HIV InfectionVMVNNCT01317498
The VMVN Study: Virological Monitoring in Viet Nam
A study testing Virological Monitoring in people with HIV Infection and AIDS, run by Beth Israel Deaconess Medical Center at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, AIDS
- What is being tested?
- Virological Monitoring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 650 participants
- Where
- 1 siteVietnam
- Study dates
- Apr 2011to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- HIV Infection, AIDS
- Being tested
- Standard Care, Virological Monitoring
- Keywords
- ART, antiretroviral, treatment, Vietnam, Asia, viral load
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareOther
CD4, liver function and CBC every 6 months
Virological MonitoringOther
Viral Load test every 6 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Virological Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 years
Secondary outcomes (5)
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.
Measured: 3 years
Time from virological treatment failure to switch to second line ART.
We will calculate the mean time from virological treatment failure to switch to second line ART in both groups.
Measured: 3 years
Resistance mutations
The difference in resistance mutation patterns at the diagnosis of virological treatment failure in each group.
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startApr 2011
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bach Mai Hospital, Roche Molecular Systems, Inc
- Responsible party
- Principal investigator, Todd Pollack, Beth Israel Deaconess Medical Center
- Investigators
- Todd M Pollack, MD, Principal investigator, Beth Israel Deaconess Medical CenterPham T Thuy, MD, PhD, Principal investigator, Bach Mai Hospital, Hanoi, VietnamJulian Elliott, MBBS, PhD, Principal investigator, Alfred Hospital, Melbourne, AustraliaDonn J Colby, MD, MPH, Principal investigator, Center for Applied Research on Men and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317498
- Sponsor's protocol ID
- 2010P000334
- Acronym
- VMVN
- Status last verified
- Aug 2018
- First submitted
- 9 Mar 2011
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01317498
- Acronym / sponsor ID
- VMVN / 2010P000334
- Conditions
- HIV Infection, AIDS
- Keywords
- ART, antiretroviral, treatment, Vietnam, Asia, viral load
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Bach Mai Hospital, Roche Molecular Systems, Inc
- Study start
- Apr 2011 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Monitoring | Placebo comparator | Other: Standard CareThe 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. |
| Virological Monitoring | Active comparator | Other: Virological MonitoringThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard CareCD4, liver function and CBC every 6 months | Other | Standard Monitoring |
| Virological MonitoringViral Load test every 6 months | Other | Virological Monitoring |
Primary outcome
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.
5 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Harvard Medical School AIDS Initiative in VietnamLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd M Pollack, MD principal investigator
Beth Israel Deaconess Medical Center
Pham T Thuy, MD, PhD principal investigator
Bach Mai Hospital, Hanoi, Vietnam
Julian Elliott, MBBS, PhD principal investigator
Alfred Hospital, Melbourne, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virological Monitoring in people with HIV Infection and AIDS, run by Beth Israel Deaconess Medical Center at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or new/recurrent AIDS-Defining (WHO Clinical Stage IV) Illnesses (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.