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

HIV Infections Clinical Trial

— ROTDIP  

Official title:

Multicenter, Open, Pilot Clinical Trial Aimed to Compare the Efficacy of RAL1200 QD vs DRV-cb 800-150 QD Both in Combination With TAF/FTC in Patients With HIV Infection and CD4 Count Under 200 Cells/microL

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03842488
• Other study ID #: FIMHCSVIH-2017
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2019
• Est. completion date: March 2021

Study information

• Verified date: February 2019
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Drug:
• Experimental: RAL QD
Prescription of 2x RAL 600mg (1200MG) once daily
• Active comparator: DRV/cb
Prescription of DARUNAVIR/COBICISTAT 800 Mg-150 Mg once daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud	Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare efficacy of RAL 1200 mg QD versus DRV/cb 800-150 mg QD, both in combination with TAF/FTC	Number of patients that will improve when having raltegravir vs darunavir	48 weeks
Secondary	Virological failure	Number of patients in virological failure at week 48.	48 weeks
Secondary	Compare the proportion of patients who interrupt the treatment for any reason	Number of patients that interrupt the treatment for any reason after 48 weeks.	48 weeks
Secondary	Analyze change (percentage) in the number of CD4 lymphocytes	Percentage of change in the number of CD4 lymphocytes after 48 weeks.	48 weeks
Secondary	Compare the proportion of patients with CD4>200 cells/µL at end of intervention	Compare the proportion of patients with CD4>200 cells/µL at end of intervention.	48 weeks
Secondary	Percentage change in total cholesterol (TC)	Percentage of patients with change in total cholesterol (TC),	48 weeks
Secondary	Percentage change in LDL and HDL cholesterol	Percentage of patients with change in LDL and HDL cholesterol	48 weeks
Secondary	Percentage change in triglycerides	Percentage of patients with change the percentage change in triglycerides after 48 weeks	48 weeks
Secondary	Percentage change in TC/HDL ratio	Percentage of patients with change in TC/HDL ratio	48 weeks
Secondary	Change in Cardiovascular Risk 10-year predictive value (REGICOR).	Percentage of patients with change in Cardiovascular Risk 10-year predictive value (REGICOR).	48 weeks
Secondary	Check GF modification using Chronic Kidney Disease Epidemiology (CKD-EPI) equation	Number of patiens with changes in glomerular filtration using Chronic Kidney Disease Epidemiology (CKD-EPI) equation.	48 weeks