HIV InfectionsPhase 4ROTDIPNCT03842488
Raltegravir One Thousand Two Hundred vs Darunavir-cb in Immnunosupressed Patients: ROTDIP Study
A Phase 4 study testing Experimental: RAL QD and Active comparator: DRV/cb in people with HIV Infections, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Experimental: RAL QD and Active comparator: DRV/cb
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to Mar 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
About this study
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
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
Read the 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
- Being tested
- Experimental: RAL QD, Active comparator: DRV/cb
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: RAL QDDrug
Also called Raltegravir (RAL) 600mg Oral Tablet
Prescription of 2x RAL 600mg (1200MG) once daily
Active comparator: DRV/cbDrug
Also called DARUNAVIR/COBICISTAT 800 Mg-150 Mg Oral Tablet
Prescription of DARUNAVIR/COBICISTAT 800 Mg-150 Mg once daily
| Study group | Role | What they receive |
|---|---|---|
| RAL 1200 QD | Experimental | Start treatment with Raltegravir (RAL) 1200mg QD plus tenofovir alafenamide/emtricitabine (FTC/TAF) Receives: Drug: Experimental: RAL QD |
| DRV/cb | Active comparator | Start treatment with Darunavir/Cobicistat (DRV/cb) 800-150mg QD plus tenofovir alafenamide/emtricitabine (FTC/TAF) Receives: Drug: Active comparator: DRV/cb |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 weeks
Secondary outcomes (10)
Virological failure
Number of patients in virological failure at week 48.
Measured: 48 weeks
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.
Measured: 48 weeks
Analyze change (percentage) in the number of CD4 lymphocytes
Percentage of change in the number of CD4 lymphocytes after 48 weeks.
Measured: 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.
Measured: 48 weeks
Percentage change in total cholesterol (TC)
Percentage of patients with change in total cholesterol (TC),
Measured: 48 weeks
Percentage change in LDL and HDL cholesterol
Percentage of patients with change in LDL and HDL cholesterol
Measured: 48 weeks
Percentage change in triglycerides
Percentage of patients with change the percentage change in triglycerides after 48 weeks
Measured: 48 weeks
Percentage change in TC/HDL ratio
Percentage of patients with change in TC/HDL ratio
Measured: 48 weeks
Change in Cardiovascular Risk 10-year predictive value (REGICOR).
Percentage of patients with change in Cardiovascular Risk 10-year predictive value (REGICOR).
Measured: 48 weeks
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.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study startApr 2019 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842488
- Sponsor's protocol ID
- FIMHCSVIH-2017
- Acronym
- ROTDIP
- Status last verified
- Feb 2019
- First submitted
- 19 Dec 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03842488
- Acronym / sponsor ID
- ROTDIP / FIMHCSVIH-2017
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2019 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAL 1200 QD | Experimental | Drug: Experimental: RAL QDStart treatment with Raltegravir (RAL) 1200mg QD plus tenofovir alafenamide/emtricitabine (FTC/TAF) |
| DRV/cb | Active comparator | Drug: Active comparator: DRV/cbStart treatment with Darunavir/Cobicistat (DRV/cb) 800-150mg QD plus tenofovir alafenamide/emtricitabine (FTC/TAF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: RAL QDAlso: Raltegravir (RAL) 600mg Oral TabletPrescription of 2x RAL 600mg (1200MG) once daily | Drug | RAL 1200 QD |
| Active comparator: DRV/cbAlso: DARUNAVIR/COBICISTAT 800 Mg-150 Mg Oral TabletPrescription of DARUNAVIR/COBICISTAT 800 Mg-150 Mg once daily | Drug | DRV/cb |
Primary outcome
Compare efficacy of RAL 1200 mg QD versus DRV/cb 800-150 mg QD, both in combination with TAF/FTC
Time frame: 48 weeks
Number of patients that will improve when having raltegravir vs darunavir
10 secondary outcomes
Virological failure
Time frame: 48 weeks
Compare the proportion of patients who interrupt the treatment for any reason
Time frame: 48 weeks
Analyze change (percentage) in the number of CD4 lymphocytes
Time frame: 48 weeks
Compare the proportion of patients with CD4>200 cells/μL at end of intervention
Time frame: 48 weeks
Percentage change in total cholesterol (TC)
Time frame: 48 weeks
Percentage change in LDL and HDL cholesterol
Time frame: 48 weeks
Percentage change in triglycerides
Time frame: 48 weeks
Percentage change in TC/HDL ratio
Time frame: 48 weeks
Change in Cardiovascular Risk 10-year predictive value (REGICOR).
Time frame: 48 weeks
Check GF modification using Chronic Kidney Disease Epidemiology (CKD-EPI) equation
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental: RAL QD and Active comparator: DRV/cb in people with HIV Infections, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare efficacy of RAL 1200 mg QD versus DRV/cb 800-150 mg QD, both in combination with TAF/FTC (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.