Status:
COMPLETED
Option B+: Study on Safety, Viral Suppression, and Survival on Second Line ART
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Ministry of Health and Population, Malawi
University of North Carolina
Conditions:
HIV
Infant Exposure to Efavirenz
Eligibility:
FEMALE
16-50 years
Brief Summary
To characterize safety, durability, antiretroviral treatment (ART) resistance, and clinical outcomes for mothers and infants exposed to the efavirenz-based Option B+ regimen for Prevention of Mother t...
Detailed Description
Option B+ is an innovative strategy pioneered within Malawi that provides universal lifelong ART (tenofovir/lamivudine/efavirenz: TDF/3TC/EFV) for pregnant and breastfeeding women to promote maternal ...
Eligibility Criteria
Inclusion
- Female age ≥16 (includes adults and emancipated minors)
- HIV positive by 2 rapid tests approved by the Malawi Ministry of Health
- Willingness to provide informed consent
Exclusion
- Female \<16 years
- HIV negative
- Incapable of providing informed consent
Key Trial Info
Start Date :
May 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
12011 Patients enrolled
Trial Details
Trial ID
NCT02249962
Start Date
May 1 2015
End Date
September 1 2020
Last Update
March 12 2021
Active Locations (1)
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1
UNC Project Malawi
Lilongwe, Malawi