Raltegravir One Thousand Two Hundred vs Darunavir-cb in Immnunosupressed Patients: ROTDIP Study

Phase 4

• Conditions: HIV Infections

• Registration Number: NCT03842488
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief Summary

Multicenter, randomized, open label pilot clinical trial with two parallel arms aimed to compare the efficacy of Raltegravir (RAL) 1200mg QD vs Darunavir/Cobicistat (DRV-cb) 800-150mg QD both in combination with alafenamide/emtricitabine (TAF/FTC) in patients with Human Inmunodefficiency Virus (HIV) infection and CD4\<200 cells/microL

Detailed Description

The trial consists of two parallel arms to study the therapeutic success of 48 weeks, tolerability, immunological recovery, persistence of treatment, safety and results reported by the subject in severely immunocompromised HIV infected patients (with an initial CD4 count \<200 cells/μl) naive to antiretroviral therapy.

Included subjects will be randomized two to one (2:1) to RAL 1200mg QD plus FTC/TAF or DRV/cb (800-150mg) plus FTC/TAF.

Study Timeline

• Study First Submitted: 2018-12-19
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-14
• Last Update Submitted: 2019-02-14
• Study First Posted: 2019-02-15
• Last Update Posted: 2019-02-15
• Study Start: 2019-04
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Subjects ≥ 18 years of age.
• HIV-1 infection.
• Naive to antiretroviral treatment.
• CD4 count at the beginning of the study <200 cells/μl.
• Estimated glomerular filtration ≥ 50 mL / min, according to the formula CKD-EPI.
• Grant Informed Consent in writing to participate in the study

Exclusion Criteria

• Breastfeeding, pregnant or women in childbearing age who do not commit to maintain barrier contraceptive measures during the trial.
• Concomitant use of any drug with possible pharmacological interaction with the study drugs that it is advisable to "avoid" through the database for interactions at the University of Liverpool (www.hiv-druginteractions.org).
• Previous use of any antiretroviral for HIV infection.
• Resistance to the study drugs, or presence of any contraindication to use it. The inclusion in the study can be carried out before receiving the result of the resistance test. Once it is received, in case of presenting any mutation of resistance to drugs of the indicated regimen, the patient will be removed from the study and will be offered the best available treatment for their medical condition at that time.
• Therapies that include interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressants at the entrance to the study.
• Current consumption of alcohol or other substances that at the discretion of the investigator may interfere with subject's treatment compliance.
• Subjects who currently participate in any other clinical trial using a research product, with the exception of studies in which the treatment studied has been stopped for more than 12 weeks.
• AIDS event in diagnosis of HIV infection or in the 3 months prior to the inclusion of the study.
• Suspected severe hepatopathy (grades B or C of the Child-Pugh classification), of any origin, according to the clinician.
• Any other clinical condition or previous treatment that, in the investigator's judgment, makes the subject unsuitable for the study or unable to comply with the dosage requirements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare efficacy of RAL 1200 mg QD versus DRV/cb 800-150 mg QD, both in combination with TAF/FTC	48 weeks	Number of patients that will improve when having raltegravir vs darunavir

Secondary Outcome Measures

Name	Time	Method
Change in Cardiovascular Risk 10-year predictive value (REGICOR).	48 weeks	Percentage of patients with change in Cardiovascular Risk 10-year predictive value (REGICOR).
Check GF modification using Chronic Kidney Disease Epidemiology (CKD-EPI) equation	48 weeks	Number of patiens with changes in glomerular filtration using Chronic Kidney Disease Epidemiology (CKD-EPI) equation.
Percentage change in TC/HDL ratio	48 weeks	Percentage of patients with change in TC/HDL ratio
Virological failure	48 weeks	Number of patients in virological failure at week 48.
Compare the proportion of patients who interrupt the treatment for any reason	48 weeks	Number of patients that interrupt the treatment for any reason after 48 weeks.
Compare the proportion of patients with CD4>200 cells/μL at end of intervention	48 weeks	Compare the proportion of patients with CD4\>200 cells/μL at end of intervention.
Percentage change in triglycerides	48 weeks	Percentage of patients with change the percentage change in triglycerides after 48 weeks
Percentage change in LDL and HDL cholesterol	48 weeks	Percentage of patients with change in LDL and HDL cholesterol
Analyze change (percentage) in the number of CD4 lymphocytes	48 weeks	Percentage of change in the number of CD4 lymphocytes after 48 weeks.
Percentage change in total cholesterol (TC)	48 weeks	Percentage of patients with change in total cholesterol (TC),