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

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

Status and phase

Unknown

Phase 4

Conditions

HIV Infections

Treatments

Drug: Active comparator: DRV/cb

Drug: Experimental: RAL QD

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03842488

FIMHCSVIH-2017

Details and patient eligibility

About

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

Full 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.

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.