Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine (MERIT)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00098293
First received: December 6, 2004
Last updated: August 7, 2013
Last verified: August 2013
Results First Received: July 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV-1
Interventions: Drug: Maraviroc + Zidovudine/Lamivudine
Drug: Efavirenz + Zidovudine/Lamivudine
Drug: Maraviroc (UK-427,857) + Zidovudine/Lamivudine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Data Safety Monitoring Board (DSMB) recommended termination of maraviroc once daily treatment after interim analysis at nominal week 16, 130 participants of 177 randomized were switched to open-label (OL) maraviroc twice daily.

Reporting Groups
  Description
Maraviroc Once Daily + CBV (DB) Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant’s Week 96 visit.
Maraviroc Twice Daily + CBV (DB and OL) Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
Efavirenz Once Daily + CBV (DB and OL) Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase.
Maraviroc Twice Daily + CBV (OL) Participants who received maraviroc 300 mg tablet orally once daily treatment during the DB phase and who were eligible based on safety criteria and virologic response, switched to OL maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, following the DSMB recommendation to terminate the maraviroc once daily treatment arm after planned interim analysis. OL phase continued for at least 3 years after DB phase.
Maraviroc Twice Daily + CBV (SP) Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available.

Participant Flow for 4 periods

Period 1:   Double-blind (DB) Phase
    Maraviroc Once Daily + CBV (DB)   Maraviroc Twice Daily + CBV (DB and OL)   Efavirenz Once Daily + CBV (DB and OL)   Maraviroc Twice Daily + CBV (OL)   Maraviroc Twice Daily + CBV (SP)
STARTED   177   368   372   0   0 
Treated   174   360   361   0   0 
COMPLETED   0   202   202   0   0 
NOT COMPLETED   177   166   170   0   0 
Adverse Event                14                27                60                0                0 
Pregnancy                0                7                9                0                0 
Participant Defaulted                11                40                36                0                0 
Lack of Efficacy                11                64                30                0                0 
Death                1                2                2                0                0 
Randomized, Not Treated                3                8                11                0                0 
Protocol Violation                2                18                22                0                0 
Terminated by sponsor                135                0                0                0                0 

Period 2:   Between DB and OL Phase
    Maraviroc Once Daily + CBV (DB)   Maraviroc Twice Daily + CBV (DB and OL)   Efavirenz Once Daily + CBV (DB and OL)   Maraviroc Twice Daily + CBV (OL)   Maraviroc Twice Daily + CBV (SP)
STARTED   0   202   202   0   0 
COMPLETED   0   202   199   0   0 
NOT COMPLETED   0   0   3   0   0 
Did Not Enter Open-label Phase                0                0                3                0                0 

Period 3:   Open-label (OL) Phase
    Maraviroc Once Daily + CBV (DB)   Maraviroc Twice Daily + CBV (DB and OL)   Efavirenz Once Daily + CBV (DB and OL)   Maraviroc Twice Daily + CBV (OL)   Maraviroc Twice Daily + CBV (SP)
STARTED   0   202   199   130   0 
COMPLETED   0   177   158   65   0 
NOT COMPLETED   0   25   41   65   0 
Adverse Event                0                3                7                6                0 
Lack of Efficacy                0                7                2                20                0 
Pregnancy                0                1                0                3                0 
Protocol Violation                0                6                13                16                0 
Participant Defaulted                0                6                16                20                0 
Death                0                2                3                0                0 

Period 4:   Supplemental Phase (SP)
    Maraviroc Once Daily + CBV (DB)   Maraviroc Twice Daily + CBV (DB and OL)   Efavirenz Once Daily + CBV (DB and OL)   Maraviroc Twice Daily + CBV (OL)   Maraviroc Twice Daily + CBV (SP)
STARTED   0   0   0   0   127 
COMPLETED   0   0   0   0   94 
NOT COMPLETED   0   0   0   0   33 
Death                0                0                0                0                1 
Lost to Follow-up                0                0                0                0                2 
Withdrawal by Subject                0                0                0                0                8 
Unspecified                0                0                0                0                22 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Maraviroc Once Daily + CBV (DB) Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant’s Week 96 visit.
Maraviroc Twice Daily + CBV (DB and OL) Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
Efavirenz Once Daily + CBV (DB and OL) Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, up to week 96 in DB phase. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily from Week 97 up to Week 240 in open-label (OL) phase.
Total Total of all reporting groups

