Status:
COMPLETED
HIV Viral Load Monitoring in Resource-Poor Settings
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Adult AIDS Clinical Trials Group
Conditions:
HIV
AIDS
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
2112 Patients enrolled
Trial Details
Trial ID
NCT00929604
Start Date
December 1 2006
End Date
June 1 2014
Last Update
October 9 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia