Safety and Efficacy Study Comparing Raltegravir to a Protease Inhibitor in Treatment-naïve, HIV/Hepatitis C Drug Users
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ClinicalTrials.gov Identifier: NCT01105611 |
Recruitment Status
: Unknown
Verified March 2010 by St. James's Hospital, Ireland.
Recruitment status was: Recruiting
First Posted
: April 16, 2010
Last Update Posted
: July 21, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Hepatitis C | Drug: Raltegravir Drug: Atazanavir/Ritonavir | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label, Randomised Pilot Study Comparing the Efficacy, Safety and Tolerability of Raltegravir With Protease Inhibitor-based Therapy in Treatment-naïve, HIV/Hepatitis C Co-infected Injecting Drug Users Receiving Methadone |
Study Start Date : | August 2010 |
Estimated Primary Completion Date : | December 2012 |
Estimated Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Raltegravir
Raltegravir in combination with Tenofovir/Emtricitabine
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Drug: Raltegravir
400mg orally twice daily. Number of cycles: unless toxicity or treatment failure occurs, there will be no anticipated treatment discontinuation.
Other Name: Isentress™
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Active Comparator: Atazanavir/Ritonavir
Atazanavir 300mg orally once daily with Ritonavir 100mg orally once daily; together with combination of Tenofovir/Emtricitabine
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Drug: Atazanavir/Ritonavir
Atazanavir 300mg orally once daily boosted with Ritonavir orally 100mg once daily. Number of cycles: unless toxicity or treatment failure occurs, there will be no anticipated treatment discontinuation.
Other Name: Reyataz™ (Atazanavir), Norvir™ (Ritonavir)
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- Incidence of grade 3-4 liver function test (LFT) elevations [ Time Frame: 4 weeks ]
- Incidence of grade 3-4 liver function test (LFT) elevations [ Time Frame: 12 weeks ]
- Incidence of grade 3-4 liver function test (LFT) elevations [ Time Frame: 24 weeks ]
- Incidence of grade 3-4 liver function test (LFT) elevations [ Time Frame: 36 weeks ]
- Incidence of grade 3-4 liver function test (LFT) elevations [ Time Frame: 48 weeks ]
- Incidence of grade 3-4 liver function test (LFT) elevations [ Time Frame: 60 weeks ]
- Incidence of grade 3-4 liver function test (LFT) elevations [ Time Frame: 72 weeks ]
- Incidence of grade 3-4 liver function test (LFT) elevations [ Time Frame: 84 weeks ]
- Incidence of grade 3-4 liver function test (LFT) elevations [ Time Frame: 96 weeks ]
- Viral suppression [ Time Frame: 24 weeks ]Viral suppression is defined as HIV-1 RNA less than 50 copies per mL
- Viral suppression [ Time Frame: 48 weeks ]Viral suppression is defined as HIV- RNA less than 50 copies per mL.
- Immunologic response [ Time Frame: 96 weeks ]Recovery of CD4 count
- Overall safety in patients with mild to moderate hepatic impairment [ Time Frame: 48 weeks ]
- Outpatient retention rates [ Time Frame: 96 weeks ]
- QTc interval changes [ Time Frame: 4 weeks ]Effects of pharmacological intervention on corrected QT interval on electrocardiogram
- Immunologic response [ Time Frame: 24 weeks ]
- Immunologic response [ Time Frame: 48 weeks ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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Females may be eligible for enrolment in the study if she is of:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105611
Contact: Colm Bergin, MD, FRCPI | +35314162507 | cbergin@stjames.ie | |
Contact: James Woo, MB, MRCPI | +353868108086 | wooj@tcd.ie |
Ireland | |
Department of Genitourinary Medicine and Infectious Diseases, St. James's Hospital | Recruiting |
Dublin, Ireland | |
Contact: Colm Bergin, MD, FRCPI +35314162507 cbergin@stjames.ie | |
Contact: James Woo, MB, MRCPI +353868108086 wooj@tcd.ie | |
Principal Investigator: Colm Bergin, MD, FRCPI | |
Sub-Investigator: James Woo, MB, MRCPI | |
Mater Misericordiae University Hospital | Not yet recruiting |
Dublin, Ireland | |
Contact: Patrick Mallon, MB FRCPI PhD +35317166311 Paddy.Mallon@ucd.ie | |
Principal Investigator: Patrick Mallon, MB FRCPI PhD |
Principal Investigator: | Colm Bergin, MD, FRCPI | Department of Genitourinary Medicine and Infectious Diseases, St. James's Hospital, Dublin, Ireland |
Publications:
Responsible Party: | Professor Colm Bergin, St. James's Hospital, Dublin, Ireland |
ClinicalTrials.gov Identifier: | NCT01105611 History of Changes |
Other Study ID Numbers: |
CB-2010-01 2010-018326-39 ( EudraCT Number ) |
First Posted: | April 16, 2010 Key Record Dates |
Last Update Posted: | July 21, 2011 |
Last Verified: | March 2010 |
Keywords provided by St. James's Hospital, Ireland:
HIV Hepatitis C Co-infection |
Intravenous drug users Treatment-naïve Methadone |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis C HIV Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Atazanavir Sulfate HIV Protease Inhibitors Raltegravir Potassium Protease Inhibitors Methadone Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |