R5 Integrase Study in HIV-1 Naive Patients

NCT01204905 | Completed Results DMC

• 1 other identifier: HP-00045769
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Viral Load

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

  48 weeks

Secondary Outcomes (1)

• Viral Suppression

  48 weeks

Study Arms (1)

Open Label ART

EXPERIMENTAL

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

Drug: Raltegravir and Maraviroc in combination

Interventions

Raltegravir and Maraviroc in combination DRUG

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

Also known as: Raltegravir (Isentress), Maraviroc(Selzentry)

Open Label ART

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Maryland, Institute of Human Virology

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Raltegravir Potassium; Maraviroc

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles

Results Point of Contact

• Title: Gregory Brogden
• Organization: University of Maryland, Baltimore, IHV

gbrogden@ihv.umaryland.edu

410-706-1660

Study Officials

• Robert R. Redfield, MD

  University of Maryland, Institute of Human Virology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm treatment study

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Study Start: September 1, 2010
• Primary Completion: May 16, 2014
• Study Completion: May 16, 2014
• Last Updated: November 14, 2022
• Results First Posted: October 18, 2018

Record last verified: 2022-11

Locations

US (1)