R5 Integrase Study in HIV-1 Naive Patients

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ClinicalTrials.gov Identifier: NCT01204905

Recruitment Status : Completed

First Posted : September 17, 2010

Results First Posted : October 18, 2018

Last Update Posted : May 10, 2021

Sponsor:

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

Human Research Protections Office, University of Maryland, College Park

Study Description

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 7 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

Detailed Description:

Seven antiretroviral naïve HIV infected participants will be treated with a combination of raltegravir and maraviroc and followed for 48 weeks to determine the time to virologic suppression of (HIV-1 viral load < 50 copies/ml).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	7 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Intervention Model Description:	Single arm treatment study
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
Actual Primary Completion Date :	May 16, 2014
Actual Study Completion Date :	May 16, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Maraviroc Raltegravir Raltegravir potassium

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Open Label ART Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.	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

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
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

Locations

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United States, Maryland
University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

University of Maryland, Baltimore

Merck Sharp & Dohme Corp.

Investigators

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Principal Investigator:	Robert R. Redfield, MD	University of Maryland, College Park

More Information

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Responsible Party:	Human Research Protections Office, Associate Director of the Institute of Human Virology, University of Maryland, Baltimore, University of Maryland, College Park
ClinicalTrials.gov Identifier:	NCT01204905
Other Study ID Numbers:	HP-00045769
First Posted:	September 17, 2010 Key Record Dates
Results First Posted:	October 18, 2018
Last Update Posted:	May 10, 2021
Last Verified:	May 2021

Keywords provided by Human Research Protections Office, University of Maryland, College Park:


HIV-1 CD4 Viral Load Human Immunodeficiency Virus (HIV)

Additional relevant MeSH terms:

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HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus 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 HIV Fusion Inhibitors Viral Fusion Protein Inhibitors CCR5 Receptor Antagonists

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