HIV Viral Load Monitoring in Resource-Poor Settings
Effectiveness of HIV Viral Load Monitoring of Patient Outcome in Resource-Poor Settings
1 other identifier
interventional
2,112
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Dec 2006
Longer than P75 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 25, 2009
CompletedFirst Posted
Study publicly available on registry
June 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedOctober 9, 2014
October 1, 2014
5.4 years
June 25, 2009
October 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient survival
36 months
Secondary Outcomes (5)
To assess HIV clinical disease progression (weight, CD4 cell response, incident opportunistic infections)
36 months
To assess the impact of more rapid ART regimen switching on available second and third-line treatment options
36 months
To monitor the effectiveness of newer antiretroviral medications introduced in Zambia (principally tenofovir)
36 months
To characterize the timing and sequence of HIV drug resistance development among patients in each study arm
36 months
To assess the feasibility, acceptability, and cost effectiveness of the two management strategies in a resource-constrained sub-Saharan African setting
36 months
Study Arms (2)
Standard of care
NO INTERVENTIONStandard 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
EXPERIMENTALRoutine 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
Related Publications (1)
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.
PMID: 20300631DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael S. Saag, M.D.
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2009
First Posted
June 29, 2009
Study Start
December 1, 2006
Primary Completion
May 1, 2012
Study Completion
June 1, 2014
Last Updated
October 9, 2014
Record last verified: 2014-10