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
  Purpose

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.


Condition Intervention Phase
HIV
Drug: HIV therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 98
Study Start Date: June 2011
Study Completion Date: July 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Single arm study of combivir and maraviroc for 48 weeks
Drug: HIV therapy
Combivir one tablet BD with maraviroc 300mg BD for 48 weeks
Other Name: Selzentry, Celsentri

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275625

Locations
Russian Federation
Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
Krasnoyarsk, Russian Federation, 660049
Federal scientific and methodological center on AIDS prophylaxis and control
Moscow, Russian Federation, 105275
Moscow regional center on AIDS and infectious diseases prophylaxis and control
Moscow, Russian Federation, 129110
Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
Nizhnij Novgorod, Russian Federation, 603005
Federal State Institution Republican clinical infectious hospital of Roszdrav
Saint-Petersburg, Russian Federation, 196645
Saint-Petersburg Center on AIDS and Infectious Diseases Prophylaxis and Control
Saint-Petersburg, Russian Federation, 190103
Smolensk Center on AIDS and infectious diseases prophylaxis and control
Smolensk, Russian Federation, 214006
Volgograd Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
Volgograd, Russian Federation, 400040
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01275625     History of Changes
Other Study ID Numbers: A4001101
Study First Received: January 11, 2011
Results First Received: September 23, 2013
Last Updated: January 13, 2014
Health Authority: Russia: Pharmacological Committee, Ministry of Health

Keywords provided by ViiV Healthcare:
maraviroc
naive
hiv
zidovudine
lamivudine
combivir
Clade A

ClinicalTrials.gov processed this record on October 28, 2014