Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01275625
First received: January 11, 2011
Last updated: January 13, 2014
Last verified: January 2014
Results First Received: September 23, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV
Intervention: Drug: HIV therapy

  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
This report presents results of a 48 week study conducted at 8 centers in Russia. A total of 98 subjects were enrolled in the study; however, one site was closed and data from this site was deemed unusable, thus in total 77 subjects were included in the analysis.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Treatment naïve Human Immuno Deficiency Virus (HIV) infected participants aged 18 years at screening were enrolled. Participants were required to meet all eligibility criteria prior to randomization into the study.

Reporting Groups
  Description
Maraviroc+Combivir All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)

Participant Flow:   Overall Study
    Maraviroc+Combivir  
STARTED     77  
Treated     77  
COMPLETED     64  
NOT COMPLETED     13  
Death                 1  
Lack of Efficacy                 2  
Lost to Follow-up                 1  
Withdrawal by Subject                 3  
Protocol Violation                 1  
Adverse Event                 4  
Not specified                 1  



  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+Combivir All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)

Baseline Measures
    Maraviroc+Combivir  
Number of Participants  
[units: participants]
  77  
Age  
[units: Years]
Mean ± Standard Deviation
  35.2  ± 8.3  
Gender  
[units: Participants]
 
Female     26  
Male     51  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.   [ Time Frame: 48 weeks ]

2.  Secondary:   Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48 ]

3.  Secondary:   Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48 ]

4.  Secondary:   Virologic Response: Rate of Virologic Failure at Week 48.   [ Time Frame: 48 weeks ]

5.  Secondary:   Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)   [ Time Frame: Week 48 ]

6.  Secondary:   Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)   [ Time Frame: Week 48 ]

7.  Secondary:   Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)   [ Time Frame: Week 48 ]

8.  Secondary:   Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)   [ Time Frame: Week 48 ]

9.  Secondary:   Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio.   [ Time Frame: Week 48 ]

10.  Secondary:   Number of Participants With Genotypic Resistance.   [ Time Frame: Screening to Week 48 or Time of treatment Failure ]

11.  Secondary:   Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure.   [ Time Frame: Screening to Week 48 or Time of treatment Failure ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Baseline to follow-up period (28 days after the last dose of study)
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Maraviroc+Combivir All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)

