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


  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.
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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


  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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