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

HIV Infection Clinical Trial

— STERAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900015
• Other study ID #: STERAL/50410
• Status: Completed
• Phase: Phase 4
• First received: July 12, 2013
• Last updated: July 24, 2017
• Start date: February 3, 2014
• Est. completion date: January 17, 2017

Study information

• Verified date: July 2017
• Source: Andaluz Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Study population and sample size HIV-infected patients with concomitant coinfection by HCV, as shown by detectable plasma HCV RNA, not candidates for therapy against HCV infection during the 48 week period of the Number of patients to recruit: 96, 48 patients per treatment group should be recruited.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 17, 2017
• Est. primary completion date: January 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

11. Average daily alcohol intake lower than 50 g for men and 40 g for women.

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.

11. The subject has used any investigational drugs within 30 days of Baseline.

12. A subject who has participated in any other clinical trial within 30 days,inclusive, of signing the informed consent form of the current trial.

13. The subject or a family member is among the personnel of the investigational or SPONSOR staff directly involved with this trial.

Related Conditions & MeSH terms

• Coinfection
• Fatty Liver
• HCV Coinfection
• Hepatitis C
• HIV Infection
• HIV Infections

Intervention

Drug:
• Raltegravir
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.
• Efavirenz
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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Infanta Elena	Huelva
Spain	Complejo Hospitalario de Jaen	Jaen
Spain	Hospital La Línea	La Línea de la Concepción	Cádiz
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	Sevilla
Spain	H.U. Valme	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Juan Macías

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the proportion of patients who maintain viral control (HIV RNA < 50 copies/mL) after switching.		48 weeks

External Links

•   Abstract presented at CROI 2017. Poster available to download
•   CROI webcast. THEMED DISCUSSION: OBESITY AND FATTY LIVER DISEASE