>1.5*ULN) 4
Absolute lymphocytes (<0.8*LLN) 12
Absolute lymphocytes (>1.2*ULN) 60
Percent lymphocytes (<0.8*LLN) (n= 1) 0
Percent lymphocytes (>1.2*ULN) (n= 1) 1
Percent neutrophils (<0.8*LLN) (n= 1) 1
Percent neutrophils (>1.2*ULN) (n= 1) 0
Absolute basophils (>1.2*ULN) 10
Percent basophils (>1.2*ULN) (n= 1) 0
Absolute eosinophils (>1.2*ULN) 32
Percent eosinophils (>1.2*ULN) (n= 1) 0
Absolute monocytes (>1.2*ULN) 25
Percent monocytes (>1.2*ULN) (n= 1) 0
Direct Bilirubin (>1.5*ULN) 67
Indirect bilirubin (>1.5*ULN) 25
Lactose dehydrogenase (LDH) (>3.0*ULN) 1
Total protein (<0.8*LLN) 1
Total protein (>1.2*ULN) 19
Albumin (<0.8*LLN) 3
Albumin (>1.2*ULN) 0
Blood urea nitrogen (BUN) (>1.3*ULN) 7
Cholesterol (>1.3*ULN) 26
High density lipoprotein cholesterol (<0.8*LLN) 115
Low density lipoprotein cholesterol (>1.2*ULN) 101
Triglycerides (>1.3*ULN) 145
Calcium (<0.9*LLN) 6
Calcium (>1.1*ULN) 0
Creatine kinase (CK) (>2.0*ULN) 50
6.Secondary Outcome
Title Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA)
Hide Description [Not Specified]
Time Frame Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or end of treatment (EOT)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who had taken at least one dose of study drug and provided any post-baseline efficacy evaluation. The 'n' signifies those participants who received study drug and were evaluated for this measure at time point for each group respectively. Last Observation Carried Forward (LOCF) method was used.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 206
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 (n= 202) 78.7
Week 8 (n= 196) 78.6
Week 12 (n= 190) 80.5
Week 24 (n= 185) 79.5
Week 36 (n= 171) 83.6
Week 48 (n= 158) 82.3
Week 60 (n= 141) 84.4
Week 72 (n= 137) 81.0
Week 84 (n= 125) 82.4
Week 96 or EOT (n= 109) 89.9
LOCF (n= 206) 76.2
7.Secondary Outcome
Title Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA
Hide Description [Not Specified]
Time Frame Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 206
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 (n= 202) 67.8
Week 8 (n= 196) 68.9
Week 12 (n= 190) 71.1
Week 24 (n= 185) 68.6
Week 36 (n= 171) 69.0
Week 48 (n= 158) 70.3
Week 60 (n= 141) 70.2
Week 72 (n= 137) 64.2
Week 84 (n= 125) 71.2
Week 96 or EOT (n= 109) 72.5
LOCF (n= 206) 61.2
8.Secondary Outcome
Title Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification
Hide Description Below limit of quantification was defined as less than 400 copies/milliliter (mL)
Time Frame Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 206
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 2.4
Week 4 (n= 202) 29.7
Week 8 (n= 196) 43.9
Week 12 (n= 190) 42.6
Week 24 (n= 185) 41.1
Week 36 (n= 171) 47.4
Week 48 (n= 158) 41.1
Week 60 (n= 141) 36.2
Week 72 (n= 137) 24.8
Week 84 (n= 125) 23.2
Week 96 or EOT (n= 109) 33.9
LOCF (n= 206) 26.7
9.Secondary Outcome
Title Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Hide Description [Not Specified]
Time Frame Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 202
Mean (Standard Deviation)
Unit of Measure: cells per microliter (cells/µL)
Baseline 215.6  (179.9)
Change at Week 4 (n= 190) 93.5  (96.7)
Change at Week 8 (n= 190) 110.0  (95.2)
Change at Week 12 (n= 186) 132.1  (164.1)
Change at Week 24 (n= 184) 137.3  (115.0)
Change at Week 36 (n= 165) 157.8  (128.4)
Change at Week 48 (n= 154) 172.2  (124.0)
Change at Week 60 (n= 134) 187.2  (140.4)
Change at Week 72 (n= 129) 199.8  (161.0)
Change at Week 84 (n= 124) 198.2  (177.3)
Change at Week 96 or EOT (n= 107) 225.2  (175.3)
Change at LOCF (n= 201) 174.1  (168.5)
10.Secondary Outcome
Title Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Hide Description [Not Specified]
Time Frame Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 202
Mean (Standard Deviation)
Unit of Measure: cells/µL
Baseline 1016.4  (676.3)
