CHANGES IN LIVER STEATOSIS AFTER SWITCHING TO RALTEGRAVIR IN HIV/HCV COINFECTION

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Andaluz Health Service
Sponsor:
Information provided by (Responsible Party):
Juan Macías, Andaluz Health Service
ClinicalTrials.gov Identifier:
NCT01900015
First received: July 12, 2013
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
HCV Coinfection
HIV Infection
Drug: Raltegravir
Drug: Efavirenz
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Andaluz Health Service:

Primary Outcome Measures:
  • 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. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the proportion of patients who maintain viral control (HIV RNA < 50 copies/mL) after switching. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 96
Study Start Date: November 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Active Comparator: 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.
Drug: Efavirenz

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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, hormonereleasing 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900015

Contacts
Contact: Juan Macías, PhD 955015736 ext 315736 juan.macias.sanchez@gmail.com
Contact: María Mancebo, Nurse 955015871 ext 315871 marmanher86@gmail.com

Locations
Spain
Hospital La Línea Not yet recruiting
La Línea de la Concepción, Cádiz, Spain
Contact: Francisco Téllez       ptellezp@terra.es   
Principal Investigator: Francisco Téllez         
Hospital Universitario Reina Sofía Not yet recruiting
Córdoba, Spain
Contact: Antonio Rivero       ariveror@gmail.com   
Principal Investigator: Antonio Rivero         
Hospital Infanta Elena Not yet recruiting
Huelva, Spain
Contact: Dolores Merino       merinolola080@gmail.com   
Principal Investigator: Dolores merino         
Complejo Hospitalario de Jaen Not yet recruiting
Jaen, Spain
Contact: Mohamed Omar Mohamed-Balghata       omarampa@gmail.com   
Contact: Omar         
Principal Investigator: Mohamed Mohamed-Balghata         
Hospital Universitario 12 de Octubre Not yet recruiting
Madrid, Spain
Contact: Rafael Rubio García       rafaelrubiog@gmail.com   
Principal Investigator: Francisco Pulido Ortega         
Principal Investigator: Rafael Rubio García         
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain
Contact: Juan González       juangonzalezgar@gmail.com   
Principal Investigator: Juan González         
Hospital Universitario Virgen de la Victoria Not yet recruiting
Málaga, Spain
Contact: Manuel Márquez       med000856@gmail.com   
Principal Investigator: Manuel Márquez         
Hospital Regional Universitario Carlos Haya Not yet recruiting
Málaga, Spain
Contact: Marcial Fernández       med006803@gmail.com   
Principal Investigator: Marcial Fernández         
Hospital Universitario Virgen del Rocío Not yet recruiting
Sevilla, Spain
Contact: Luis Fernando López Cortés       lflopez@us.es   
Principal Investigator: Luis Fernando López-Cortés         
H.U. Valme Not yet recruiting
Seville, Spain, 41014
Contact: María Mancebo, Nurse       marmanher86@gmail.com   
Principal Investigator: Juan A Pineda, MD, PhD         
Principal Investigator: Juan Macías, MD,PhD         
Sub-Investigator: Fernando Lozano, MD,PhD         
Sub-Investigator: Ramón Morillo, PhD         
Sponsors and Collaborators
Juan Macías
Investigators
Principal Investigator: Juan Macías, MD, PhD Infectious Diseases and Microbiology Unit. Hospital Universitario de Valme. Servicio Andaluz de Salud
  More Information

No publications provided

Responsible Party: Juan Macías, PhD, Andaluz Health Service
ClinicalTrials.gov Identifier: NCT01900015     History of Changes
Other Study ID Numbers: STERAL/50410
Study First Received: July 12, 2013
Last Updated: July 15, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Ethics Committee
Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Coinfection
Fatty Liver
Hepatitis C
HIV Infections
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Viral, Human
Immune System Diseases
Immunologic Deficiency Syndromes
Infection
Lentivirus Infections
Liver Diseases
Parasitic Diseases
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Efavirenz
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014