Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275625
• Other study ID #: A4001101
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2011
• Last updated: January 13, 2014
• Start date: June 2011
• Est. completion date: July 2013

Study information

• Verified date: January 2014
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Pharmacological Committee, Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• HIV therapy
Combivir one tablet BD with maraviroc 300mg BD for 48 weeks

Locations

Country	Name	City	State
Russian Federation	Regional Center on AIDS and Infectious Diseases Prophylaxis and Control	Krasnoyarsk
Russian Federation	Federal scientific and methodological center on AIDS prophylaxis and control	Moscow
Russian Federation	Moscow regional center on AIDS and infectious diseases prophylaxis and control	Moscow
Russian Federation	Regional Center on AIDS and Infectious Diseases Prophylaxis and Control	Nizhnij Novgorod
Russian Federation	Federal State Institution Republican clinical infectious hospital of Roszdrav	Saint-Petersburg
Russian Federation	Saint-Petersburg Center on AIDS and Infectious Diseases Prophylaxis and Control	Saint-Petersburg
Russian Federation	Smolensk Center on AIDS and infectious diseases prophylaxis and control	Smolensk
Russian Federation	Volgograd Regional Center on AIDS and Infectious Diseases Prophylaxis and Control	Volgograd

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	Pfizer

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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