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

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ClinicalTrials.gov Identifier: NCT01317498
Recruitment Status : Completed
First Posted : March 17, 2011
Last Update Posted : August 3, 2018
Sponsor:
Collaborators:
Bach Mai Hospital
Roche Molecular Systems, Inc
Information provided by (Responsible Party):
Todd Pollack, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE March 9, 2011
First Posted Date  ICMJE March 17, 2011
Last Update Posted Date August 3, 2018
Actual Study Start Date  ICMJE April 2011
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2011)
  • Death or new/recurrent AIDS-Defining (WHO Clinical Stage IV) Illnesses [ Time Frame: 3 years ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01317498 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2012)
  • Time to identification and diagnosis of treatment failure. [ Time Frame: 3 years ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2011)
  • Time to identification and diagnosis of treatment failure. [ Time Frame: 3 years ]
    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 ]
    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 ]
    The presence, number, and types of resistance mutations at the diagnosis of virological treatment failure in each group.
  • Sensitivity and specificity of WHO clinical and immunological criteria for treatment failure [ Time Frame: 3 years ]
    To determine the sensitivity and specificity of WHO clinical and immunological criteria for treatment failure among patients on first-line ARV in Vietnam.
  • Cost-effectiveness [ Time Frame: 3 years ]
    To calculate the cost-effectiveness of routine VL monitoring for patients on first-line ART in Vietnam.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The VMVN Study: Virological Monitoring in Viet Nam
Official Title  ICMJE Effect of Routine Viral Load Monitoring on Clinical and Immunological Outcomes and Antiretroviral Drug Resistance on Patients Taking First-line Antiretroviral Drugs in Vietnam
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infection
  • AIDS
Intervention  ICMJE
  • Other: Standard Care
    CD4, liver function and CBC every 6 months
  • Other: Virological Monitoring
    Viral Load test every 6 months
Study Arms  ICMJE
  • 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.
    Intervention: Other: Standard Care
  • 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.
    Intervention: Other: Virological Monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 16, 2011)
650
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01317498
Other Study ID Numbers  ICMJE 2010P000334
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Todd Pollack, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE
  • Bach Mai Hospital
  • Roche Molecular Systems, Inc
Investigators  ICMJE
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
PRS Account Beth Israel Deaconess Medical Center
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP