Clinical trial NCT01317498: The VMVN Study: Virological Monitoring in Viet Nam
Official title: Effect of Routine Viral Load Monitoring on Clinical and Immunological Outcomes and Antiretroviral Drug Resistance on Patients Taking First-line Antiretroviral Drugs in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
AIDS
Keywords: ART
antiretroviral
treatment
Vietnam
Asia
viral load
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Bach Mai Hospital
name: Roche Molecular Systems, Inc
First posted: 2011-03-17
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Death or new/recurrent AIDS-Defining (WHO Clinical Stage IV) Illnesses
timeFrame: 3 years
measure: Virological Suppression
timeFrame: 3 years
Secondary outcomes:
measure: Time to identification and diagnosis of treatment failure.
timeFrame: 3 years
measure: Time from virological treatment failure to switch to second line ART.
timeFrame: 3 years
measure: Resistance mutations
timeFrame: 3 years
measure: Sensitivity and specificity of WHO criteria for treatment failure
timeFrame: 3 years
measure: Cost-benefit analysis
timeFrame: 3 years
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Bach Mai Hospital
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Todd M Pollack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bach Mai Hospital, Hanoi, Vietnam
name: Pham T Thuy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alfred Hospital, Melbourne, Australia
name: Julian Elliott, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Applied Research on Men and Health
name: Donn J Colby, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: