The VMVN Study: Virological Monitoring in Viet Nam
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Death or new/recurrent AIDS-Defining (WHO Clinical Stage IV) Illnesses [ Time Frame: 3 years ] [ Designated as safety issue: No ]The number of deaths and/or new/recurrent WHO Clinical Stage IV clinical illnesses that occur over 3 years of follow-up in each group.
- Virological Suppression [ Time Frame: 3 years ] [ Designated as safety issue: No ]The percentage of patients in each group who are still on treatment at 3 years who have virological suppression, defined as an HIV viral load below the level of laboratory detection.
- Time to identification and diagnosis of treatment failure. [ Time Frame: 3 years ] [ Designated as safety issue: No ]To calculate the difference in times in the 2 groups from the first emergence of active viral replication (defined as a detectable viral load) to identification and diagnosis of treatment failure.
- Time from virological treatment failure to switch to second line ART. [ Time Frame: 3 years ] [ Designated as safety issue: No ]We will calculate the mean time from virological treatment failure to switch to second line ART in both groups.
- Resistance mutations [ Time Frame: 3 years ] [ Designated as safety issue: No ]The difference in resistance mutation patterns at the diagnosis of virological treatment failure in each group.
- Sensitivity and specificity of WHO criteria for treatment failure [ Time Frame: 3 years ] [ Designated as safety issue: No ]To determine the sensitivity and specificity of WHO criteria for treatment failure among patients on first-line ARV in Vietnam.
- Cost-benefit analysis [ Time Frame: 3 years ] [ Designated as safety issue: No ]To evaluate and compare the costs and benefits of adding routine VL testing to standard laboratory monitoring for patients on first-line ART in Vietnam. In the event that the trial shows a benefit in the primary outcome of decreased number of deaths plus WHO Stage 4 clinical events, the analysis will evaluate the cost per life saved and the cost per outcome event avoided. The analysis will also include a cost per quality-adjusted life year saved.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Placebo Comparator: 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.
Other: Standard Care
CD4, liver function and CBC every 6 months
Active Comparator: 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.
Other: Virological Monitoring
Viral Load test every 6 months
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317498
|Bach Mai Hospital|
|Principal Investigator:||Todd M Pollack, MD||Beth Israel Deaconess Medical Center|
|Principal Investigator:||Pham T Thuy, MD, PhD||Bach Mai Hospital, Hanoi, Vietnam|
|Principal Investigator:||Julian Elliott, MBBS, PhD||Alfred Hospital, Melbourne, Australia|
|Principal Investigator:||Donn J Colby, MD, MPH||Center for Applied Research on Men and Health|