Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia

January 13, 2014 updated by: ViiV Healthcare

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Krasnoyarsk, Russian Federation, 660049
        • Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
      • Moscow, Russian Federation, 105275
        • Federal scientific and methodological center on AIDS prophylaxis and control
      • Moscow, Russian Federation, 129110
        • Moscow regional center on AIDS and infectious diseases prophylaxis and control
      • Nizhnij Novgorod, Russian Federation, 603005
        • Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
      • Saint-Petersburg, Russian Federation, 190103
        • Saint-Petersburg Center on AIDS and Infectious Diseases Prophylaxis and Control
      • Saint-Petersburg, Russian Federation, 196645
        • Federal State Institution Republican clinical infectious hospital of Roszdrav
      • Smolensk, Russian Federation, 214006
        • Smolensk Center on AIDS and infectious diseases prophylaxis and control
      • Volgograd, Russian Federation, 400040
        • Volgograd Regional Center on AIDS and Infectious Diseases Prophylaxis and Control

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Selzentry, Celsentri

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
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
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.
Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
Virologic Response: Rate of Virologic Failure at Week 48.
Time Frame: 48 weeks
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.
48 weeks
Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
Time Frame: Week 48
Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+ cell count
Week 48
Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
Time Frame: Week 48
Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD4+ cell count
Week 48
Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)
Time Frame: Week 48
Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD8+ cell count.
Week 48
Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)
Time Frame: Week 48
Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD8+ cell count.
Week 48
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
Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+/ CD8+ ratio.
Week 48
Number of Participants With Genotypic Resistance.
Time Frame: Screening to Week 48 or Time of treatment Failure
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.
Screening to Week 48 or Time of treatment Failure
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
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).
Screening to Week 48 or Time of treatment Failure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 11, 2011

First Posted (Estimate)

January 12, 2011

Study Record Updates

Last Update Posted (Estimate)

March 3, 2014

Last Update Submitted That Met QC Criteria

January 13, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4001101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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