Evolution of neurological symptoms after substitution of Dolutegravir for Raltegravir. NEAR QD Study

Phase 1

• Conditions: Human Inmunodeficiency Virus Infection (HIV); Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-003541-17-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: 2018-08-07
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1) = 18 years old
2) HIV-1 infection
3) Receiving antiretroviral treatment whose backbone is ABC / 3TC or TDF / FTC or TAF / FTC, whose third component is DTG in doses of 50 mg / day.
4) Presence of CNS symptoms (any of: insomnia, sleep disturbances, poor concentration, dizziness, headache, depression, restlessness or nervousness) at least intensity 2 on DAIDS
5) Written informed consent to participate into the studyscale.
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1) Breastfeeding, pregnancy or fertile women willing to be pregnant.
2) Concomitant use at baseline of any drug with potential drug-drug interaction with study drugs included in https://www.hiv-druginteractions.org database.
3) Prior documented intolerance, hypersensitivity or resistance to study drugs, or presence of any contraindication to use it.
4) Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry.
5) Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance.
6) Subjects currently taking part in any other clinical trial using an investigational product, with the exception of studies where the treatment studied have stopp ed for more than 12 weeks.
7) AIDS event (CDC Category C) at the diagnosis of HIV infection or in the 3 months before inclusion the study
8) Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
9) Diagnosis of any of the CNS symptoms previously to DTG use.
10) Presence of genotypic mutations that confer resistance to ABC, TDF / TAF, 3TC or FTC
11) Chronic liver disease in the cirrhosis phase (either by ultrasound criteria, or fibroscan = 14.5 KPa)
12) Smoking habit = 20 cigarettes/day.

*For patients included in Hospirtal Costa del Sol de Marbella only (urdergoing PET and MRI scan:
13) History of or suffers from claustrophobia or feels that they will be unable to lie still on their back in the PET or MRI camera for a period of 20 min.
14) Contraindications to MRI, including presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI questionnaire.

Study & Design

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