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

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare how safe, tolerable, and effective a novel drug, raltegravir, is to a commonly used combination, atazanavir/ritonavir, as initial treatment in HIV/Hepatitis C co-infected injecting drug users on a methadone program.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. James's Hospital, Ireland
• Treatments: Atazanavir Sulfate; HIV Protease Inhibitors; Methadone; Protease Inhibitors; Raltegravir Potassium; Ritonavir

Criteria

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).