Immediate ART in Subjects With Opportunistic Diseases

HIV/AIDS Clinical Trial

Official title:

Impact of the Timing of Antiretroviral Therapy Initiation (Immediate Versus Early) on the Mortality Rate of HIV/AIDS Patients Hospitalized With an Opportunistic Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03825523
• Other study ID #: C09-18
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2019
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: Centro de Investigación en. Enfermedades Infecciosas, Mexico
• Contact: GUSTAVO MD REYES-TERÁN, M.D.
• Phone: 56667985
• Email: gustavo.reyesteran[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Immediate ART (iART) is defined as starting antiretroviral therapy in the first 48 hours after the hospitalization.

Conventional ART (cART) is defined as starting antiretroviral therapy once the opportunistic infection is under control at the discretion of infectious disease specialist.

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 each group. Informed consent will be obtained. Patients will be allocated to each group (iART or cART) after randomization stratified by the CD4+ T cell count (less or more than 50 cells/mm3).

Plasma viral load and CD4+ T cell count will be measured at study entry and at weeks 2, 4, 12, 24 and 48 after ART initiation. Clinical outcomes will be: mortality at 4, 12, 24, and 48 weeks, length of hospitalization (measured in days), clinical and microbiological cure of the opportunistic disease, incidence and severity of immune reconstitution of inflammatory syndrome (IRIS), and adverse drug reactions and interactions.

Once 50% of the sample size has completed 30 days of follow-up, a preliminary analysis will be conducted to assess safety and efficacy of iART; if differences in the mortality are observed, the study will be terminated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• Meningitis due to Cryptococcus spp. or for M. tuberculosis

• Pregnancy

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• ANTIRETROVIRAL TREATMENT
• HIV Infections
• HIV/AIDS

Intervention

Other:
• iART
After group assignment, ART will be started within the first 48 hours after admission to the hospital. ART regimen will be decided according to each subject´s the clinical characteristics
• cART
After group assignment, ART is started at the discretion of the attending physician. ART regimen will be decided according to each subject´s the clinical characteristics

Locations

Country	Name	City	State
Mexico	Centro de Investigacion en Enfermedades Infecciosas	Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Gustavo Reyes-Teran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Compare mortality rates betweeno two groups according to the timing of ART initiation: immediate antiretroviral therapy (iART) versus conventional antiretroviral therapy (cART)	30 days
Secondary	Assess survival rates	Compare the survival rate of HIV-infected patients on immediate antiretroviral therapy (iART) versus conventional antiretroviral therapy (cART)	90 days since starting antiretroviral therapy (ART)
Secondary	Assess survival rates	Compare the survival rate of HIV-infected patients on immediate antiretroviral therapy (iART) versus conventional antiretroviral therapy (cART)	180 days since starting antiretroviral therapy (ART)
Secondary	Assess survival rates	Compare the survival rate of HIV-infected patients on immediate antiretroviral therapy (iART) versus conventional antiretroviral therapy (cART)	360 days since starting antiretroviral therapy (ART)
Secondary	Length of stay	Compare length of hospitalization between both groups	1 year
Secondary	Asses survival rates by the CD4 count	Compare the survival rate of HIV-infected patients on immediate antiretroviral therapy (iART) versus conventional antiretroviral therapy (cART) stratified by CD4+ T cell count at study entry	90 days
Secondary	Asses survival rates by the CD4 count	Compare the survival rate of HIV-infected patients on immediate antiretroviral therapy (iART) versus conventional antiretroviral therapy (cART) stratified by CD4+ T cell count at study entry	180 days
Secondary	Asses survival rates by the CD4 count	Compare the survival rate of HIV-infected patients on immediate antiretroviral therapy (iART) versus conventional antiretroviral therapy (cART) stratified by CD4+ T cell count at study entry	360 days
Secondary	Viral load	Measure the baseline plasma viral load and evaluate its dynamics after ART initiation in both groups	90 days
Secondary	Viral load	Measure the baseline plasma viral load and evaluate its dynamics after ART initiation in both groups	180 days
Secondary	Viral load	Measure the baseline plasma viral load and evaluate its dynamics after ART initiation in both groups	360 days
Secondary	CD4 T cell counts	Measure CD4+ T cell counts, and evaluate its dynamics after ART initiation in both groups	90 days
Secondary	CD4 T cell counts	Measure CD4+ T cell counts, and evaluate its dynamics after ART initiation in both groups	180 days
Secondary	CD4 T cell counts	Measure CD4+ T cell counts, and evaluate its dynamics after ART initiation in both groups	360 days
Secondary	IRIS	Determine the incidence and severity of IRIS. Severity will be classified as mild or life threatening	48 weeks
Secondary	Adverse reactions	Describe ART-related adverse events, and drug interactions	48 weeks