Effect of Routine Viral Load Monitoring on Clinical and Immunological Outcomes and Antiretroviral Drug Resistance on Patients Taking First-line Antiretroviral Drugs in Vietnam
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV Infection
- Sponsor
- Beth Israel Deaconess Medical Center
- Enrollment
- 650
- Locations
- 1
- Primary Endpoint
- Death or new/recurrent AIDS-Defining (WHO Clinical Stage IV) Illnesses
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Todd Pollack
Assistant Professor in Medicine, Part-time
Beth Israel Deaconess Medical Center
Eligibility 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)