Change at Week 4 (n= 190) 387.3  (597.0)
Change at Week 8 (n= 190) 518.3  (666.4)
Change at Week 12 (n= 186) 507.2  (685.6)
Change at Week 24 (n= 185) 358.1  (577.2)
Change at Week 36 (n= 165) 352.3  (545.3)
Change at Week 48 (n= 155) 348.6  (591.0)
Change at Week 60 (n= 135) 349.1  (566.7)
Change at Week 72 (n= 130) 272.4  (594.8)
Change at Week 84 (n= 124) 246.7  (567.3)
Change at Week 96 or EOT (n= 107) 214.5  (593.2)
Change at LOCF (n= 201) 223.0  (562.0)
11.Secondary Outcome
Title Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Hide Description [Not Specified]
Time Frame Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 202
Mean (Standard Deviation)
Unit of Measure: Percent CD4
Baseline 12.2  (7.5)
Change at Week 4 (n= 190) 1.8  (3.4)
Change at Week 8 (n= 190) 1.3  (3.2)
Change at Week 12 (n= 186) 2.1  (4.4)
Change at Week 24 (n= 184) 2.9  (3.7)
Change at Week 36 (n= 165) 3.6  (3.9)
Change at Week 48 (n= 154) 4.3  (4.1)
Change at Week 60 (n= 134) 4.5  (4.5)
Change at Week 72 (n= 129) 5.2  (4.3)
Change at Week 84 (n= 124) 5.3  (5.2)
Change at Week 96 or EOT (n= 107) 6.6  (5.1)
Change at LOCF (n= 201) 4.9  (5.3)
12.Secondary Outcome
Title Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Hide Description [Not Specified]
Time Frame Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 202
Mean (Standard Deviation)
Unit of Measure: Percent CD8
Baseline 59.8  (13.1)
Change at Week 4 (n= 190) 0.4  (6.1)
Change at Week 8 (n= 190) 0.9  (7.3)
Change at Week 12 (n= 186) -0.1  (8.2)
Change at Week 24 (n= 185) -2.5  (8.3)
Change at Week 36 (n= 165) -3.6  (8.6)
Change at Week 48 (n= 155) -4.3  (9.9)
Change at Week 60 (n= 135) -4.7  (10.4)
Change at Week 72 (n= 130) -6.1  (10.9)
Change at Week 84 (n= 124) -6.8  (10.3)
Change at Week 96 or EOT (n= 107) -7.7  (10.7)
Change at LOCF (n= 201) -5.4  (10.6)
13.Secondary Outcome
Title Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status
Hide Description Virus tropism was done by the Monogram Biosciences Trofile assay.
Time Frame Time of virologic failure (VF) and Week 96 or EOT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 206
Measure Type: Number
Unit of Measure: Participants
VF X4 (n= 134) 7
EOT X4 (n= 146) 8
14.Other Pre-specified Outcome
Title Change From Baseline in Human Immunodeficiency Virus (HIV) -1 Viral Load (Ribonucleic Acid [RNA]) at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Hide Description Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter [log10 copies/ml]).
Time Frame Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who had taken at least one dose of study drug and provided any post-baseline efficacy evaluation. The 'n' signifies those participants who received study drug and were evaluated for this measure at time point for each group respectively. Missing data was imputed using LOCF.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 206
Mean (Standard Deviation)
Unit of Measure: log 10 copies/ml
Baseline 4.8  (0.9)
Change at week 4 (n= 202) -1.5  (1.0)
Change at week 8 (n= 196) -1.5  (1.1)
Change at week 12 (n= 190) -1.6  (1.1)
Change at week 24 (n= 185) -1.6  (1.1)
Change at week 36 (n= 171) -1.6  (1.0)
Change at week 48 (n= 158) -1.6  (1.0)
Change at week 60 (n= 141) -1.6  (1.1)
Change at week 72 (n= 137) -1.4  (1.1)
Change at week 84 (n= 125) -1.5  (1.1)
Change at week 96 or EOT (n= 109) -1.7  (1.0)
Change at LOCF (n= 206) -1.4  (1.1)
15.Other Pre-specified Outcome
Title Time to Virologic Failure (VF)
Hide Description Virologic failure was defined as failing to achieve a reduction in HIV-1 RNA of at least 0.5 log10 copies/ml from baseline by the second viral load determination; or experiencing at least 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline more than 0.5 log10 copies/ml; or experiencing an HIV-1 RNA more than 1000 copies/ml after having achieved an HIV-1 RNA below level of quantification.
Time Frame Baseline to Week 96 or EOT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 206
Median (95% Confidence Interval)
Unit of Measure: Days
255.0
(172.0 to 336.0)
16.Other Pre-specified Outcome
Title Number of Participants With Genotype Resistance
Hide Description Evolution in resistance to OBT was shown by emergence of new primary or secondary resistance mutations to nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI).
Time Frame Baseline through Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. Here, the 'N = 167' is signifying those participants who were evaluable for this measure at the specified time point for this arm group.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
Overall Number of Participants Analyzed 167
Measure Type: Number
Unit of Measure: Participants
VF: NRTI 0
VF: NNRTI 0
VF: PI 16
VF: NRTI and NNRTI 0
VF: NRTI and PI 32
VF: NNRTI and PI 7
VF: NRTI and NNRTI and PI 64
VF: no NRTI, no NNRTI and no PI 0
VF: no test result data 48
Time Frame [Not Specified]
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
Hide Arm/Group Description Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
All-Cause Mortality
Maraviroc
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Maraviroc
Affected / at Risk (%)
Total   34/206 (16.50%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/206 (0.49%) 
Febrile neutropenia * 1  1/206 (0.49%) 
Pancytopenia * 1  1/206 (0.49%) 
Thrombocytopenia * 1  1/206 (0.49%) 
Cardiac disorders   
Bradycardia * 1  1/206 (0.49%) 
Cardio-respiratory arrest * 1  1/206 (0.49%) 
Myocardial ischaemia * 1  1/206 (0.49%) 
Gastrointestinal disorders   
Abdominal pain * 1  2/206 (0.97%) 
Anal fistula * 1  1/206 (0.49%) 
Diarrhoea * 1  2/206 (0.97%) 
Flatulence * 1  1/206 (0.49%) 
Gastrointestinal obstruction * 1  1/206 (0.49%) 
Nausea * 1  1/206 (0.49%) 
Pancreatitis * 1  1/206 (0.49%) 
Vomiting * 1  2/206 (0.97%) 
General disorders   
Fat tissue increased * 1  1/206 (0.49%) 
Gait disturbance * 1  1/206 (0.49%) 
Pyrexia * 1  3/206 (1.46%) 
Hepatobiliary disorders   
Hepatitis * 1  1/206 (0.49%) 
Infections and infestations   
Appendicitis * 1  1/206 (0.49%) 
Bacteraemia * 1  1/206 (0.49%) 
Cerebral toxoplasmosis * 1  1/206 (0.49%) 
Cytomegalovirus infection * 1  1/206 (0.49%) 
Disseminated cryptococcosis * 1  1/206 (0.49%) 
Erysipelas * 1  1/206 (0.49%) 
Keratitis herpetic * 1  1/206 (0.49%) 
Meningitis meningococcal * 1  1/206 (0.49%) 
Pneumocystis jiroveci pneumonia * 1  1/206 (0.49%) 
Pneumonia * 1  3/206 (1.46%) 
Sepsis * 1  4/206 (1.94%) 
Injury, poisoning and procedural complications   
Muscle rupture * 1  1/206 (0.49%) 
Skin laceration * 1  1/206 (0.49%) 
Investigations   
Blood bilirubin increased * 1  1/206 (0.49%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  1/206 (0.49%) 
Metabolic acidosis * 1  1/206 (0.49%) 
Musculoskeletal and connective tissue disorders   
Osteonecrosis * 1  1/206 (0.49%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Carcinoma in situ * 1  1/206 (0.49%) 
Hodgkin’s disease * 1  1/206 (0.49%) 
Intestinal T-cell lymphoma * 1  1/206 (0.49%) 
Neoplasm of appendix * 1  1/206 (0.49%) 
Pseudomyxoma peritonei * 1  1/206 (0.49%) 
Urethral papilloma * 1  1/206 (0.49%) 
Nervous system disorders   
Amnesia * 1  1/206 (0.49%) 
Convulsion * 1  3/206 (1.46%) 
Guillain-Barre syndrome * 1  1/206 (0.49%) 
Ischaemic stroke * 1  1/206 (0.49%) 
Leukoencephalopathy * 1  1/206 (0.49%) 
Monoplegia * 1  1/206 (0.49%) 
Optic neuritis * 1  1/206 (0.49%) 
Psychiatric disorders   
Bradyphrenia * 1  1/206 (0.49%) 
Renal and urinary disorders   
Renal failure acute * 1  1/206 (0.49%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/206 (0.49%) 
Dyspnoea * 1  2/206 (0.97%) 
Hypoxia * 1  1/206 (0.49%) 
Pleural effusion * 1  1/206 (0.49%) 
Pneumonia aspiration * 1  1/206 (0.49%) 
Productive cough * 1  1/206 (0.49%) 
Social circumstances   
Victim of homicide * 1  1/206 (0.49%) 
Vascular disorders   
Haematoma * 1  1/206 (0.49%) 
Venous thrombosis limb * 1  1/206 (0.49%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Maraviroc
Affected / at Risk (%)
Total   185/206 (89.81%) 
Blood and lymphatic system disorders   
Anaemia * 1  8/206 (3.88%) 
Eosinophilia * 1  2/206 (0.97%) 
Granulocytopenia * 1  1/206 (0.49%) 
Leukocytosis * 1  1/206 (0.49%) 
Leukopenia * 1  2/206 (0.97%) 
Lymphadenopathy * 1  7/206 (3.40%) 
Neutropenia * 1  9/206 (4.37%) 
Pancytopenia * 1  1/206 (0.49%) 
Thrombocytopenia * 1  4/206 (1.94%) 
Cardiac disorders   
Arrhythmia * 1  1/206 (0.49%) 
Cardiac failure congestive * 1  1/206 (0.49%) 
Myocardial ischaemia * 1  1/206 (0.49%) 
Congenital, familial and genetic disorders   
Cleft lip * 1  1/206 (0.49%) 
Congenital optic nerve anomaly * 1  1/206 (0.49%) 
Porphyria non-acute * 1  1/206 (0.49%) 
Ear and labyrinth disorders   
Ear disorder * 1  1/206 (0.49%) 
Ear pain * 1  2/206 (0.97%) 
Hypoacusis * 1  1/206 (0.49%) 
Tinnitus * 1  1/206 (0.49%) 
Vertigo * 1  2/206 (0.97%) 
Vestibular disorder * 1  1/206 (0.49%) 
Endocrine disorders   
Hypothyroidism * 1  2/206 (0.97%) 
Eye disorders   
Conjunctival hyperaemia * 1  2/206 (0.97%) 
Conjunctivitis * 1  2/206 (0.97%) 
Conjunctivitis allergic * 1  1/206 (0.49%) 
Dacryostenosis acquired * 1  1/206 (0.49%) 
Eye disorder * 1  1/206 (0.49%) 
Eye pain * 1  2/206 (0.97%) 
Eye pruritus * 1  1/206 (0.49%) 
Ocular hyperaemia * 1  5/206 (2.43%) 
Ocular icterus * 1  4/206 (1.94%) 
Ulcerative keratitis * 1  1/206 (0.49%) 
Gastrointestinal disorders   
Abdominal distension * 1  6/206 (2.91%) 
Abdominal pain * 1  11/206 (5.34%) 
Abdominal pain upper * 1  11/206 (5.34%) 
Aerophagia * 1  1/206 (0.49%) 
Anal fissure * 1  1/206 (0.49%) 
Anal haemorrhage * 1  1/206 (0.49%) 
Anal ulcer * 1  1/206 (0.49%) 
Breath odour * 1  1/206 (0.49%) 
Cheilitis * 1  3/206 (1.46%) 
Constipation * 1  10/206 (4.85%) 
Dental necrosis * 1  1/206 (0.49%) 
Diarrhoea * 1  33/206 (16.02%) 
Dry mouth * 1  2/206 (0.97%) 
Duodenitis * 1  1/206 (0.49%) 
Dyspepsia * 1  4/206 (1.94%) 
Flatulence * 1  8/206 (3.88%) 