Baseline Measures
   Maraviroc Once Daily + CBV (DB)   Maraviroc Twice Daily + CBV (DB and OL)   Efavirenz Once Daily + CBV (DB and OL)   Total 
Overall Participants Analyzed 
[Units: Participants]
 174   360   361   895 
Age, Customized 
[Units: Participants]
       
Less than 18 years   0   0   0   0 
18 to 24 years   17   24   25   66 
25 to 34 years   47   147   120   314 
35 to 44 years   73   117   141   331 
45 to 54 years   29   56   55   140 
55 to 64 years   7   14   15   36 
Greater than or equal to 65 years   1   2   5   8 
Gender 
[Units: Participants]
       
Female   44   104   102   250 
Male   130   256   259   645 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population   [ Time Frame: Week 48 ]

2.  Primary:   Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population   [ Time Frame: Week 48 ]

3.  Secondary:   Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression   [ Time Frame: Week 48 ]

4.  Secondary:   Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression   [ Time Frame: Week 96 ]

5.  Secondary:   Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96   [ Time Frame: Baseline, Week 48, Week 96 ]

6.  Secondary:   Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels   [ Time Frame: Baseline up to Week 48 and Week 96 ]

7.  Secondary:   Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96   [ Time Frame: Baseline, Week 48, Week 96 ]

8.  Secondary:   Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96   [ Time Frame: Baseline, Week 48, Week 96 ]

9.  Secondary:   Time to Virologic Failure   [ Time Frame: Week 48, Week 96 ]

10.  Secondary:   Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48   [ Time Frame: Baseline, time of failure through Week 48 ]

11.  Secondary:   Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 96   [ Time Frame: Baseline, time of failure through Week 96 ]

12.  Secondary:   Number of Participants With Phenotypic Resistance at Time of Treatment Failure Through Week 48 and 96   [ Time Frame: Screening, time of failure through Week 48, Week 96 ]

13.  Secondary:   Number of Participants With NRTI Associated Mutations at Time of Treatment Failure Through Week 48 and 96   [ Time Frame: Screening, time of failure through Week 48, Week 96 ]

14.  Secondary:   Number of Participants With Efavirenz Associated Mutations at Time of Treatment Failure Through Week 48 and 96   [ Time Frame: Screening, time of failure through Week 48, Week 96 ]

15.  Secondary:   Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL at Week 48 and Week 96 by Overall Susceptibility Score (OSS) at Screening   [ Time Frame: Baseline, Week 48, Week 96 ]

16.  Other Pre-specified:   Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 96   [ Time Frame: Week 96 ]

17.  Post-Hoc:   Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants   [ Time Frame: Week 48 ]

18.  Post-Hoc:   Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants   [ Time Frame: Week 96 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional 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.

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL) Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
Maraviroc Twice Daily + CBV (DB and OL) Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
Efavirenz Once Daily + CBV (DB and OL) Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase.
Maraviroc Twice Daily + CBV (SP) Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available.

