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

January 11, 2011
January 13, 2014
June 2011
October 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Participants' responder status at Week 48 was assessed according to Missing, discontinuation= Failure (MDF) algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
Proportion of patients with a viral load <50 copies/mL [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01275625 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    Participants' responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
  • 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 ] [ Designated as safety issue: No ]
    Participants' responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
  • Virologic Response: Rate of Virologic Failure at Week 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Virologic failure defined as: failure to achieve a reduction from baseline in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ. Participants with Time to loss of virologic response (defined by level of <50 copies/mL) failure were classified as rebounders or non-responders.
  • Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+ cell count
  • Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD4+ cell count
  • Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8) [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD8+ cell count.
  • Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8) [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD8+ cell count.
  • 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 ] [ Designated as safety issue: No ]
    Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+/ CD8+ ratio.
  • Number of Participants With Genotypic Resistance. [ Time Frame: Screening to Week 48 or Time of treatment Failure ] [ Designated as safety issue: No ]
    The viral genotypes were captured at Baseline and at treatment failure or Early termination and any resistance-associated mutations summarized descriptively at Week 48 for the Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs)drug classes.
  • 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 ] [ Designated as safety issue: No ]
    Change in tropism were summarized at the time of treatment failure or Early Termination (note: this was performed for participants with viral load > 400 copies/mL only).
  • Safety and tolerability of the regimen of combivir and maraviroc in this patient population [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • To determine the magnitude of changes in CD4+ and CD8+ cell counts and CD4+/CD8+ ratio from baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • To examine the evolution of viral resistance and/or tropism in virologic failure patients infected predominantly with subtype A recombinants of HIV 1. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia
A Multicenter, Open Label Study Of Maraviroc, Zidovudine And Lamivudine Twice Daily For The Treatment Of Antiretroviral Naïve HIV-Infected Patients With R5 HIV-1 In Russia

One hundred subjects in Russia will be treated with a combination of Combivir (zidovudine and lamivudine) and maraviroc as their first line HIV therapy. The aim is to assess the efficacy and safety of this combination in a Russian population of patients.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
Drug: HIV therapy
Combivir one tablet BD with maraviroc 300mg BD for 48 weeks
Other Name: Selzentry, Celsentri
Experimental: Treatment
Single arm study of combivir and maraviroc for 48 weeks
Intervention: Drug: HIV therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
July 2013
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Over 18 years of age.
  • R5 HIV infection on screening tropism test.
  • Viral load >1,000 copies/mL.
  • Never previously treated with anti-HIV medicines.

Exclusion Criteria:

  • Previously treated with anti-HIV medicines.
  • Hepatitis B co-infection.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01275625
A4001101
No
ViiV Healthcare
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP