Safety and Efficacy Study Comparing Raltegravir to a Protease Inhibitor in Treatment-naïve, HIV/Hepatitis C Drug Users

U.S. FDA Resources

Estimated Enrollment:	40
Study Start Date:	August 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

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Inclusion Criteria:

• Male or Female Patients Age ≥ 18 years old.
• Naïve to antiretroviral treatment.
• Subject must be willing and able to understand and provide written, informed consent prior to participation in the study.
• Subjects must be on concurrent methadone maintenance therapy.
• Documented HIV infection (antibody positive).
• Documented Hepatitis C co-infection (PCR positive).
• HIV RNA > 5,000.
• Indication for starting ART according to guidelines.
• Documented resistance profile taken at baseline and includes investigational medicinal products.

• Females may be eligible for enrolment in the study if she is of:

  1. Non-childbearing potential; or, Child-bearing potential females must have a negative pregnancy test at initial screening and agree to an acceptable barrier and/or hormonal method of contraception; Sterilization

Exclusion Criteria:

• Subject is in the initial acute phase of a CDC Clinical Category C infection at Baseline. Subjects may be enrolled provided they are receiving treatment for such infections and are clinically improving at the Baseline visit.
• Concurrent treatment with an investigational drug or participation in another clinical trial.
• Use of an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of investigational medicinal product.
• Subject is, in the opinion of the investigator, unable to complete the study dosing period and protocol evaluations and assessments.
• Subject has evidence of genotypic (as defined by the current ANRS AC-11 algorithm) resistance to raltegravir, atazanavir and ritonavir at screening.
• Patients with alcohol and drug use problems that in the view of investigator will compromise participation in the study.
• Elevated alanine aminotransferase (ALT) > 5 times upper limit of normal (ULN)
• Subjects with severe hepatic impairment (Child-Pugh score > 9).
• Subjects receiving treatment for HCV.
• Subjects with concurrent HBV infection.
• Subject is pregnant or breast feeding.
• Subject suffers from any serious medical condition which would compromise the safety of the subject.
• Subject has a pre-existing mental, physical, or substance abuse disorder that may interfere with the subject's ability to comply with the dosing schedule and protocol evaluations and assessments.
• Subject has a condition or disorder which may interfere with drug absorption or render the subject unable to take oral medication.
• Subject has any acute laboratory abnormality at screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound. Any verified Grade 4 laboratory abnormality would exclude a subject from study participation.
• Subject has an estimated creatinine clearance < 50 mL/min via the Cockcroft-Gault method [Cockcroft, 1976].
• Subject is receiving, or has received within 14 days prior to screen, any drug that has been classified as 'contraindicated' from use with RAL or ATV/RTV.
• Subject has received treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to Screening, or has an anticipated need for these agents within the study period.
• Subject has received treatment with an HIV-1 immunotherapeutic vaccine or any agents with documented activity against HIV-1 in vitro within 28 days prior to screening, or an anticipated need during the study.
• Subjects who require treatment with any contraindicated medications within 14 days of commencement of investigational medicinal product, or an anticipated need during the study.
• Subject has a history of allergy to any of the investigational medicinal products or any excipients therein.
• Subject has prolonged QTc interval on screening electrocardiogram (repeated demonstration of a QTc interval >450ms in men and >470ms in women).

St. James's Hospital, Ireland

HIV Hepatitis C Co-infection

Intravenous drug users Treatment-naïve Methadone

HIV Infections Acquired Immunodeficiency Syndrome Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Antitussive Agents Respiratory System Agents HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Hepatitis Hepatitis A

Hepatitis C Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections