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| Name | Class |
|---|---|
| Bach Mai Hospital | OTHER |
| Roche Molecular Systems, Inc | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care | Other | CD4, liver function and CBC every 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to identification and diagnosis of treatment failure. | 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. | 3 years |
| Time from virological treatment failure to switch to second line ART. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bach Mai Hospital | Hanoi | Vietnam |
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| Label | URL |
|---|---|
| Harvard Medical School AIDS Initiative in Vietnam | View source |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Virological Monitoring |
| Other |
Viral Load test every 6 months |
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We will calculate the mean time from virological treatment failure to switch to second line ART in both groups. |
| 3 years |
| Resistance mutations | The difference in resistance mutation patterns at the diagnosis of virological treatment failure in each group. | 3 years |
| Sensitivity and specificity of WHO criteria for treatment failure | To determine the sensitivity and specificity of WHO criteria for treatment failure among patients on first-line ARV in Vietnam. | 3 years |
| Cost-benefit analysis | 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. | 3 years |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |