Status:
ACTIVE_NOT_RECRUITING
Immediate ART in Subjects with Opportunistic Diseases
Lead Sponsor:
Gustavo Reyes-Teran
Conditions:
HIV/AIDS
ANTIRETROVIRAL TREATMENT
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The aim of this study is to compare the clinical response and mortality rate by an opportunistic disease in HIV-infected individuals who start immediate versus conventional antiretroviral therapy. Im...
Detailed Description
Sample size was calculated using formula, of difference in proportions formula using a beta of 0.1, alpha of 0.05 and an expected difference in mortality of 20%, The sample size is 225 subjects in eac...
Eligibility Criteria
Inclusion
- Over 18 years old
- Time from admission to study entry: less than 48 hours
- Confirmed HIV diagnosis or high probability of HIV infection based on a positive HIV rapid test
- Having an opportunistic disease
- Subjects must be naïve to ART or have failed their first or second ART regimen or must have abandoned ART for more than 3 months
Exclusion
- Meningitis due to Cryptococcus spp. or for M. tuberculosis
- Pregnancy
Key Trial Info
Start Date :
February 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT03825523
Start Date
February 18 2019
End Date
September 1 2025
Last Update
November 7 2024
Active Locations (1)
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1
Centro de Investigacion en Enfermedades Infecciosas
México, State of Mexico, Mexico, 14080