Food poisoning * 1  1/206 (0.49%) 
Frequent bowel movements * 1  1/206 (0.49%) 
Gastric disorder * 1  2/206 (0.97%) 
Gastric ulcer * 1  1/206 (0.49%) 
Gastritis * 1  5/206 (2.43%) 
Gastrooesophageal reflux disease * 1  1/206 (0.49%) 
Gingival pain * 1  1/206 (0.49%) 
Gingivitis * 1  1/206 (0.49%) 
Haemorrhoids * 1  5/206 (2.43%) 
Hiatus hernia * 1  1/206 (0.49%) 
Hypoaesthesia oral * 1  1/206 (0.49%) 
Intestinal obstruction * 1  1/206 (0.49%) 
Leukoplakia oral * 1  1/206 (0.49%) 
Lip oedema * 1  1/206 (0.49%) 
Mouth ulceration * 1  1/206 (0.49%) 
Nausea * 1  17/206 (8.25%) 
Odynophagia * 1  1/206 (0.49%) 
Oesophageal ulcer * 1  1/206 (0.49%) 
Oral pain * 1  1/206 (0.49%) 
Parotid gland enlargement * 1  1/206 (0.49%) 
Proctalgia * 1  1/206 (0.49%) 
Rectal discharge * 1  1/206 (0.49%) 
Reflux oesophagitis * 1  1/206 (0.49%) 
Toothache * 1  2/206 (0.97%) 
Vomiting * 1  14/206 (6.80%) 
General disorders   
Administration site pain * 1  1/206 (0.49%) 
Adverse drug reaction * 1  1/206 (0.49%) 
Application site nodule * 1  3/206 (1.46%) 
Application site pain * 1  2/206 (0.97%) 
Asthenia * 1  8/206 (3.88%) 
Chest pain * 1  6/206 (2.91%) 
Chills * 1  1/206 (0.49%) 
Crepitations * 1  2/206 (0.97%) 
Fatigue * 1  1/206 (0.49%) 
Feeling hot * 1  2/206 (0.97%) 
Gait disturbance * 1  1/206 (0.49%) 
Influenza like illness * 1  5/206 (2.43%) 
Injection site erythema * 1  1/206 (0.49%) 
Injection site nodule * 1  9/206 (4.37%) 
Injection site pain * 1  1/206 (0.49%) 
Injection site reaction * 1  1/206 (0.49%) 
Malaise * 1  1/206 (0.49%) 
Nodule * 1  2/206 (0.97%) 
Oedema * 1  2/206 (0.97%) 
Oedema peripheral * 1  6/206 (2.91%) 
Pain * 1  1/206 (0.49%) 
Pyrexia * 1  9/206 (4.37%) 
Ulcer * 1  1/206 (0.49%) 
Xerosis * 1  2/206 (0.97%) 
Hepatobiliary disorders   
Hepatic steatosis * 1  4/206 (1.94%) 
Hepatomegaly * 1  2/206 (0.97%) 
Hepatosplenomegaly * 1  1/206 (0.49%) 
Jaundice * 1  1/206 (0.49%) 
Immune system disorders   
Allergy to arthropod bite * 1  1/206 (0.49%) 
Food allergy * 1  1/206 (0.49%) 
Hypersensitivity * 1  5/206 (2.43%) 
Infections and infestations   
Acarodermatitis * 1  4/206 (1.94%) 
Acute sinusitis * 1  1/206 (0.49%) 
Anal abscess * 1  1/206 (0.49%) 
Anogenital warts * 1  6/206 (2.91%) 
Arthropod infestation * 1  1/206 (0.49%) 
Bacterial diarrhoea * 1  1/206 (0.49%) 
Body tinea * 1  3/206 (1.46%) 
Bronchitis * 1  2/206 (0.97%) 
Bronchitis bacterial * 1  1/206 (0.49%) 
Candidiasis * 1  2/206 (0.97%) 
Cellulitis * 1  3/206 (1.46%) 
Cerebral toxoplasmosis * 1  1/206 (0.49%) 
Cystitis * 1  1/206 (0.49%) 
Dental fistula * 1  1/206 (0.49%) 
Dermatophytosis * 1  3/206 (1.46%) 
Ear infection * 1  2/206 (0.97%) 
Erysipelas * 1  2/206 (0.97%) 
Folliculitis * 1  2/206 (0.97%) 
Fungal infection * 1  1/206 (0.49%) 
Furuncle * 1  3/206 (1.46%) 
Gastroenteritis * 1  3/206 (1.46%) 
Gastrointestinal candidiasis * 1  1/206 (0.49%) 
Genital candidiasis * 1  1/206 (0.49%) 
Genital herpes * 1  8/206 (3.88%) 
HIV infection * 1  1/206 (0.49%) 
Herpes ophthalmic * 1  1/206 (0.49%) 
