Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1

NCT00993148

Last updated date
Study Location
Quest Clinical Research
San Francisco, California, , United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV-1 Infection, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- HIV-1 infection, as documented by any licensed HIV test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA any time prior to study entry

- Plasma HIV-1 RNA 5, 000 to 500,000 copies/mL obtained within 90 days prior to study entry

- Exclusive R5 tropism based on enhanced sensitivity Trofile assay done within 90 days prior to entry

- CD4 cell count > 100 cells/mm3 within 90 days prior to study entry

- HIV genotype (for RT and protease) performed at any time before study entry (Subjects with single or combination NNRTI or NRTI RAM(s) at screening are permitted)

- ARV drug-naïve, defined as no previous ARV treatment at any time prior to study entry

- Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry

- Negative result from a hepatitis C antibody test performed within 90 days prior to study entry

- Laboratory values obtained within 30 days prior to study entry:

- ANC >=750/mm3

- Hemoglobin >=10 g/dL

- Platelets >=50,000/mm3

- AST (SGOT), ALT (SGPT), and alkaline phosphatase <=5 x ULN

- Calculated creatinine clearance (CrCl) >=30 mL/min, as estimated by the Cockcroft-Gault equation*

- Negative serum or urine pregnancy test within 48 hours prior to study entry for women with reproductive potential

- If participating in sexual activity that could lead to pregnancy, the study subjects with reproductive potential must use one form of contraceptive while receiving protocol-specified medications and for 60 days after stopping the medications.

- Men and women age >=18 years

- Ability and willingness of subject or legal guardian/representative to provide informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Serious illness requiring systemic treatment and/or hospitalization until candidate
either completes therapy or is clinically stable on therapy, in the opinion of the
site investigator, for at least 7 days prior to study entry


- Screening HIV genotype obtained any time prior to study entry with any DRV RAM (V11I,
V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V)


- Treatment within 30 days prior to study entry with immune modulators such as systemic
steroids, interleukins, interferons, granulocyte colony-stimulating factor (G-CSF),
erythropoietin, or any investigational therapy. NOTE: Subjects receiving stable
physiologic glucocorticoid doses (defined as prednisone ≤10 mg/day [or equivalent] as
a stable or tapering dose) are permitted. Subjects receiving corticosteroids for acute
therapy for PCP or asthma exacerbation, or receiving a short course (defined as ≤2
weeks of pharmacologic glucocorticoid therapy) are permitted


- Breast-feeding


- Requirement for any medication that is prohibited with a study medication


- Known allergy/sensitivity to study drugs or their formulations. A history of sulfa
allergy is not an exclusion


- Active drug or alcohol use or dependence that could interfere with adherence to study
requirements

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HIV-1 Infection, HIV InfectionsMaraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1
NCT00993148
  1. San Francisco, California
  2. Miami, Florida
  3. Chicago, Illinois
  4. Chicago, Illinois
  5. Omaha, Nebraska
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1
Official Title  ICMJE Maraviroc Plus Darunavir/Ritonavir Study for Treatment-Naïve Patients Infected With R5-tropic HIV-1 Based on Enhanced Sensitivity Trofile
Brief Summary The objective of this study is to evaluate the safety and efficacy of a novel combination antiretroviral therapy regimen consisting of maraviroc plus darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1. The hypothesis is that in treatment-naive subjects infected with R5-tropic HIV-1, combination antiretroviral therapy with maraviroc plus darunavir/ritonavir is well tolerated and efficacious.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV-1 Infection
  • HIV Infections
Intervention  ICMJE
  • Drug: maraviroc
    150 mg tab by mouth once daily for 96 weeks
    Other Name: Selzentry
  • Drug: darunavir
    800 mg tab by mouth once daily for 96 weeks
    Other Name: Prezista
  • Drug: ritonavir
    100 mg capsule by mouth once daily for 96 weeks
    Other Name: norvir
Study Arms  ICMJE Experimental: Maraviroc plus darunavir/ritonavir
Single arm open label trial of maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily for 96 weeks
Interventions:
  • Drug: maraviroc
  • Drug: darunavir
  • Drug: ritonavir
Publications * Taiwo B, Acosta EP, Ryscavage P, Berzins B, Lu D, Lalezari J, Castro J, Adeyemi O, Kuritzkes DR, Eron JJ, Tsibris A, Swindells S. Virologic response, early HIV-1 decay, and maraviroc pharmacokinetics with the nucleos(t)ide-free regimen of maraviroc plus darunavir/ritonavir in a pilot study. J Acquir Immune Defic Syndr. 2013 Oct 1;64(2):167-73. doi: 10.1097/QAI.0b013e3182a03d95.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2009)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV-1 infection, as documented by any licensed HIV test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA any time prior to study entry
  • Plasma HIV-1 RNA 5, 000 to 500,000 copies/mL obtained within 90 days prior to study entry
  • Exclusive R5 tropism based on enhanced sensitivity Trofile assay done within 90 days prior to entry
  • CD4 cell count > 100 cells/mm3 within 90 days prior to study entry
  • HIV genotype (for RT and protease) performed at any time before study entry (Subjects with single or combination NNRTI or NRTI RAM(s) at screening are permitted)
  • ARV drug-naïve, defined as no previous ARV treatment at any time prior to study entry
  • Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry
  • Negative result from a hepatitis C antibody test performed within 90 days prior to study entry
  • Laboratory values obtained within 30 days prior to study entry:

    • ANC >=750/mm3
    • Hemoglobin >=10 g/dL
    • Platelets >=50,000/mm3
    • AST (SGOT), ALT (SGPT), and alkaline phosphatase <=5 x ULN
    • Calculated creatinine clearance (CrCl) >=30 mL/min, as estimated by the Cockcroft-Gault equation*
  • Negative serum or urine pregnancy test within 48 hours prior to study entry for women with reproductive potential
  • If participating in sexual activity that could lead to pregnancy, the study subjects with reproductive potential must use one form of contraceptive while receiving protocol-specified medications and for 60 days after stopping the medications.
  • Men and women age >=18 years
  • Ability and willingness of subject or legal guardian/representative to provide informed consent

Exclusion Criteria:

  • Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry
  • Screening HIV genotype obtained any time prior to study entry with any DRV RAM (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V)
  • Treatment within 30 days prior to study entry with immune modulators such as systemic steroids, interleukins, interferons, granulocyte colony-stimulating factor (G-CSF), erythropoietin, or any investigational therapy. NOTE: Subjects receiving stable physiologic glucocorticoid doses (defined as prednisone ?10 mg/day [or equivalent] as a stable or tapering dose) are permitted. Subjects receiving corticosteroids for acute therapy for PCP or asthma exacerbation, or receiving a short course (defined as ?2 weeks of pharmacologic glucocorticoid therapy) are permitted
  • Breast-feeding
  • Requirement for any medication that is prohibited with a study medication
  • Known allergy/sensitivity to study drugs or their formulations. A history of sulfa allergy is not an exclusion
  • Active drug or alcohol use or dependence that could interfere with adherence to study requirements
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00993148
Other Study ID Numbers  ICMJE MIDAS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Babafemi Taiwo, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE
  • Pfizer
  • Tibotec, Inc
Investigators  ICMJE
Principal Investigator:Babafemi Taiwo, MDNorthwestern University
PRS Account Northwestern University
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP