R5 Integrase Study in HIV-1 Naive Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified November 2012 by Robert Redfield, MD, University of Maryland.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01204905

First Posted: September 17, 2010

Last Update Posted: November 9, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

Robert Redfield, MD, University of Maryland

Purpose

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	Intervention
HIV Infections	Drug: Raltegravir and Maraviroc in combination


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Maraviroc Raltegravir Raltegravir potassium

U.S. FDA Resources

Further study details as provided by Robert Redfield, MD, University of Maryland:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Viral Suppression [ Time Frame: 48 months ]
Time to attainment of virologic suppression


Estimated Enrollment:	10
Study Start Date:	September 2010
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility

Information from the National Library of Medicine

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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

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


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 Submitted:	September 16, 2010
First Posted:	September 17, 2010
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

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