HIVNCT00929604
HIV Viral Load Monitoring in Resource-Poor Settings
A study testing HIV-1 viral load testing in people with HIV and AIDS, run by University of Alabama at Birmingham at 1 site in Zambia.
Trial summary
No randomized clinical trial to date has demonstrated a survival benefit of using regular HIV-1 ribonucleic acid (RNA) viral load (VL) testing to monitor patients' responses to antiretroviral therapy (ART) for HIV infection. The measurement of VL is recommended to monitor the response to ART in developed countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, AIDS, HIV Infections
- What is being tested?
- HIV-1 viral load testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,112 participants
- Where
- 1 siteZambia
- Study dates
- Dec 2006to Jun 2014
- 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
- Documented HIV-1 infection (according to local standard rapid testing algorithms)
- Age 18 years or greater
- Able and willing to provide informed consent to participate
- Eligible for antiretroviral therapy per Zambian national guidelines, which are any of the following:
- CD4+ cell count less than 200 cells/mm3;
- WHO Stage IV disease; or
Show all 10Show fewer
- WHO Stage III disease and CD4+ cell count less than 350 cells/mm3
- Residence in the geographical catchment area of the VLS clinic and intent to remain there for the duration of the study
- Willingness to adhere to the study visit schedule and to be followed-up at home in the event of a missed study visit
- Initiating ART on the day of VLS enrollment, informed consent, and baseline blood collection
Who cannot join
- Receipt of more than 7 days (cumulative) of prior antiretroviral therapy at any time prior to study entry, with the exception of zidovudine and/or single dose nevirapine for prevention of mother-to-child transmission;
- Any exposure to antiretroviral therapy in the past one month
- A condition that, in the opinion of the investigators, would interfere with adherence to study requirements (e.g., mental illness or active drug or alcohol use or dependence)
- Serious illness requiring referral to hospital at the time of ART initiation
- For patients seeking care at sites randomized to the standard of care arm: participation in another research protocol that offers routine viral load testing
- Unwillingness to consent to all aspects of study protocol including blood specimen storage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of HIV Viral Load Monitoring of Patient Outcome in Resource-Poor Settings
No randomized clinical trial to date has demonstrated a survival benefit of using regular HIV-1 ribonucleic acid (RNA) viral load (VL) testing to monitor patients' responses to antiretroviral therapy (ART) for HIV infection. The measurement of VL is recommended to monitor the response to ART in developed countries. In resource-constrained settings, the World Health Organization (WHO) does not recommend routine VL testing, in part due to the cost and complex infrastructure needed for reliable results. In these settings, WHO has proposed the use of clinical and CD4+ lymphocyte-based criteria to guide treatment decisions. However, multiple studies have demonstrated the poor performance of these criteria in sub-Saharan Africa and the frequent discordance between immunologic and virologic responses to ART.
The use of routine viral load monitoring should be evaluated in resource-constrained settings. The investigators hypothesize that routine viral load testing of patients on ART will improve patient survival, decrease disease progression and development of drug resistance, and will be feasible and cost-effective for resource-constrained settings.
Read the detailed description
The study 'Effectiveness of HIV Viral Load Monitoring on Patient Outcome in Resource-Poor Settings,' is a dual-arm, cluster randomized trial to evaluate the use of routine plasma HIV-1 VL monitoring to improve survival and decrease HIV disease progression in patients receiving ART. The primary objective is to assess mortality at 36 months among ART naïve patients initiating therapy and receiving care at facilities with access to routine HIV VL testing (at ART initiation, at 3 months and at every 6 months thereafter) compared to those initiating first regimens and receiving care at facilities according to our local standard of care (which uses immunological [i.e. CD4+ lymphocyte count-based]and clinical criteria to diagnose treatment failure, with discretionary VL testing when the two do not agree).
- Conditions
- HIV, AIDS, HIV Infections
- Being tested
- HIV-1 viral load testing
- Keywords
- HIV, AIDS, Zambia, viral load, antiretroviral therapy, cluster randomization, ART monitoring, treatment failure, randomized clinical trial, treatment naive
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV-1 viral load testingOther
Also called Viral load measured by the Roche Amplicor HIV-1 RNA Monitor kit (version 1.5; Roche Molecular Diagnostics, Pleasanton, CA, USA).
