Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV

Intervention / Treatment
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* Drug: HIV therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Single arm study of combivir and maraviroc for 48 weeks | Drug: HIV therapy<br>* Combivir one tablet BD with maraviroc 300mg BD for 48 weeks<br>* Other names: Selzentry, Celsentri;|

What is the study measuring?
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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. | 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. | 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. | 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. | 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) | 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) | 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) | 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) | 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. | 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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maraviroc, naive, hiv, zidovudine, lamivudine, combivir, Clade A