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

NCT ID: NCT03842488

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2021-03-31

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RAL 1200 QD

Start treatment with Raltegravir (RAL) 1200mg QD plus tenofovir alafenamide/emtricitabine (FTC/TAF)

Group Type: EXPERIMENTAL

Experimental: RAL QD

Intervention Type: DRUG

Prescription of 2x RAL 600mg (1200MG) once daily

DRV/cb

Start treatment with Darunavir/Cobicistat (DRV/cb) 800-150mg QD plus tenofovir alafenamide/emtricitabine (FTC/TAF)

Group Type: ACTIVE_COMPARATOR

Active comparator: DRV/cb

Intervention Type: DRUG

Prescription of DARUNAVIR/COBICISTAT 800 Mg-150 Mg once daily

Interventions

Experimental: RAL QD

Prescription of 2x RAL 600mg (1200MG) once daily

Intervention Type: DRUG

Active comparator: DRV/cb

Prescription of DARUNAVIR/COBICISTAT 800 Mg-150 Mg once daily

Intervention Type: DRUG

Other Intervention Names

Raltegravir (RAL) 600mg Oral Tablet; DARUNAVIR/COBICISTAT 800 Mg-150 Mg Oral Tablet

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

FIMHCSVIH-2017

Identifier Type: -

Identifier Source: org_study_id