This trial is active, not recruiting.

Conditions hiv infection, aids
Treatments standard care, virological monitoring
Sponsor Beth Israel Deaconess Medical Center
Collaborator Bach Mai Hospital
Start date April 2011
End date April 2017
Trial size 650 participants
Trial identifier NCT01317498, 2010P-000334 VMVN


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(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.
standard care
CD4, liver function and CBC every 6 months
(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.
virological monitoring
Viral Load test every 6 months

Primary Outcomes

Death or new/recurrent AIDS-Defining (WHO Clinical Stage IV) Illnesses
time frame: 3 years
Virological Suppression
time frame: 3 years

Secondary Outcomes

Time to identification and diagnosis of treatment failure.
time frame: 3 years
Time from virological treatment failure to switch to second line ART.
time frame: 3 years
Resistance mutations
time frame: 3 years
Sensitivity and specificity of WHO criteria for treatment failure
time frame: 3 years
Cost-benefit analysis
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Todd M Pollack, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.