Other Adverse Events
    Maraviroc+Combivir  
Total, other (not including serious) adverse events    
# participants affected / at risk     51/77  
Blood and lymphatic system disorders    
Anemia * 1  
# participants affected / at risk     7/77 (9.09%)  
Neutropenia * 1  
# participants affected / at risk     4/77 (5.19%)  
Thrombocytopenia * 1  
# participants affected / at risk     1/77 (1.30%)  
Cardiac disorders    
Angina pectoris * 1  
# participants affected / at risk     1/77 (1.30%)  
Gastrointestinal disorders    
Abnormal faeces * 1  
# participants affected / at risk     2/77 (2.60%)  
Dry mouth * 1  
# participants affected / at risk     1/77 (1.30%)  
Dyspepsia * 1  
# participants affected / at risk     3/77 (3.90%)  
Gastritis * 1  
# participants affected / at risk     1/77 (1.30%)  
Nausea * 1  
# participants affected / at risk     9/77 (11.69%)  
Vomiting * 1  
# participants affected / at risk     4/77 (5.19%)  
Abdominal distension * 2  
# participants affected / at risk     1/77 (1.30%)  
Abdominal pain upper * 2  
# participants affected / at risk     1/77 (1.30%)  
General disorders    
Asthenia * 1  
# participants affected / at risk     2/77 (2.60%)  
Fatigue * 1  
# participants affected / at risk     1/77 (1.30%)  
Malaise * 1  
# participants affected / at risk     8/77 (10.39%)  
Performance status decreased * 1  
# participants affected / at risk     1/77 (1.30%)  
Pyrexia * 1  
# participants affected / at risk     1/77 (1.30%)  
Infections and infestations    
Bronchitis * 1  
# participants affected / at risk     3/77 (3.90%)  
Chronic sinusitis * 1  
# participants affected / at risk     1/77 (1.30%)  
Cystitis * 1  
# participants affected / at risk     1/77 (1.30%)  
Herpes simplex * 1  
# participants affected / at risk     1/77 (1.30%)  
Laryngitis * 1  
# participants affected / at risk     1/77 (1.30%)  
Oral herpes * 1  
# participants affected / at risk     2/77 (2.60%)  
Respiratory tract infection * 1  
# participants affected / at risk     9/77 (11.69%)  
Respiratory tract infection viral * 1  
# participants affected / at risk     5/77 (6.49%)  
Salpingo-oophoritis * 1  
# participants affected / at risk     1/77 (1.30%)  
Tooth infection * 1  
# participants affected / at risk     1/77 (1.30%)  
Vaginitis bacterial * 1  
# participants affected / at risk     1/77 (1.30%)  
Viral rhinitis * 1  
# participants affected / at risk     1/77 (1.30%)  
Pneumonia * 2  
# participants affected / at risk     1/77 (1.30%)  
Investigations    
Alanine aminotransferase increased * 1  
# participants affected / at risk     7/77 (9.09%)  
Aspartate aminotransferase increased * 1  
# participants affected / at risk     6/77 (7.79%)  
Blood pressure increased * 1  
# participants affected / at risk     2/77 (2.60%)  
Weight decreased * 1  
# participants affected / at risk     3/77 (3.90%)  
Amylase increased * 2  
# participants affected / at risk     1/77 (1.30%)  
Heart rate increased * 2  
# participants affected / at risk     1/77 (1.30%)  
Metabolism and nutrition disorders    
Decreased appetite * 1  
# participants affected / at risk     1/77 (1.30%)  
Musculoskeletal and connective tissue disorders    
Myalgia * 1  
# participants affected / at risk     3/77 (3.90%)  
Psoriatic arthropathy * 1  
# participants affected / at risk     1/77 (1.30%)  
Neck pain * 2  
# participants affected / at risk     1/77 (1.30%)  
Pain in extremity * 2  
# participants affected / at risk     1/77 (1.30%)  
Nervous system disorders    
Dizziness * 1  
# participants affected / at risk     1/77 (1.30%)  
Dysgeusia * 1  
# participants affected / at risk     1/77 (1.30%)  
Headache * 1  
# participants affected / at risk     6/77 (7.79%)  
Hypoaesthesia * 1  
# participants affected / at risk     1/77 (1.30%)  
Intercostal neuralgia * 1  
# participants affected / at risk     1/77 (1.30%)  
Neuritis cranial * 1  
# participants affected / at risk     1/77 (1.30%)  
Cervicobrachial syndrome * 2  
# participants affected / at risk     1/77 (1.30%)  
Neuropathy peripheral * 2  
# participants affected / at risk     1/77 (1.30%)  
Psychiatric disorders    
Agitation * 1  
# participants affected / at risk     1/77 (1.30%)  
Drug dependence * 1  
# participants affected / at risk     1/77 (1.30%)  
Renal and urinary disorders    
Neurogenic bladder * 1  
# participants affected / at risk     1/77 (1.30%)  
Respiratory, thoracic and mediastinal disorders    
Rhinitis allergic * 1  
# participants affected / at risk     1/77 (1.30%)  
Dyspnoea * 2  
# participants affected / at risk     1/77 (1.30%)  
Skin and subcutaneous tissue disorders    
Dermatitis * 1  
# participants affected / at risk     1/77 (1.30%)  
Hyperhidrosis * 1  
# participants affected / at risk     1/77 (1.30%)  
Nail psoriasis * 1  
# participants affected / at risk     1/77 (1.30%)  
Psoriasis * 1  
# participants affected / at risk     1/77 (1.30%)  
Rash * 1  
# participants affected / at risk     1/77 (1.30%)  
Seborrhoeic dermatitis * 1  
# participants affected / at risk     1/77 (1.30%)  
Surgical and medical procedures    
Cows milk free diet * 1  
# participants affected / at risk     1/77 (1.30%)  
Vascular disorders    
Essential hypertension * 2  
# participants affected / at risk     1/77 (1.30%)  
Hypertension * 2  
# participants affected / at risk     2/77 (2.60%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA v15.1
2 Term from vocabulary, MedDRAV15.1



  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
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