NCT01317498

The VMVN Study: Virological Monitoring in Viet Nam

Effect of Routine Viral Load Monitoring on Clinical and Immunological Outcomes and Antiretroviral Drug Resistance on Patients Taking First-line Antiretroviral Drugs in Vietnam

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 650 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infection
• AIDS

Interventions

Type	Name	Description
OTHER	Standard Care	CD4, liver function and CBC every 6 months
OTHER	Virological Monitoring	Viral Load test every 6 months

Timeline

• Start date: 2011-04-01
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2011-03-17
• Last updated: 2018-08-03

Locations

1 site across 1 country: Vietnam