Plasma HIV-1 RNA viral load testing performed at ART initiation (baseline) and at 3, 6, 12, 18, 24, 30, and 36 months thereafter. Routine viral load results are provided to clinicians for the management of the participant's HIV treatment.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Standard of care arm: utilizes the current standard of care per Zambian national guidelines to determine treatment failure and eligibility for second-line ART. HIV-1 viral load measurement is performed if the criteria for either immunologic (i.e., CD4+ lymphocyte count-based) or clinical treatment failure are fulfilled. If both immunologic and clinical treatment failure criteria are fulfilled, the ART regimen is changed to second-line without VL testing. |
| Routine HIV-1 viral load testing | Experimental | Routine viral load testing arm: Routine HIV viral load testing at ART initiation (baseline) and at 3, 6, 12, 18, 24, 30 and 36 months thereafter. Receives: Other: HIV-1 viral load testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival
Measured: 36 months
Secondary outcomes (5)
To assess HIV clinical disease progression (weight, CD4 cell response, incident opportunistic infections)
Measured: 36 months
To assess the impact of more rapid ART regimen switching on available second and third-line treatment options
Measured: 36 months
To monitor the effectiveness of newer antiretroviral medications introduced in Zambia (principally tenofovir)
Measured: 36 months
To characterize the timing and sequence of HIV drug resistance development among patients in each study arm
Measured: 36 months
To assess the feasibility, acceptability, and cost effectiveness of the two management strategies in a resource-constrained sub-Saharan African setting
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startDec 2006
- Primary completionMay 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Adult AIDS Clinical Trials Group
- Responsible party
- Sponsor
- Investigators
- Michael S. Saag, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929604
- Sponsor's protocol ID
- VLS
- Status last verified
- Oct 2014
- First submitted
- 25 Jun 2009
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koethe JR, Westfall AO, Luhanga DK, Clark GM, Goldman JD, Mulenga PL, Cantrell RA, Chi BH, Zulu I, Saag MS, Stringer JS. A cluster randomized trial of routine HIV-1 viral load monitoring in Zambia: study design, implementation, and baseline cohort characteristics. PLoS One. 2010 Mar 12;5(3):e9680. doi: 10.1371/journal.pone.0009680.
PubMed 20300631
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of HIV Viral Load Monitoring of Patient Outcome in Resource-Poor Settings
- ClinicalTrials.gov ID
- NCT00929604
- Acronym / sponsor ID
- VLS
- Conditions
- HIV, AIDS, HIV Infections
- Keywords
- HIV, AIDS, Zambia, viral load, antiretroviral therapy, cluster randomization, ART monitoring, treatment failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,112 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Adult AIDS Clinical Trials Group
- Study start
- Dec 2006
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Jun 2009 (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.
No randomized clinical trial to date has demonstrated a survival benefit of using regular HIV-1 ribonucleic acid (RNA) viral load (VL) testing to monitor patients' responses to antiretroviral therapy (ART) for HIV infection. The measurement of VL is recommended to monitor the response to ART in developed countries. In resource-constrained settings, the World Health Organization (WHO) does not recommend routine VL testing, in part due to the cost and complex infrastructure needed for reliable results. In these settings, WHO has proposed the use of clinical and CD4+ lymphocyte-based criteria to guide treatment decisions. However, multiple studies have demonstrated the poor performance of these criteria in sub-Saharan Africa and the frequent discordance between immunologic and virologic responses to ART.
The use of routine viral load monitoring should be evaluated in resource-constrained settings. The investigators hypothesize that routine viral load testing of patients on ART will improve patient survival, decrease disease progression and development of drug resistance, and will be feasible and cost-effective for resource-constrained settings.
