Human Inmunodeficiency Virus Infection (HIV)
Conditions
Interventions
Trade Name: ISENTRESS
Pharmaceutical Form: Coated tablet
INN or Proposed INN: RALTEGRAVIR
CAS Number: 518048-05-0
Concentration unit: mg
Sponsors
FIMABIS Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
APES Costa del Sol (Agencia Pública Empresarial Sanitaria)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement in CNS symptoms at week 12 (DAIDS scale); Secondary Objective: • Interruptions due to adverse effects • Interruptions due to virological failure At week 24: • Presence of CNS symptoms • Intensity of CNS symptoms (visual scale 0 to 10 and DAIDS scale) • Modification of the quality of life (WHOQoL) • Modification in HAD scale • Modification in PSQY scale • Modification in Epworth scale • Modification in CSSR scale To identify, at 24 weeks, patterns of different uptake of the metabolic marker18F-FDG in patients suffering from central nervous system toxicity in relation to the use of Dolutegravir after the substitution to Raltegravir and the anatomical-functional pattern of these patients changes after the replacement of Dolutegravir by Raltegravir ;Primary end point(s): - Neuropsychiatric symptoms (visual scale 0 to 10, DAIDS scale, HAD scale, scale, Epworth scale, PSQY scale and CSSR scale);Timepoint(s) of evaluation of this end point: Week 12 of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Virological failure (detectable viral load) - Questionnaire WHOQoL-bref - Demographic characteristics (sex, age) - Evolution of HIV infection (age of infection, CD4 nadir, risk group) - Current ART and start date - Number of previous treatments - Comorbidities (DM, HBP, dyslipidemia, cancer, liver disease, renal insufficiency, osteopenia-osteoporosis) - Consumption of toxic substances (tobacco (cig./d and packages/year), alcohol (gr/d), use of illicit drugs (type and frequency)) - Use of non-antiretroviral medication (Yes/No and specify which) ;Timepoint(s) of evaluation of this end point: Week 24 of treatment | — |
Countries
Spain
Contacts
Public ContactPlataforma de Estudios Clinicos
FIMABIS
Outcome results
None listed