Herpes simplex * 1  8/206 (3.88%) 
Herpes simplex ophthalmic * 1  1/206 (0.49%) 
Herpes zoster * 1  13/206 (6.31%) 
Herpes zoster ophthalmic * 1  1/206 (0.49%) 
Infection * 1  1/206 (0.49%) 
Influenza * 1  13/206 (6.31%) 
Labyrinthitis * 1  3/206 (1.46%) 
Laryngitis * 1  1/206 (0.49%) 
Lower respiratory tract infection * 1  1/206 (0.49%) 
Lymphogranuloma venereum * 1  1/206 (0.49%) 
Molluscum contagiosum * 1  1/206 (0.49%) 
Nasopharyngitis * 1  32/206 (15.53%) 
Necrotising herpetic retinopathy * 1  1/206 (0.49%) 
Oesophageal candidiasis * 1  3/206 (1.46%) 
Onychomycosis * 1  6/206 (2.91%) 
Oral candidiasis * 1  8/206 (3.88%) 
Oral herpes * 1  3/206 (1.46%) 
Papilloma viral infection * 1  1/206 (0.49%) 
Paronychia * 1  1/206 (0.49%) 
Parotitis * 1  2/206 (0.97%) 
Pneumocystis jiroveci pneumonia * 1  2/206 (0.97%) 
Pneumonia * 1  8/206 (3.88%) 
Pneumonia bacterial * 1  4/206 (1.94%) 
Pneumonia primary atypical * 1  1/206 (0.49%) 
Rash pustular * 1  2/206 (0.97%) 
Rhinitis * 1  1/206 (0.49%) 
Secondary syphilis * 1  1/206 (0.49%) 
Sinusitis * 1  18/206 (8.74%) 
Sinusitis bacterial * 1  1/206 (0.49%) 
Subcutaneous abscess * 1  2/206 (0.97%) 
Syphilis * 1  1/206 (0.49%) 
Tinea cruris * 1  2/206 (0.97%) 
Tinea pedis * 1  5/206 (2.43%) 
Tinea versicolour * 1  2/206 (0.97%) 
Tonsillitis * 1  4/206 (1.94%) 
Tonsillitis bacterial * 1  1/206 (0.49%) 
Tooth abscess * 1  2/206 (0.97%) 
Tooth infection * 1  1/206 (0.49%) 
Tracheobronchitis * 1  5/206 (2.43%) 
Upper respiratory tract infection * 1  17/206 (8.25%) 
Urethritis * 1  1/206 (0.49%) 
Urinary tract infection * 1  1/206 (0.49%) 
Vaginitis bacterial * 1  1/206 (0.49%) 
Viral infection * 1  1/206 (0.49%) 
Viral upper respiratory tract infection * 1  2/206 (0.97%) 
Vulvovaginal candidiasis * 1  1/206 (0.49%) 
Vulvovaginitis * 1  1/206 (0.49%) 
Injury, poisoning and procedural complications   
Arthropod bite * 1  1/206 (0.49%) 
Chest injury * 1  1/206 (0.49%) 
Clavicle fracture * 1  1/206 (0.49%) 
Fall * 1  1/206 (0.49%) 
Foot fracture * 1  1/206 (0.49%) 
Joint sprain * 1  1/206 (0.49%) 
Limb injury * 1  2/206 (0.97%) 
Medication error * 1  2/206 (0.97%) 
Procedural pain * 1  1/206 (0.49%) 
Rib fracture * 1  1/206 (0.49%) 
Scratch * 1  1/206 (0.49%) 
Investigations   
Alanine aminotransferase increased * 1  5/206 (2.43%) 
Aspartate aminotransferase increased * 1  5/206 (2.43%) 
Blood amylase increased * 1  2/206 (0.97%) 
Blood bilirubin increased * 1  6/206 (2.91%) 
Blood creatine phosphokinase increased * 1  13/206 (6.31%) 
Blood creatinine increased * 1  2/206 (0.97%) 
Blood lactate dehydrogenase increased * 1  1/206 (0.49%) 
Blood testosterone decreased * 1  1/206 (0.49%) 
Blood triglycerides increased * 1  4/206 (1.94%) 
Breath sounds abnormal * 1  1/206 (0.49%) 
Gamma-glutamyltransferase increased * 1  2/206 (0.97%) 
High density lipoprotein decreased * 1  7/206 (3.40%) 
Lipase increased * 1  1/206 (0.49%) 
Weight decreased * 1  4/206 (1.94%) 