Detailed description
The study 'Effectiveness of HIV Viral Load Monitoring on Patient Outcome in Resource-Poor Settings,' is a dual-arm, cluster randomized trial to evaluate the use of routine plasma HIV-1 VL monitoring to improve survival and decrease HIV disease progression in patients receiving ART. The primary objective is to assess mortality at 36 months among ART naïve patients initiating therapy and receiving care at facilities with access to routine HIV VL testing (at ART initiation, at 3 months and at every 6 months thereafter) compared to those initiating first regimens and receiving care at facilities according to our local standard of care (which uses immunological [i.e. CD4+ lymphocyte count-based]and clinical criteria to diagnose treatment failure, with discretionary VL testing when the two do not agree).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Standard of care arm: utilizes the current standard of care per Zambian national guidelines to determine treatment failure and eligibility for second-line ART. HIV-1 viral load measurement is performed if the criteria for either immunologic (i.e., CD4+ lymphocyte count-based) or clinical treatment failure are fulfilled. If both immunologic and clinical treatment failure criteria are fulfilled, the ART regimen is changed to second-line without VL testing. |
| Routine HIV-1 viral load testing | Experimental | Other: HIV-1 viral load testingRoutine viral load testing arm: Routine HIV viral load testing at ART initiation (baseline) and at 3, 6, 12, 18, 24, 30 and 36 months thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Documented HIV-1 infection (according to local standard rapid testing algorithms)
- Age 18 years or greater
- Able and willing to provide informed consent to participate
- Eligible for antiretroviral therapy per Zambian national guidelines, which are any of the following:
- Residence in the geographical catchment area of the VLS clinic and intent to remain there for the duration of the study
Key exclusion criteria (6 listed)
- Receipt of more than 7 days (cumulative) of prior antiretroviral therapy at any time prior to study entry, with the exception of zidovudine and/or single dose nevirapine for prevention of mother-to-child transmission;
- Any exposure to antiretroviral therapy in the past one month
- A condition that, in the opinion of the investigators, would interfere with adherence to study requirements (e.g., mental illness or active drug or alcohol use or dependence)
- Serious illness requiring referral to hospital at the time of ART initiation
- For patients seeking care at sites randomized to the standard of care arm: participation in another research protocol that offers routine viral load testing
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 |
|---|---|---|
| HIV-1 viral load testingAlso: Viral load measured by the Roche Amplicor HIV-1 RNA Monitor kit (version 1.5; Roche Molecular Diagnostics, Pleasanton, CA, USA).Plasma HIV-1 RNA viral load testing performed at ART initiation (baseline) and at 3, 6, 12, 18, 24, 30, and 36 months thereafter. Routine viral load results are provided to clinicians for the management of the participant's HIV treatment. | Other | Routine HIV-1 viral load testing |
Primary outcome
Patient survival
Time frame: 36 months
5 secondary outcomes
To assess HIV clinical disease progression (weight, CD4 cell response, incident opportunistic infections)
Time frame: 36 months
To assess the impact of more rapid ART regimen switching on available second and third-line treatment options
Time frame: 36 months
To monitor the effectiveness of newer antiretroviral medications introduced in Zambia (principally tenofovir)
Time frame: 36 months
To characterize the timing and sequence of HIV drug resistance development among patients in each study arm
Time frame: 36 months
To assess the feasibility, acceptability, and cost effectiveness of the two management strategies in a resource-constrained sub-Saharan African setting
Time frame: 36 months
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 9 Oct 2014.
- Derived from this study: PubMed 20300631Koethe JR, Westfall AO, Luhanga DK, Clark GM, Goldman JD, Mulenga PL, Cantrell RA, Chi BH, Zulu I, Saag MS, Stringer JS. A cluster randomized trial of routine HIV-1 viral load monitoring in Zambia: study design, implementation, and baseline cohort characteristics. PLoS One. 2010 Mar 12;5(3):e9680. doi: 10.1371/journal.pone.0009680.
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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.
Michael S. Saag, M.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV-1 viral load testing in people with HIV and AIDS, run by University of Alabama at Birmingham at 1 site in Zambia.
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 10 inclusion and 6 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 9 Oct 2014. 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 Zambia. 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. 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?
Patient survival (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00929604, which also lists 1 linked publication.
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 9 Oct 2014.