Clinical Trials

MainTitle

R5 Integrase Study in HIV-1 Naive Patients

This study has been completed
Sponsor
University of Maryland, College Park

Collaborator
Merck Sharp & Dohme Corp.

Information provided by (Responsible Party)
Human Research Protections Office, University of Maryland, College Park

ClinicalTrials.gov Identifier
NCT01204905

First received: September 16, 2010
Last updated: September 20, 2018
Last Verified: September 2018
History of Changes
Purpose

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 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 Intervention
HIV Infections

Drug : Raltegravir and Maraviroc in combination

Study Type: Interventional
Study Design: 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

Further study details as provided by Human Research Protections Office, University of Maryland, College Park:

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

Enrollment: 7
Study Start Date: September 2010
Study Completion Date: May 16, 2014
Primary Completion Date: May 16, 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name:
  • Raltegravir (Isentress)
  • Maraviroc(Selzentry)

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).

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 75 Years  
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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204905

Locations

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

Sponsors and Collaborators

University of Maryland, College Park
Merck Sharp & Dohme Corp.

Investigators

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

More Information


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   History of Changes  
Other Study ID Numbers: HP-00045769  
Study First Received: September 16, 2010  
Last Updated: September 20, 2018  

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:
HIV Infections
Raltegravir Potassium
Maraviroc

ClinicalTrials.gov processed this data on September 16, 2019
This information is provided by ClinicalTrials.gov.