Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia

ViiV Healthcare

Status and phase: Completed; Phase 4

Conditions: HIV

Treatments: Drug: HIV therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01275625

A4001101

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 1 patient group

Treatment

Experimental group

Description:

Single arm study of combivir and maraviroc for 48 weeks

Treatment:

Drug: HIV therapy