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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Combivir one tablet BD with maraviroc 300mg BD for 48 weeks
Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
Krasnoyarsk, Russia
Federal scientific and methodological center on AIDS prophylaxis and control
Moscow, Russia
Moscow regional center on AIDS and infectious diseases prophylaxis and control
Moscow, Russia
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.
Time frame: 48 weeks
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.
Time frame: 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.
Time frame: 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.
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Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
Nizhny Novgorod, Russia
Saint-Petersburg Center on AIDS and Infectious Diseases Prophylaxis and Control
Saint Petersburg, Russia
Federal State Institution Republican clinical infectious hospital of Roszdrav
Saint Petersburg, Russia
Smolensk Center on AIDS and infectious diseases prophylaxis and control
Smolensk, Russia
Volgograd Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
Volgograd, Russia
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Screening to Week 48 or Time of treatment Failure