Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-07-31

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.

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Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Single arm study of combivir and maraviroc for 48 weeks

Group Type EXPERIMENTAL

HIV therapy

Intervention Type DRUG

Combivir one tablet BD with maraviroc 300mg BD for 48 weeks

Interventions

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HIV therapy

Combivir one tablet BD with maraviroc 300mg BD for 48 weeks

Intervention Type DRUG

Other Intervention Names

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Selzentry, Celsentri

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.