NCT00929604

HIV Viral Load Monitoring in Resource-Poor Settings

Effectiveness of HIV Viral Load Monitoring of Patient Outcome in Resource-Poor Settings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,112 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-12-01
• Primary completion: 2012-05-01
• Completion: 2014-06-01
• First posted: 2009-06-29
• Last updated: 2014-10-09

Locations

1 site across 1 country: Zambia