The VMVN Study: Virological Monitoring in Viet Nam

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborators:
Bach Mai Hospital
Roche Molecular Systems, Inc
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01317498
First received: March 9, 2011
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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 Intervention
HIV Infection
AIDS
Other: Standard Care
Other: Virological Monitoring

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 650
Study Start Date: April 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317498

Contacts
Contact: Pham T Thuy, MD, PhD pham_t_thuy@yahoo.com

Locations
Vietnam
Bach Mai Hospital Recruiting
Hanoi, Vietnam
Principal Investigator: Pham T Thuy, MD, PhD         
Sub-Investigator: Do D Cuong, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Bach Mai Hospital
Roche Molecular Systems, Inc
Investigators
Principal Investigator: Donn J Colby, MD, MPH 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
  More Information

Additional Information:
No publications provided

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01317498     History of Changes
Other Study ID Numbers: 2010P-000334 VMVN
Study First Received: March 9, 2011
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board
Vietnam: Ministry of Health

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

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

ClinicalTrials.gov processed this record on September 29, 2014