Status:
COMPLETED
Impact of Different Integrase Inhibitor Based Regimen on Immune Activation Among HIV naïve Patient (INTATTI)
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
Low viral replication persistence and immune activation remain important therapeutic challenge in the new HAART era. They are associated with more rapid disease progression, increased risk of mortalit...
Detailed Description
INTRODUCTION AND BACKGROUND Combination antiretroviral therapy (cART) controls HIV-1 plasma viral load in most patients, leading to a reduction in morbidity and mortality \[Egger M, BMJ 1997; Detels R...
Eligibility Criteria
Inclusion
- Naïve patients having documented HIV-1 infection, of age 18 years and older
Exclusion
- Patients with diagnosed CVD, diabetes, uncontrolled hypertension (screening systolic blood pressure \>160 mm Hg or diastolic pressure \>90 mm Hg),
- Other systemic inflammatory disease (hepatitis B or C coinfection was allowed)
- Estimated creatinine clearance \<70 mL/min;
- HIV-1 RNA level of \<1000 copies/mL,
- Prior ART use
- Estimated glomerular filtration rate (eGFR) of \<70 mL/min by the Cockcroft-Gault equation
- Liver transaminase levels \<5 times the upper limit of normal
- Absolute neutrophil count of \<1000 neutrophils/mm3
- Platelet count of ≥50 000 platelets/mm3
- Hemoglobin level of ≥8.5 g/dL
- Use of lipid-lowering drugs
- Life expectancy of ≥1 year from the time of enrollment
- AIDS-defining conditions diagnosed within 30 days
- Active infection or malignancy
- Current alcohol or substance use judged to potentially interfere with study compliance
Key Trial Info
Start Date :
September 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03280940
Start Date
September 1 2017
End Date
March 1 2018
Last Update
January 15 2019
Active Locations (1)
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1
AO Spedali Civili di Brescia
Brescia, BS, Italy, 25123