The VMVN Study: Virological Monitoring in Viet Nam (VMVN)

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection; AIDS
• Intervention / Treatment: Other: Standard Care; Other: Virological Monitoring

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.

• Study Type: Interventional
• Enrollment (Anticipated): 650
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • Bach Mai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death or new/recurrent AIDS-Defining (WHO Clinical Stage IV) Illnesses	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.	3 years
Virological Suppression	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to identification and diagnosis of treatment failure.	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.	3 years
Time from virological treatment failure to switch to second line ART.	We will calculate the mean time from virological treatment failure to switch to second line ART in both groups.	3 years
Resistance mutations	The difference in resistance mutation patterns at the diagnosis of virological treatment failure in each group.	3 years
Sensitivity and specificity of WHO criteria for treatment failure	To determine the sensitivity and specificity of WHO criteria for treatment failure among patients on first-line ARV in Vietnam.	3 years
Cost-benefit analysis	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.	3 years

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Roche Molecular Systems, Inc; Bach Mai Hospital
• Investigators: 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

Publications and helpful links

Helpful Links

• Bach Mai Hospital, Hanoi, Vietnam

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2011
• Primary Completion (ACTUAL): June 30, 2018
• Study Completion (ACTUAL): June 30, 2018

Study Registration Dates

• First Submitted: March 9, 2011
• First Submitted That Met QC Criteria: March 16, 2011
• First Posted (ESTIMATE): March 17, 2011

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: treatment; Vietnam; ART; viral load; Asia; antiretroviral
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 2010P000334