Other Adverse Events
    Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)   Maraviroc Twice Daily + CBV (DB and OL)   Efavirenz Once Daily + CBV (DB and OL)   Maraviroc Twice Daily + CBV (SP)
Total, other (not including serious) adverse events         
# participants affected / at risk   151/174 (86.78%)   319/360 (88.61%)   327/361 (90.58%)   0/127 (0.00%) 
Blood and lymphatic system disorders         
Anaemia * 1         
# participants affected / at risk   12/174 (6.90%)   27/360 (7.50%)   18/361 (4.99%)   0/127 (0.00%) 
Eye disorders         
Conjunctivitis * 1         
# participants affected / at risk   11/174 (6.32%)   11/360 (3.06%)   25/361 (6.93%)   0/127 (0.00%) 
Gastrointestinal disorders         
Abdominal distension * 1         
# participants affected / at risk   12/174 (6.90%)   21/360 (5.83%)   20/361 (5.54%)   0/127 (0.00%) 
Abdominal pain * 1         
# participants affected / at risk   30/174 (17.24%)   53/360 (14.72%)   53/361 (14.68%)   0/127 (0.00%) 
Abdominal pain upper * 1         
# participants affected / at risk   7/174 (4.02%)   22/360 (6.11%)   23/361 (6.37%)   0/127 (0.00%) 
Constipation * 1         
# participants affected / at risk   13/174 (7.47%)   37/360 (10.28%)   20/361 (5.54%)   0/127 (0.00%) 
Diarrhoea * 1         
# participants affected / at risk   46/174 (26.44%)   90/360 (25.00%)   111/361 (30.75%)   0/127 (0.00%) 
Dyspepsia * 1         
# participants affected / at risk   9/174 (5.17%)   26/360 (7.22%)   38/361 (10.53%)   0/127 (0.00%) 
Flatulence * 1         
# participants affected / at risk   10/174 (5.75%)   26/360 (7.22%)   13/361 (3.60%)   0/127 (0.00%) 
Gastritis * 1         
# participants affected / at risk   5/174 (2.87%)   16/360 (4.44%)   22/361 (6.09%)   0/127 (0.00%) 
Haemorrhoids * 1         
# participants affected / at risk   6/174 (3.45%)   25/360 (6.94%)   16/361 (4.43%)   0/127 (0.00%) 
Nausea * 1         
# participants affected / at risk   60/174 (34.48%)   138/360 (38.33%)   132/361 (36.57%)   0/127 (0.00%) 
Vomiting * 1         
# participants affected / at risk   28/174 (16.09%)   53/360 (14.72%)   61/361 (16.90%)   0/127 (0.00%) 
General disorders         
Asthenia * 1         
# participants affected / at risk   17/174 (9.77%)   29/360 (8.06%)   40/361 (11.08%)   0/127 (0.00%) 
Chest pain * 1         
# participants affected / at risk   6/174 (3.45%)   17/360 (4.72%)   25/361 (6.93%)   0/127 (0.00%) 
Fatigue * 1         
# participants affected / at risk   37/174 (21.26%)   64/360 (17.78%)   60/361 (16.62%)   0/127 (0.00%) 
Influenza like illness * 1         
# participants affected / at risk   14/174 (8.05%)   21/360 (5.83%)   22/361 (6.09%)   0/127 (0.00%) 
Pyrexia * 1         
# participants affected / at risk   16/174 (9.20%)   21/360 (5.83%)   30/361 (8.31%)   0/127 (0.00%) 
Infections and infestations         
Bronchitis * 1         
# participants affected / at risk   28/174 (16.09%)   64/360 (17.78%)   49/361 (13.57%)   0/127 (0.00%) 
Gastroenteritis * 1         
# participants affected / at risk   10/174 (5.75%)   27/360 (7.50%)   33/361 (9.14%)   0/127 (0.00%) 
Herpes zoster * 1         
# participants affected / at risk   4/174 (2.30%)   18/360 (5.00%)   16/361 (4.43%)   0/127 (0.00%) 
Influenza * 1         
# participants affected / at risk   15/174 (8.62%)   56/360 (15.56%)   50/361 (13.85%)   0/127 (0.00%) 
Nasopharyngitis * 1         
# participants affected / at risk   24/174 (13.79%)   70/360 (19.44%)   48/361 (13.30%)   0/127 (0.00%) 
Pharyngitis * 1         
# participants affected / at risk   15/174 (8.62%)   24/360 (6.67%)   33/361 (9.14%)   0/127 (0.00%) 
Sinusitis * 1         
# participants affected / at risk   4/174 (2.30%)   29/360 (8.06%)   28/361 (7.76%)   0/127 (0.00%) 
Syphilis * 1         
# participants affected / at risk   10/174 (5.75%)   16/360 (4.44%)   13/361 (3.60%)   0/127 (0.00%) 
Upper respiratory tract infection * 1         
# participants affected / at risk   32/174 (18.39%)   82/360 (22.78%)   78/361 (21.61%)   0/127 (0.00%) 
Urinary tract infection * 1         
# participants affected / at risk   7/174 (4.02%)   15/360 (4.17%)   25/361 (6.93%)   0/127 (0.00%) 
Investigations         
Alanine aminotransferase increased * 1         
# participants affected / at risk   15/174 (8.62%)   20/360 (5.56%)   11/361 (3.05%)   0/127 (0.00%) 
Aspartate aminotransferase increased * 1         
# participants affected / at risk   12/174 (6.90%)   13/360 (3.61%)   12/361 (3.32%)   0/127 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite * 1         
# participants affected / at risk   18/174 (10.34%)   34/360 (9.44%)   36/361 (9.97%)   0/127 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1         
# participants affected / at risk   17/174 (9.77%)   37/360 (10.28%)   30/361 (8.31%)   0/127 (0.00%) 
Back pain * 1         
# participants affected / at risk   18/174 (10.34%)   44/360 (12.22%)   44/361 (12.19%)   0/127 (0.00%) 
Muscle spasms * 1         
# participants affected / at risk   9/174 (5.17%)   16/360 (4.44%)   22/361 (6.09%)   0/127 (0.00%) 
Myalgia * 1         
# participants affected / at risk   14/174 (8.05%)   29/360 (8.06%)   28/361 (7.76%)   0/127 (0.00%) 
Pain in extremity * 1         
# participants affected / at risk   15/174 (8.62%)   27/360 (7.50%)   23/361 (6.37%)   0/127 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Skin papilloma * 1         
# participants affected / at risk   10/174 (5.75%)   6/360 (1.67%)   14/361 (3.88%)   0/127 (0.00%) 
Nervous system disorders         
Dizziness * 1         
# participants affected / at risk   25/174 (14.37%)   62/360 (17.22%)   116/361 (32.13%)   0/127 (0.00%) 
Dysgeusia * 1         
# participants affected / at risk   10/174 (5.75%)   10/360 (2.78%)   11/361 (3.05%)   0/127 (0.00%) 
Headache * 1         
# participants affected / at risk   44/174 (25.29%)   109/360 (30.28%)   105/361 (29.09%)   0/127 (0.00%) 
Paraesthesia * 1         
# participants affected / at risk   7/174 (4.02%)   19/360 (5.28%)   13/361 (3.60%)   0/127 (0.00%) 
Somnolence * 1         
# participants affected / at risk   6/174 (3.45%)   18/360 (5.00%)   13/361 (3.60%)   0/127 (0.00%) 
Psychiatric disorders         
Abnormal dreams * 1         
# participants affected / at risk   20/174 (11.49%)   22/360 (6.11%)   46/361 (12.74%)   0/127 (0.00%) 
Anxiety * 1         
# participants affected / at risk   8/174 (4.60%)   21/360 (5.83%)   26/361 (7.20%)   0/127 (0.00%) 
Depression * 1         
# participants affected / at risk   18/174 (10.34%)   40/360 (11.11%)   28/361 (7.76%)   0/127 (0.00%) 
Insomnia * 1         
# participants affected / at risk   20/174 (11.49%)   48/360 (13.33%)   44/361 (12.19%)   0/127 (0.00%) 
Sleep disorder * 1         
# participants affected / at risk   7/174 (4.02%)   12/360 (3.33%)   19/361 (5.26%)   0/127 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1         
# participants affected / at risk   22/174 (12.64%)   51/360 (14.17%)   66/361 (18.28%)   0/127 (0.00%) 
Oropharyngeal pain * 1         
# participants affected / at risk   9/174 (5.17%)   30/360 (8.33%)   21/361 (5.82%)   0/127 (0.00%) 
Skin and subcutaneous tissue disorders         
Eczema * 1         
# participants affected / at risk   6/174 (3.45%)   9/360 (2.50%)   22/361 (6.09%)   0/127 (0.00%) 
Lipodystrophy acquired * 1         
# participants affected / at risk   7/174 (4.02%)   12/360 (3.33%)   21/361 (5.82%)   0/127 (0.00%) 
Pruritus * 1         
# participants affected / at risk   9/174 (5.17%)   8/360 (2.22%)   26/361 (7.20%)   0/127 (0.00%) 
Rash * 1         
# participants affected / at risk   25/174 (14.37%)   38/360 (10.56%)   56/361 (15.51%)   0/127 (0.00%) 
Vascular disorders         
Hypertension * 1         
# participants affected / at risk   6/174 (3.45%)   25/360 (6.94%)   23/361 (6.37%)   0/127 (0.00%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 14.0



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Following DSMB decision to discontinue maraviroc 300 mg once daily, inferential statistical analyses was performed between maraviroc 300 mg twice daily and efavirenz 600 mg once daily only. Data at Week 24 was not analyzed as planned in protocol.


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