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R5 Integrase Study in HIV-1 Naive Patients

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ClinicalTrials.gov Identifier: NCT01204905
Recruitment Status : Unknown
Verified November 2012 by Robert Redfield, MD, University of Maryland.
Recruitment status was:  Recruiting
First Posted : September 17, 2010
Last Update Posted : November 9, 2012
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Robert Redfield, MD, University of Maryland

Study Description
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Brief Summary:

This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients. The study will enroll 10 antiretroviral naïve patients with CD4 counts ≥ 350 and viral loads > 5,000. The subjects will be followed for 48 weeks. The combination of these two agents has the potential to be a potent regimen with minimal metabolic complications. However, they have not been studied in combination previously.

This pilot study proposes to evaluate this combination in antiretroviral naïve patients to document the safety and efficacy of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications.


Condition or disease Intervention/treatment Phase
HIV Infections Drug: Raltegravir and Maraviroc in combination Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Raltegravir and Maraviroc in Combination for the Treatment of Antiretroviral Naïve HIV-1 Infected Patients
Study Start Date : September 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Open Label Drug: Raltegravir and Maraviroc in combination

Raltegravir 400 mg tablet twice a day, ~12 hours (10 to 14 hours) apart

Maraviroc 300 mg tablet twice a day, ~12 hours (10 to 14 hours) apart

Other Names:
  • Raltegravir (Isentress)
  • Maraviroc(Selzentry)


Outcome Measures
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Primary Outcome Measures :
  1. Viral Load [ Time Frame: 48 months ]
    Percentage of subjects with HIV-1 viral load < 50 copies/ml


Secondary Outcome Measures :
  1. Viral Suppression [ Time Frame: 48 months ]
    Time to attainment of virologic suppression


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-1 infection
  • CD4 count ≥ 350
  • RNA > 5,000
  • CCR5 tropic virus
  • Baseline genotype without significant mutations known to confer antiretroviral drug resistance to currently licensed antiretroviral agents
  • Antiretroviral naïve (< 7 days of experience)
  • 18-75 years of age
  • Subject able to provide informed consent for the study
  • Women of child-bearing age agree to remain abstinent or use (or have their partner use) an acceptable method of birth control throughout the study. Acceptable method of birth control is defined as intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy.

Exclusion Criteria:

  • Dual/mixed tropic virus,
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limits of normal;
  • Total bilirubin >1.5 mg/dL,
  • Women pregnant or breastfeeding,
  • History of malignancy
  • Enrollment in an experimental protocol with concomitant use of drugs known to impact or be impacted in terms of pk or drug-drug interactions with either raltegravir or maraviroc. This includes inducers of UGT1A1 ( such as rifampin, phenytoin, Phenobarbital rifabutin, St. John's wart) as well as CYP3A inhibitors (such as ketoconazole, itraconazole, clarithromycin , nefazodone and telithromycin) and CYP3A inducers (such as rifampin, carbamazepine, Phenobarbital and phenytoin)
  • Enrollment in an experimental protocol having received investigational agents(antiretroviral or non-antiretroviral) within 30 days of study enrollment
  • Chronic active hepatitis B infection
  • Subject has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
  • Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
  • Subject requires or is anticipated to require any of the prohibited medications noted in the protocol
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT01204905


Contacts
Contact: Colleen Boyce, RN 410-706-0100

Locations
United States, Maryland
University of Maryland, Institute of Human Virology Recruiting
Baltimore, Maryland, United States, 21201
Contact: Colleen Boyce, RN    410-706-0100      
Principal Investigator: Robert Redfield, MD         
Sponsors and Collaborators
University of Maryland
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Robert R. Redfield, MD University of Maryland
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Robert Redfield, MD, Associate Director of the Institute of Human Virology, University of Maryland, Baltimore, University of Maryland
ClinicalTrials.gov Identifier: NCT01204905     History of Changes
Other Study ID Numbers: HP-00045769
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012

Keywords provided by Robert Redfield, MD, University of Maryland:
HIV-1
CD4
Viral Load
Human Immunodeficiency Virus (HIV)

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
 Maraviroc
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
CCR5 Receptor Antagonists