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Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection | Clinical Trials | Clareo Health

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Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection

Changes in Liver Steatosis After Switching From Efavirenz to Raltegravir Among HIV/HCV-Coinfected Patients Receiving Two Nucleoside Analogs Plus Efavirenz: The Steral Study

NCT01900015•Juan Macías

View on ClinicalTrials.gov

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. Design: Open-label, randomized clinical trial to evaluate safety (phase IV) Condition: HIV and HCV coinfection. Intervention: 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.

Detailed Description

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Each subject must be willing and able to provide written informed consent for the trial.
•2. Each subject must be ≥ 18 years of age.
•3. Each subject must be male or non-pregnant, non-breastfeeding female
•4. Each subject must have diagnosis of HIV infection.
•5. Each subject must have concomitant coinfection by HCV as shown by detectable plasma HCV RNA.
•6. Each subject must have stable treatment with EFV plus two nucleoside analogs for ≥24 weeks.
•7. 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.
•8. Each subject must have HS involving more than 10% of hepatocytes, as determined by a CAP measurement ≥238 dB/m.
•9. 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.
•10. 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.
+1 more criteria

Exclusion Criteria

•1. The subject has an allergy/sensitivity to investigational product or its/their excipients.
•2. The female subject is nursing.
•3. The female subject is pregnant or intending to become pregnant.
•4. History of ARV failure or documented resistance.
•5. Baseline resistance to EFV or to any of the nucleoside analogues inhibitors in the regimen.
•6. 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.
•7. The subject has active AIDS-defining event (CDC-C) within 24 weeks before screening.
•8. The subject is candidate for therapy against HCV infection during the 48 week trial period in the opinion of the investigator.
•9. The subject has a history of malignant neoplasia.
•10. Active illicit drug use or any other condition that may compromise the study drug adherence in the opinion of the investigators.
+3 more criteria

Locations (10)

Hospital La Línea

La Línea de la Concepción, Cádiz, Spain

H.U. Valme

Seville, Seville, 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

Key Dates

Start Date

February 3, 2014

Primary Completion Date

January 17, 2017

Completion Date

January 17, 2017

Last Updated

July 25, 2017

Enrollment

ACTUAL participants

Conditions

HCV CoinfectionHIV Infection

Interventions

Raltegravir

DRUG

Efavirenz

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection

Inclusion Criteria

Exclusion Criteria

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