HIV Viral Load Monitoring in Resource-Poor Settings
|ClinicalTrials.gov Identifier: NCT00929604|
Recruitment Status : Completed
First Posted : June 29, 2009
Last Update Posted : October 9, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV AIDS HIV Infections||Other: HIV-1 viral load testing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effectiveness of HIV Viral Load Monitoring of Patient Outcome in Resource-Poor Settings|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||June 2014|
No Intervention: Standard of care
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.
Experimental: Routine HIV-1 viral load testing
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.
Other: HIV-1 viral load testing
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 Name: Viral load measured by the Roche Amplicor HIV-1 RNA Monitor kit (version 1.5; Roche Molecular Diagnostics, Pleasanton, CA, USA).
- Patient survival [ Time Frame: 36 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929604
|Centre for Infectious Disease Research in Zambia|
|Principal Investigator:||Michael S. Saag, M.D.||University of Alabama at Birmingham|