Weight increased * 1  1/206 (0.49%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  5/206 (2.43%) 
Dehydration * 1  1/206 (0.49%) 
Diabetes mellitus * 1  2/206 (0.97%) 
Dyslipidaemia * 1  1/206 (0.49%) 
Hypercholesterolaemia * 1  1/206 (0.49%) 
Hyperglycaemia * 1  1/206 (0.49%) 
Hypertriglyceridaemia * 1  17/206 (8.25%) 
Hyperuricaemia * 1  4/206 (1.94%) 
Hypoglycaemia * 1  1/206 (0.49%) 
Hypokalaemia * 1  2/206 (0.97%) 
Hypovitaminosis * 1  1/206 (0.49%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  10/206 (4.85%) 
Back pain * 1  8/206 (3.88%) 
Bone pain * 1  2/206 (0.97%) 
Bursitis * 1  1/206 (0.49%) 
Flank pain * 1  2/206 (0.97%) 
Groin pain * 1  1/206 (0.49%) 
Intervertebral disc protrusion * 1  2/206 (0.97%) 
Joint swelling * 1  1/206 (0.49%) 
Muscle spasms * 1  1/206 (0.49%) 
Muscular weakness * 1  1/206 (0.49%) 
Musculoskeletal pain * 1  3/206 (1.46%) 
Myalgia * 1  8/206 (3.88%) 
Neck pain * 1  5/206 (2.43%) 
Osteoarthritis * 1  2/206 (0.97%) 
Osteopenia * 1  1/206 (0.49%) 
Osteoporosis * 1  2/206 (0.97%) 
Pain in extremity * 1  12/206 (5.83%) 
Spinal osteoarthritis * 1  1/206 (0.49%) 
Synovial cyst * 1  1/206 (0.49%) 
Tendonitis * 1  4/206 (1.94%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acrochordon * 1  1/206 (0.49%) 
Benign renal neoplasm * 1  1/206 (0.49%) 
Enchondromatosis * 1  1/206 (0.49%) 
Fibrous histiocytoma * 1  1/206 (0.49%) 
Melanocytic naevus * 1  1/206 (0.49%) 
Oral papilloma * 1  2/206 (0.97%) 
Pyogenic granuloma * 1  1/206 (0.49%) 
Skin papilloma * 1  6/206 (2.91%) 
Uterine leiomyoma * 1  1/206 (0.49%) 
Nervous system disorders   
Anosmia * 1  1/206 (0.49%) 
Carotid artery occlusion * 1  1/206 (0.49%) 
Convulsion * 1  1/206 (0.49%) 
Dizziness * 1  13/206 (6.31%) 
Dysaesthesia * 1  1/206 (0.49%) 
Dysgeusia * 1  2/206 (0.97%) 
Headache * 1  22/206 (10.68%) 
Hyperaesthesia * 1  1/206 (0.49%) 
Hypersomnia * 1  1/206 (0.49%) 
Hypoaesthesia * 1  1/206 (0.49%) 
Memory impairment * 1  1/206 (0.49%) 
Migraine * 1  1/206 (0.49%) 
Monoparesis * 1  1/206 (0.49%) 
Myoclonus * 1  1/206 (0.49%) 
Neuropathy peripheral * 1  4/206 (1.94%) 
Optic neuritis * 1  1/206 (0.49%) 
Post herpetic neuralgia * 1  2/206 (0.97%) 
Sciatica * 1  2/206 (0.97%) 
Sleep phase rhythm disturbance * 1  1/206 (0.49%) 
Somnolence * 1  5/206 (2.43%) 
Psychiatric disorders   
Adjustment disorder with depressed mood * 1  1/206 (0.49%) 
Anxiety * 1  5/206 (2.43%) 
Depression * 1  11/206 (5.34%) 
Disorientation * 1  1/206 (0.49%) 
Impatience * 1  1/206 (0.49%) 
Insomnia * 1  12/206 (5.83%) 
Libido decreased * 1  1/206 (0.49%) 
Libido increased * 1  1/206 (0.49%) 
Nightmare * 1  1/206 (0.49%) 
Stress * 1  1/206 (0.49%) 
Suicidal ideation * 1  1/206 (0.49%) 
Renal and urinary disorders   
Albuminuria * 1  1/206 (0.49%) 
Dysuria * 1  2/206 (0.97%) 
Haematuria * 1  2/206 (0.97%) 
Nephrolithiasis * 1  2/206 (0.97%) 
Nephropathy * 1  1/206 (0.49%) 
Pollakiuria * 1  2/206 (0.97%) 
Proteinuria * 1  1/206 (0.49%) 
Renal colic * 1  1/206 (0.49%) 
Renal cyst * 1  1/206 (0.49%) 
Reproductive system and breast disorders   
