The VMVN Study: Virological Monitoring in Viet Nam

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2018-06-30

Brief Summary

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The purpose of the study is to test the hypothesis that the addition of routine viral load testing to the standard laboratory monitoring of HIV patients on first-line antiretroviral treatment (ART) in Vietnam will result in better clinical outcomes for patients.

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Detailed Description

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The optimal strategy for monitoring antiretroviral therapy (ART) in resource-limited settings (RLS) is unknown. In developed countries, routine monitoring with CD4 count and viral load (VL) testing is standard practice. In RLS, however, limitations in the availability of the technology for VL testing, and in financial resources to pay for VL testing, mean that few developing countries provide VL testing as part of the routine monitoring of patients on ART. Instead, ART is monitored primary by clinical examination with CD4 testing where available. This strategy has been endorsed by the most recent WHO guidelines for ART (WHO, 2010).

Standard laboratory monitoring of patients on ART in Vietnam includes CD4 testing every 6 months, where available. In many rural areas of the country, CD4 testing is not available and only clinical monitoring is used.

In this study we will test the hypothesis that routine viral monitoring every 6 months for patients on first-line ART will result in significantly higher rates of virological suppression and decrease the incidence of death or new or recurrent AIDS-defining illnesses by 50% within three years.

Conditions

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HIV Infection AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Monitoring

The patients in the standard monitoring arm will receive routine laboratory monitoring as provided to all patients in public HIV clinics in Vietnam, including CD4 count, complete blood count, and liver functions tests every 6 months.

Group Type PLACEBO_COMPARATOR

Standard Care

Intervention Type OTHER

CD4, liver function and CBC every 6 months

Virological Monitoring

The patients in the virological monitoring arm will have routine laboratory monitoring as in the standard monitoring arm and in addition will have a viral load test performed every 6 months while in treatment. The first test will be done 6 months after initiating ART.

Group Type ACTIVE_COMPARATOR

Virological Monitoring

Intervention Type OTHER

Viral Load test every 6 months

Interventions

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Standard Care

CD4, liver function and CBC every 6 months

Intervention Type OTHER

Virological Monitoring

Viral Load test every 6 months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \>= 18
* Confirmed HIV infection
* Not currently taking ART
* Meets Vietnam MOH criteria for ART (THROUGH OCTOBER 2011:CD4\<250 cells/mm3, WHO Clinical Stage IV, or WHO clinical stage III with CD4\<350 cells/mm3; FROM NOVEMBER 2011: CD4\<350 cells/mm3, OR WHO Clinical Stage III or IV)
* Completes required Vietnam MOH ART adherence training
* Signs written informed consent form

Exclusion Criteria

* Any ART use within the previous 3 months
* History of treatment failure on first-line ART or known resistance to first-line ART.
* Unable or unwilling to give written informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No