Raltegravir One Thousand two hundred vs Darunavir-cb in Immnunosupressed Patients: ROTDIP Study

Phase 1

• Conditions: Human Immunodeficiency Virus (HIV) infection; MedDRA version: 20.1 Level: LLT Classification code 10020442 Term: Human immunodeficiency virus status System Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-003470-14-ES
• Lead Sponsor: FIMABIS Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-17
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

- Subject = 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified