The VMVN Study: Virological Monitoring in Viet Nam

Beth Israel Lahey Health

Status: Completed

Conditions: AIDS; HIV Infection

Treatments: Other: Virological Monitoring; Other: Standard Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01317498

2010P000334

Details and patient eligibility

About

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.

Full 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.

Enrollment: 650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

650 participants in 2 patient groups, including a placebo group

Standard Monitoring

Placebo Comparator group

Description:

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.

Treatment:

Other: Standard Care

Virological Monitoring

Active Comparator group

Description:

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.

Treatment:

Other: Virological Monitoring