Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1
NCT00993148
ABOUT THIS STUDY
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- 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
- 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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Descriptive Information | ||||
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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 |
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Intervention ICMJE |
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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:
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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Investigators ICMJE |
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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 |