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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01317498
Recruitment Status : Active, not recruiting
First Posted : March 17, 2011
Last Update Posted : May 4, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
HIV Infection AIDS 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2011
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Resistance mutations [ Time Frame: 3 years ]
    The difference in resistance mutation patterns at the diagnosis of virological treatment failure in each group.

  4. 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.

  5. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317498


Locations
Vietnam
Bach Mai Hospital
Hanoi, Vietnam
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Bach Mai Hospital
Roche Molecular Systems, Inc
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
More Information

Additional Information:
Responsible Party: Todd Pollack, Instructor in Medicine, Part-time, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01317498     History of Changes
Other Study ID Numbers: 2010P000334
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by Todd Pollack, Beth Israel Deaconess Medical Center:
ART
antiretroviral
treatment
Vietnam
Asia
viral load

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases