The VMVN Study: Virological Monitoring in Viet Nam

NCT01317498 | Completed DMC

• 1 other identifier: 2010P000334
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection; AIDS

Keywords

ART; antiretroviral; treatment; Vietnam; Asia; viral load

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Time to identification and diagnosis of treatment failure.

  3 years

• Time from virological treatment failure to switch to second line ART.

  3 years

• Resistance mutations

  3 years

• Sensitivity and specificity of WHO criteria for treatment failure

  3 years

• Cost-benefit analysis

  3 years

Study Arms (2)

Standard Monitoring

PLACEBO COMPARATOR

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

Virological Monitoring

ACTIVE COMPARATOR

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

Interventions

Standard Care OTHER

CD4, liver function and CBC every 6 months

Standard Monitoring

Virological Monitoring OTHER

Viral Load test every 6 months

Virological Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Bach Mai Hospital: collaborator
• Roche Molecular Systems, Inc: collaborator

Study Sites (1)

Bach Mai Hospital

Hanoi, Vietnam

Location

Related Links

• Harvard Medical School AIDS Initiative in Vietnam

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Medicine, Part-time

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 17, 2011
• Study Start: April 1, 2011
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

VN (1)