Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia

Phase 4

Completed

Conditions: HIV

Interventions: Drug: HIV therapy

Registration Number: NCT01275625

Lead Sponsor: ViiV Healthcare

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 98

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	HIV therapy	Single arm study of combivir and maraviroc for 48 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.	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.

Secondary Outcome Measures

Name	Time	Method
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.	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.
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.	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.
Virologic Response: Rate of Virologic Failure at Week 48.	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.
Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)	Week 48	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)	Week 48	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)	Week 48	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)	Week 48	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.	Week 48	Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+/ CD8+ ratio.
Number of Participants With Genotypic Resistance.	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.
Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure.	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).

Trial Locations

Locations (7): Moscow regional center on AIDS and infectious diseases prophylaxis and control
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Moscow, Russian Federation
Federal State Institution Republican clinical infectious hospital of Roszdrav
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Saint-Petersburg, Russian Federation
Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
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Nizhnij Novgorod, Russian Federation
Volgograd Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
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Volgograd, Russian Federation
Saint-Petersburg Center on AIDS and Infectious Diseases Prophylaxis and Control
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Saint-Petersburg, Russian Federation
Smolensk Center on AIDS and infectious diseases prophylaxis and control
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Smolensk, Russian Federation
Federal scientific and methodological center on AIDS prophylaxis and control
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Moscow, Russian Federation