The VMVN Study: Virological Monitoring in Viet Nam

HIV Infection Clinical Trial

— VMVN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317498
• Other study ID #: 2010P000334
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: June 30, 2018

Study information

• Verified date: August 2018
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AIDS
• HIV Infection
• HIV Infections

Intervention

Other:
• Standard Care
CD4, liver function and CBC every 6 months
• Virological Monitoring
Viral Load test every 6 months

Locations

Country	Name	City	State
Vietnam	Bach Mai Hospital	Hanoi

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Bach Mai Hospital, Roche Molecular Systems, Inc

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Resistance mutations	The difference in resistance mutation patterns at the diagnosis of virological treatment failure in each group.	3 years
Secondary	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
Secondary	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

External Links

•   Bach Mai Hospital, Hanoi, Vietnam
•   Harvard Medical School AIDS Initiative in Vietnam