EFFICACY AND SAFETY OF A SIMPLIFICATION TREATMENT BASED ON DOLUTEGRAVIR AND DARUNAVIR / COBICISTAT VS USUAL TREATMENT IN SUPPRESSED HIV-1-INFECTED PATIENTS WITH MULTIDRUG RESISTANCE.

Phase 1

• Conditions: HIV-1; MedDRA version: 20.1Level: LLTClassification code 10008919Term: Chronic HIV infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-004750-42-ES
• Lead Sponsor: FUNDACIÓ LLUITA CONTRA LA SIDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-21
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. HIV-1 infected patients (=18 years).
2. Confirmed plasma HIV-1 RNA levels < 50 copies/ml for = 6 months preceding the study randomization.
3. Currently ART containing at least 3 of the following antiretroviral drugs for = 6 consecutive months preceding the study randomization: 3TC, FTC, ABC, ZDV, DDI, TDF, TAF, LPV/r, ATV/r, ATV/c, DRV/r, DRV/c, EFV, NVP, ETR, RPV, RAL, ELV/cobi or MVC.
4. Must have historical genotyping tests showing DRM associated with at least two antiretroviral classes according to Stanford dB.
5. Willing and able to be adherent to their cART regimen for the duration of the study (in opinion of physician).
6. If heterosexually active female; using an effective method of contraception (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner*) from 14 days prior to study inclusion and at least 12 weeks after the end of the study; all female volunteers must be willing to undergo urine pregnancy tests at time points specified in the Schedule of Procedures.
7. If heterosexually active male; willing to use an effective method of contraception (anatomical sterility in self) or agree on the use of an effective method of contraception by his partner (hormonal contraception, intra-uterine device (IUD), or anatomical sterility*) from the day of the study inclusion until 12 weeks after the end of the study.
8. Signed informed consent

* condom use nor diaphragma are considered as an additional method of contraception only and cannot be the only method of contraception used as not been considered an effective method by the Clinical Trial Facilitation Group (CTFG) guidelines.
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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with any DRM associated to INSTI (i.e. T66I, 74M, E92Q, T97A, F121Y, E138A/K, G140A/S, Y143R/H/C, S147G, Q148H/K/R, N155H AND R263K) in historical genotyping tests.
2. Patients with any evidence of previous virologic failure to INSTI-based regimens (with or without drm in the integrase).
3. Patients who have experienced previous uncontrolled interruptions of INSTI-based regimens.
4. Patients who have archived DRM conferring a low – or higher - level of resistance to DRV/cobi (>15 points from Stanford dB score) .
5. Patients with unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones)
6. Patients with severe heaptic impairment (class C) according to the Child-Pugh classification
7. Patients with alanine aminotransferase (ALT) = 5 times upper normal limit (ULN) or ALT = 3 times ULN and bilirubin = 1.5 times ULN.
8. Patients with hepatitis C co-infection that would require therapy during the study.
9. Patients with hepatitis B surface antigen (HBsAg) positive.
10. Known allergy to the study drugs or their components.
11. Current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study.
12. Females who are pregnant or breastfeeding.

Study & Design

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