Human Immunodeficiency Virus (HIV) infection MedDRA version: 20.1 Level: LLT Classification code 10020442 Term: Human immunodeficiency virus status System Organ Class: 100000004848
Conditions
Interventions
Trade Name: ISENTRESS
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RALTEGRAVIR
CAS Number: 518048-05-0
Other descriptive
Sponsors
FIMABIS Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
APES Costa del Sol (Agencia Pública Empresarial Sanitaria Costa del Sol)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject = 18 years of age. - HIV-1 infection. - Naive to antiretroviral treatment. - CD4 count at the beginning of the study =65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: - Lactating, pregnant or fertile women who do not commit to maintain 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 responsible clinical investigator will decide whether to withdraw or maintain the original treatment and, therefore, whether to withdraw or keep the patient in the study, also being able to decide whether to censure said patient in the efficacy analysis. In any case, if the patient is not removed from the trial, he will remain in the safety analysis. - 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 the compliance of the subject study. - 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-Pough 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
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of patients in virological failure at 48 weeks. - Proportion of patients who interrupt the treatment for any reason at 48 weeks. - Percentage change in the number of CD4 lymphocytes at 48 weeks. - Proportion of patients with CD4> 200 cells / µL at 48 weeks. - Percentage change in total cholesterol, LDL and HDL cholesterol, triglycerides, CT/HDL ratio and RCV at 10 years (Framingham) - Modification of the FG (CKD-EPI) ;Timepoint(s) of evaluation of this end point: At week 48 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the efficacy of RAL 1200 mg QD versus DRV/Cb 800-150 mg QD, both in combination with TAF/FTC in subjects infected with HIV naive with a CD4 count 200 cells/µL at week 48. 5. Evaluate at week 48 the percentage of change in total cholesterol, LDL and HDL cholesterol, triglycerides, CT/HDL ratio and cardiovascular risk predictive value after 10 years (Framingham). 6. Check the modification of the FG (CKD-EPI). | — |
Countries
Spain
Contacts
Public ContactPlataforma de Estudios Clinicos
FIMABIS
Outcome results
None listed