Breast cyst * 1  1/206 (0.49%) 
Breast enlargement * 1  1/206 (0.49%) 
Breast pain * 1  1/206 (0.49%) 
Erectile dysfunction * 1  3/206 (1.46%) 
Genital lesion * 1  1/206 (0.49%) 
Gynaecomastia * 1  1/206 (0.49%) 
Haematospermia * 1  1/206 (0.49%) 
Menstruation irregular * 1  1/206 (0.49%) 
Ovarian cyst * 1  1/206 (0.49%) 
Vaginal lesion * 1  1/206 (0.49%) 
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  1/206 (0.49%) 
Bronchospasm * 1  2/206 (0.97%) 
Cough * 1  12/206 (5.83%) 
Dry throat * 1  1/206 (0.49%) 
Dysphonia * 1  1/206 (0.49%) 
Dyspnoea * 1  1/206 (0.49%) 
Nasal ulcer * 1  1/206 (0.49%) 
Oropharyngeal pain * 1  2/206 (0.97%) 
Productive cough * 1  4/206 (1.94%) 
Rhinitis allergic * 1  4/206 (1.94%) 
Throat irritation * 1  1/206 (0.49%) 
Tonsillar disorder * 1  1/206 (0.49%) 
Upper airway obstruction * 1  1/206 (0.49%) 
Wheezing * 1  1/206 (0.49%) 
Skin and subcutaneous tissue disorders   
Acne * 1  3/206 (1.46%) 
Alopecia * 1  2/206 (0.97%) 
Androgenetic alopecia * 1  1/206 (0.49%) 
Chloasma * 1  1/206 (0.49%) 
Dermatitis * 1  2/206 (0.97%) 
Dermatitis allergic * 1  1/206 (0.49%) 
Dermatosis * 1  1/206 (0.49%) 
Drug eruption * 1  3/206 (1.46%) 
Dry skin * 1  2/206 (0.97%) 
Dyshidrosis * 1  1/206 (0.49%) 
Eczema asteatotic * 1  1/206 (0.49%) 
Eosinophilic pustular folliculitis * 1  1/206 (0.49%) 
Erythema * 1  2/206 (0.97%) 
Facial wasting * 1  1/206 (0.49%) 
Intertrigo * 1  1/206 (0.49%) 
Leukoplakia * 1  1/206 (0.49%) 
Lipoatrophy * 1  2/206 (0.97%) 
Lipodystrophy acquired * 1  5/206 (2.43%) 
Lipohypertrophy * 1  2/206 (0.97%) 
Papule * 1  2/206 (0.97%) 
Prurigo * 1  14/206 (6.80%) 
Pruritus * 1  11/206 (5.34%) 
Pruritus allergic * 1  1/206 (0.49%) 
Pruritus generalised * 1  2/206 (0.97%) 
Psoriasis * 1  1/206 (0.49%) 
Rash * 1  15/206 (7.28%) 
Rash erythematous * 1  1/206 (0.49%) 
Rash macular * 1  2/206 (0.97%) 
Rash pruritic * 1  1/206 (0.49%) 
Rosacea * 1  1/206 (0.49%) 
Seborrhoeic dermatitis * 1  6/206 (2.91%) 
Skin exfoliation * 1  2/206 (0.97%) 
Skin lesion * 1  1/206 (0.49%) 
Skin nodule * 1  2/206 (0.97%) 
Skin ulcer * 1  1/206 (0.49%) 
Subcutaneous nodule * 1  22/206 (10.68%) 
Urticaria * 1  1/206 (0.49%) 
Urticaria papular * 1  1/206 (0.49%) 
Surgical and medical procedures   
Mass excision * 1  1/206 (0.49%) 
Varicose vein operation * 1  1/206 (0.49%) 
Vascular disorders   
Arteriosclerosis * 1  1/206 (0.49%) 
Haematoma * 1  2/206 (0.97%) 
Hyperaemia * 1  1/206 (0.49%) 
Hypertension * 1  3/206 (1.46%) 
Hypotension * 1  2/206 (0.97%) 
Orthostatic hypotension * 1  1/206 (0.49%) 
Peripheral arterial occlusive disease * 1  1/206 (0.49%) 
Varicose vein * 1  1/206 (0.49%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
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: NCT00478231     History of Changes
Other Study ID Numbers: A4001063
First Submitted: May 22, 2007
First Posted: May 24, 2007
Results First Submitted: July 8, 2011
Results First Posted: August 8, 2011
Last Update Posted: September 9, 2011