Status:
COMPLETED
Relationship of Viral Resistance Development to CD4 Monitoring Alone or With Viral Load Monitoring
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Acquired Immunodeficiency Syndrome
Resistance
Eligibility:
All Genders
18+ years
Brief Summary
This study will examine whether HIV-infected patients are more likely to develop resistance to antiretroviral therapy if their blood is not monitored for the number of viruses (viral load) in the body...
Detailed Description
Antiretroviral therapy (ART) has become widely available in resource limited settings (RLS) due to large increases in available resources through the President s Emergency Plan for AIDS Relief (PEPFAR...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Willing to provide individual informed consent.
- HIV positive. (HIV status will have been confirmed by recognized external testing centre (e.g., AIC) or if necessary by the IDI lab using Abbott Determine HIV1-2 plus STAT-PAK (Chembio Diagnostic Systems) rapid tests. Unigold (Trinity Biotech) is available for tie-breaker testing if necessary.
- Currently being followed at the Adult Infectious Disease Clinic.
- Patients who are aged 18 years or more.
- Patients who initiated ART therapy at the Adult Infectious Disease Clinic (First line ART regimens include either stavudine or zidovudine).
- Patients who were ART naive at ART initiation (from patient medical record).
- Patients who have been on ART for at least 36 months and no greater than 40 months.
- EXCLUSION CRITERIA:
- Inability or unwillingness to provide individual informed consent.
- Patients currently admitted to Urgent Care facility (severely ill).
- Age less than 18 years.
- Presence of a documented infection within a period of 4 weeks from screening for enrollment.
Exclusion
Key Trial Info
Start Date :
February 7 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 7 2013
Estimated Enrollment :
1012 Patients enrolled
Trial Details
Trial ID
NCT00434070
Start Date
February 7 2007
End Date
February 7 2013
Last Update
December 12 2019
Active Locations (1)
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1
Infectious Diseases Institute
Kampala, Uganda