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

Primary Purpose

HIV Infections

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Experimental: RAL QD

Active comparator: DRV/cb

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RAL 1200 QD

DRV/cb

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Virological failure

Number of patients in virological failure at week 48.

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.

Analyze change (percentage) in the number of CD4 lymphocytes

Percentage of change in the number of CD4 lymphocytes after 48 weeks.

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.

Percentage change in total cholesterol (TC)

Percentage of patients with change in total cholesterol (TC),

Percentage change in LDL and HDL cholesterol

Percentage of patients with change in LDL and HDL cholesterol

Percentage change in triglycerides

Percentage of patients with change the percentage change in triglycerides after 48 weeks

Percentage change in TC/HDL ratio

Percentage of patients with change in TC/HDL ratio

Change in Cardiovascular Risk 10-year predictive value (REGICOR).

Percentage of patients with change in Cardiovascular Risk 10-year predictive value (REGICOR).

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.

Full Information

NCT ID

NCT03842488

First Posted

December 19, 2018

Last Updated

February 14, 2019

Sponsor

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

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT03842488

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 2019 (Anticipated)

Primary Completion Date

March 2021 (Anticipated)

Study Completion Date

March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RAL 1200 QD

Arm Type

Experimental

Arm Description

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

Arm Title

DRV/cb

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Experimental: RAL QD

Other Intervention Name(s)

Raltegravir (RAL) 600mg Oral Tablet

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Active comparator: DRV/cb

Other Intervention Name(s)

DARUNAVIR/COBICISTAT 800 Mg-150 Mg Oral Tablet

Intervention Description

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

Primary Outcome Measure Information:

Title

Compare efficacy of RAL 1200 mg QD versus DRV/cb 800-150 mg QD, both in combination with TAF/FTC

Description

Number of patients that will improve when having raltegravir vs darunavir

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

Virological failure

Description

Number of patients in virological failure at week 48.

Time Frame

48 weeks

Title

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

Description

Number of patients that interrupt the treatment for any reason after 48 weeks.

Time Frame

48 weeks

Title

Analyze change (percentage) in the number of CD4 lymphocytes

Description

Percentage of change in the number of CD4 lymphocytes after 48 weeks.

Time Frame

48 weeks

Title

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

Description

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

Time Frame

48 weeks

Title

Percentage change in total cholesterol (TC)

Description

Percentage of patients with change in total cholesterol (TC),

Time Frame

48 weeks

Title

Percentage change in LDL and HDL cholesterol

Description

Percentage of patients with change in LDL and HDL cholesterol

Time Frame

48 weeks

Title

Percentage change in triglycerides

Description

Percentage of patients with change the percentage change in triglycerides after 48 weeks

Time Frame

48 weeks

Title

Percentage change in TC/HDL ratio

Description

Percentage of patients with change in TC/HDL ratio

Time Frame

48 weeks

Title

Change in Cardiovascular Risk 10-year predictive value (REGICOR).

Description

Percentage of patients with change in Cardiovascular Risk 10-year predictive value (REGICOR).

Time Frame

48 weeks

Title

Check GF modification using Chronic Kidney Disease Epidemiology (CKD-EPI) equation

Description

Number of patiens with changes in glomerular filtration using Chronic Kidney Disease Epidemiology (CKD-EPI) equation.

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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