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R5 Integrase Study in HIV-1 Naive Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Raltegravir and Maraviroc in combination
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, CD4, Viral Load, Human Immunodeficiency Virus (HIV)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Maryland, Institute of Human Virology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label ART

Arm Description

Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.

Outcomes

Primary Outcome Measures

Viral Load
Percentage of subjects with HIV-1 viral load < 50 copies/ml

Secondary Outcome Measures

Viral Suppression
Time to attainment of virologic suppression

Full Information

First Posted
September 16, 2010
Last Updated
November 9, 2022
Sponsor
University of Maryland, Baltimore
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01204905
Brief Title
R5 Integrase Study in HIV-1 Naive Patients
Official Title
Raltegravir and Maraviroc in Combination for the Treatment of Antiretroviral Naïve HIV-1 Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 16, 2014 (Actual)
Study Completion Date
May 16, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, CD4, Viral Load, Human Immunodeficiency Virus (HIV)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm treatment study
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label ART
Arm Type
Experimental
Arm Description
Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Raltegravir and Maraviroc in combination
Other Intervention Name(s)
Raltegravir (Isentress), Maraviroc(Selzentry)
Intervention Description
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
Primary Outcome Measure Information:
Title
Viral Load
Description
Percentage of subjects with HIV-1 viral load < 50 copies/ml
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Viral Suppression
Description
Time to attainment of virologic suppression
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert R. Redfield, MD
Organizational Affiliation
University of Maryland, Institute of Human Virology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, Institute of Human Virology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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R5 Integrase Study in HIV-1 Naive Patients

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