HIV Infections
Conditions
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.
Interventions
DRUGExperimental: RAL QD
Prescription of 2x RAL 600mg (1200MG) once daily
DRUGActive comparator: DRV/cb
Prescription of DARUNAVIR/COBICISTAT 800 Mg-150 Mg once daily
Sponsors
Merck Sharp & Dohme LLC
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare efficacy of RAL 1200 mg QD versus DRV/cb 800-150 mg QD, both in combination with TAF/FTC | 48 weeks | Number of patients that will improve when having raltegravir vs darunavir |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the proportion of patients who interrupt the treatment for any reason | 48 weeks | Number of patients that interrupt the treatment for any reason after 48 weeks. |
| Analyze change (percentage) in the number of CD4 lymphocytes | 48 weeks | 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 | 48 weeks | Compare the proportion of patients with CD4\>200 cells/μL at end of intervention. |
| Percentage change in total cholesterol (TC) | 48 weeks | Percentage of patients with change in total cholesterol (TC), |
| Virological failure | 48 weeks | Number of patients in virological failure at week 48. |
| Percentage change in triglycerides | 48 weeks | Percentage of patients with change the percentage change in triglycerides after 48 weeks |
| Percentage change in TC/HDL ratio | 48 weeks | Percentage of patients with change in TC/HDL ratio |
| Change in Cardiovascular Risk 10-year predictive value (REGICOR). | 48 weeks | Percentage of patients with change in Cardiovascular Risk 10-year predictive value (REGICOR). |
| Check GF modification using Chronic Kidney Disease Epidemiology (CKD-EPI) equation | 48 weeks | Number of patiens with changes in glomerular filtration using Chronic Kidney Disease Epidemiology (CKD-EPI) equation. |
| Percentage change in LDL and HDL cholesterol | 48 weeks | Percentage of patients with change in LDL and HDL cholesterol |
Outcome results
None listed