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

NCT03842488 | Unknown Phase 4

• 1 other identifier: FIMHCSVIH-2017
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Virological failure

  48 weeks

• Compare the proportion of patients who interrupt the treatment for any reason

  48 weeks

• Analyze change (percentage) in the number of CD4 lymphocytes

  48 weeks

• Compare the proportion of patients with CD4>200 cells/μL at end of intervention

  48 weeks

• Percentage change in total cholesterol (TC)

  48 weeks

Study Arms (2)

RAL 1200 QD

EXPERIMENTAL

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

Drug: Experimental: RAL QD

DRV/cb

ACTIVE COMPARATOR

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

Drug: Active comparator: DRV/cb

Interventions

Experimental: RAL QD DRUG

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

Also known as: Raltegravir (RAL) 600mg Oral Tablet

RAL 1200 QD

Active comparator: DRV/cb DRUG

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

Also known as: DARUNAVIR/COBICISTAT 800 Mg-150 Mg Oral Tablet

DRV/cb

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium; Tablets; Darunavir; Cobicistat

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Thiazoles; Azoles

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: February 15, 2019
• Study Start: April 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: February 15, 2019

Record last verified: 2019-02