The purpose of this study is to evaluate and compare the efficacy of immediate antiretroviral therapy versus 2 month deferred anti-Tb therapy upon the clinical course of tuberculosis and HIV infection in patients with AIDS and active tuberculosis.
AIDS and tuberculosis are two international and national priority public health problems. The best time for starting antiretroviral therapy in patients with AIDS and active tuberculosis is not clear, despite of the guidelines regarding CD4+ count. The debate surrounding this issue is mainly due to the difficulty among adherence of anti-MTb and anti-HIV treatment, the pharmacological interaction, the adverse events related to drugs and the risk of inflammatory reconstitution syndrome, especially in patients with advanced HIV infection. Moreover, there is great debate upon the lack of knowledge of the degree of immune reconstitution throughout time against Mtb induced by the anti-HIV therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Receives both, simultaneously antiretroviral therapy and antituberculosis therapy
Receives only antituberculosis therapy and 2 months afterwards antiretroviral therapy
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Centro de Investigaciones en Enfermedades Infecciosas
Mexico City, Mexico City, Mexico
Time to remission of signs and symptoms of active tuberculosis as well as general symptoms.
Time frame: 96 wk
Time to negative measurement of mycobacterial load in body fluids or affected tissues
Time frame: 24 wk
CD4+ cell count increase
Time frame: 24 wk
Lymphoproliferative response to specific antigens against Mtb
Time frame: 24 wk
Time to undetectable HIV plasma load; HIV genotype
Time frame: 24 wk
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.