Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection
STERAL
1 other identifier
interventional
45
1 country
10
Brief Summary
Primary Objective: To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among HIV/HCV-coinfected patient. Secondary Trial Objective:
- 1.To compare the proportion of HIV/HCV-coinfected patients with one category decrease in the grade of HS between patients continuing with EFV plus two nucleoside analogs and those switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs.
- 2.To evaluate the proportion of patients who maintain viral control (HIV RNA \< 50 copies/mL) after switching.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2014
Typical duration for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2013
CompletedFirst Posted
Study publicly available on registry
July 16, 2013
CompletedStudy Start
First participant enrolled
February 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2017
CompletedJuly 25, 2017
July 1, 2017
3 years
July 12, 2013
July 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
To compare the impact of switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs versus keeping the same antiretroviral regimen on HS as measured by CAP among HIV/HCV-coinfected patients.
48 weeks
Secondary Outcomes (1)
To evaluate the proportion of patients who maintain viral control (HIV RNA < 50 copies/mL) after switching.
48 weeks
Study Arms (2)
Raltegravir
ACTIVE COMPARATORPatients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.
Efavirenz
ACTIVE COMPARATORPatients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.
Interventions
Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.
Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.
Eligibility Criteria
You may qualify if:
- Each subject must be willing and able to provide written informed consent for the trial.
- Each subject must be ≥ 18 years of age.
- Each subject must be male or non-pregnant, non-breastfeeding female
- Each subject must have diagnosis of HIV infection.
- Each subject must have concomitant coinfection by HCV as shown by detectable plasma HCV RNA.
- Each subject must have stable treatment with EFV plus two nucleoside analogs for ≥24 weeks.
- Each subject must have at least 2 documented plasma HIV RNA \<50 copies/ml during the last 24 weeks, as observed in, at least, two clinical visits.
- Each subject must have HS involving more than 10% of hepatocytes, as determined by a CAP measurement ≥238 dB/m.
- Each sexually active female subject of child-bearing potential must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 3 months after stopping the medication.Medically accepted methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, inert or copper-containing IUD, hormone releasing IUD, systemic hormonal contraceptive, and surgical sterilization (eg,hysterectomy or tubal ligation).Postmenopausal women are not required to use contraception.Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period.
- Each sexually active male subject with a female partner(s) of child-bearing potential must also provide written informed consent to provide information regarding any pregnancy.
- Average daily alcohol intake lower than 50 g for men and 40 g for women.
You may not qualify if:
- The subject has an allergy/sensitivity to investigational product or its/their excipients.
- The female subject is nursing.
- The female subject is pregnant or intending to become pregnant.
- History of ARV failure or documented resistance.
- Baseline resistance to EFV or to any of the nucleoside analogues inhibitors in the regimen.
- The subject has any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
- The subject has active AIDS-defining event (CDC-C) within 24 weeks before screening.
- The subject is candidate for therapy against HCV infection during the 48 week trial period in the opinion of the investigator.
- The subject has a history of malignant neoplasia.
- Active illicit drug use or any other condition that may compromise the study drug adherence in the opinion of the investigators.
- The subject has used any investigational drugs within 30 days of Baseline.
- A subject who has participated in any other clinical trial within 30 days,inclusive, of signing the informed consent form of the current trial.
- The subject or a family member is among the personnel of the investigational or SPONSOR staff directly involved with this trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Juan Macíaslead
Study Sites (10)
Hospital La Línea
La Línea de la Concepción, Cádiz, Spain
H.U. Valme
Seville, Seville, 41014, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Infanta Elena
Huelva, Spain
Complejo Hospitalario de Jaen
Jaén, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Regional Universitario Carlos Haya
Málaga, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Related Publications (1)
Macias J, Mancebo M, Merino D, Tellez F, Montes-Ramirez ML, Pulido F, Rivero-Juarez A, Raffo M, Perez-Perez M, Merchante N, Cotarelo M, Pineda JA; Spanish AIDS Research Network-HEP09 Study Group. Changes in Liver Steatosis After Switching From Efavirenz to Raltegravir Among Human Immunodeficiency Virus-Infected Patients With Nonalcoholic Fatty Liver Disease. Clin Infect Dis. 2017 Sep 15;65(6):1012-1019. doi: 10.1093/cid/cix467.
PMID: 28903510DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan Macías, MD, PhD
Infectious Diseases and Microbiology Unit. Hospital Universitario de Valme. Servicio Andaluz de Salud
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
July 12, 2013
First Posted
July 16, 2013
Study Start
February 3, 2014
Primary Completion
January 17, 2017
Study Completion
January 17, 2017
Last Updated
July 25, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share