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Open Label, Pilot Study of Darunavir Boosted by Cobicistat in Combination With Rilpivirine to Treat HIV+ Naïve Subjects (PREZENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02404233
Recruitment Status : Unknown
Verified March 2015 by Therapeutic Concepts.
Recruitment status was:  Not yet recruiting
First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Therapeutic Concepts

Brief Summary:
Current HIV treatment guidelines recommend the use of triple-drug therapy (two nucleoside reverse transcriptase inhibitors and either a protease inhibitor, non-nucleoside reverse transcriptase inhibitor, or an integrase inhibitor) for the treatment of antiretroviral (ARV)-naïve patients. With the introduction of highly active antiretroviral therapy (HAART), patients with HIV are living much longer. With the increasing lifespan of persons with HIV, long-term complications from therapy as well as the occurrence of co-morbidities with aging have prompted HCPs to re-think the current treatment paradigm and consider novel combinations of ARVs. All of the currently approved HIV antiretrovirals have been implicated in causing long-term toxicities; however the greatest body of evidence for long-term metabolic effects has implicated the nucleoside reverse transcriptase (NRTI) class. By utilizing a non-NRTI treatment regimen, it is hypothesized that many of these long-term metabolic effects (renal toxicity, bone loss, body fat changes) can be delayed or avoided altogether. The clinical data on novel combinations is currently limited but rapidly growing and has included several combinations that have utilized darunavir. This study will be the first of its kind using the unique combination of darunavir/cobicistat and rilpivirine. Currently, this drug combination is not a recommended option for first time treatment of HIV

Condition or disease Intervention/treatment Phase
HIV Positive Drug: darunavir/cobicistat Drug: rilpivirine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV 48 Week, Open Label, Pilot Study of Darunavir Boosted by Cobicistat in Combination With Rilpivirine to Treat HIV+ Naïve Subjects (PREZENT)
Study Start Date : March 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Darunavir/ cobicistat and Rilpivirine

Single arm study:

Darunavir/ cobicistat 800/ 150 mg tablet once daily taken with food Rilpivirine tablet 25 mg once daily taken with food

Drug: darunavir/cobicistat
Darunavir/ cobicistat 800/ 150 mg tablet once daily taken with food

Drug: rilpivirine
Rilpivirine tablet 25 mg once daily taken with food

Primary Outcome Measures :
  1. Proportion of patients with plasma HIV-1 RNA <50 copies/mL [ Time Frame: up to weeks 48 ]

Secondary Outcome Measures :
  1. Proportion of patients with plasma HIV-1 RNA <400 copies/mL at each time point evaluated [ Time Frame: At week 4, week 12, week 24, week 36, week 48 ]
  2. Number of weeks until HIV RNA <400 copies/mL and <50 copies/mL, respectively [ Time Frame: At week 4, week 12, week 24 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. HIV-1 RNA ≥ 5000 copies/mL by PCR
  2. ≥ 18 years of age
  3. Cognitive ability to understand and provide written informed consent and willingness to participate in and comply with the study protocol
  4. Less than 7 days of prior ART with any licensed or investigational compound
  5. Patient does not currently have or has not been treated for an active opportunistic infection (OI) consistent with CDC definition (Appendix C) within 30 days of screening
  6. Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness
  7. A female is eligible to enter and participate in this study if she is of non child bearing potential or child bearing potential, has a negative serum pregnancy test at screen.

Exclusion Criteria

  1. Patient with active AIDS-defining opportunistic infection or disease according to the 1993 CDC AIDS surveillance definition (Clinical Category C) in the 30 days prior to baseline and that, in the opinion of the investigator, would preclude the patient from participating in the study (See Appendix C).
  2. Patient has none of the following darunavir-associated RAMs: V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V
  3. Having documented genotypic evidence of NNRTI resistance at screening or from historical data available in the source documents, i.e. at least one of the NNRTI rams from the following list; K101E, K101P, E138A, E138G, E138K, E138R, E138Q, , V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I, M230L, or the combination of the K103N and L100I.
  4. History of active substance abuse, excluding cannabis, or psychiatric illness that, in the opinion of the investigator, would preclude compliance with protocol, dosing schedule and assessments.
  5. Patient is either pregnant at time of screening evaluation or breast-feeding.
  6. Patient, in the opinion of the investigator, is unlikely to be able to complete the 48-week dosing period and protocol evaluations and assessments or adhere to the study drug regimen.
  7. Patient suffers from a serious medical condition, such as diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the opinion of the investigator would compromise the safety of the patient
  8. Patient has malabsorption syndrome or other gastrointestinal dysfunction, which may interfere with drug absorption or render the patient unable to take oral medication.
  9. Patient is undergoing interferon therapy for HCV or anticipates undergoing therapy during the course of this trial
  10. HBV co-infection
  11. Patient has any of the following laboratory results within 30 days prior to the first dose of study medication:

    • Hemoglobin concentration < 8.0 g/dL
    • Absolute neutrophil count < 750 cells/mm3
    • Platelet count <50,000 cells/ mm3
    • Aminotransferase (AST, ALT) >3 times ULN
    • Serum creatinine >1.5 times the Upper Limits of Normal (ULN)
  12. Patients with severe hepatic impairment
  13. Patient has required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to entry, or has an anticipated need for these agents within the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02404233

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Contact: Joseph C. Gathe, Jr., MD 713-526-9821
Contact: Bernie A. Miguel, B.S. 713-526-9821

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United States, Texas
Therapeutic Concepts, P.A.
Houston, Texas, United States, 77004
Contact: Joseph C. Gathe, M.D.    713-526-9821   
Contact: Valerie H. Davis, B.S.    713-526-9821   
Principal Investigator: Joseph C. Gathe, M.D.         
Therapeutic Concepts, PA
Houston, Texas, United States, 77004
Sponsors and Collaborators
Therapeutic Concepts
Janssen Scientific Affairs, LLC
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Principal Investigator: Joseph C. Gathe, Jr., MD Therapeutic Concepts, PA
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Responsible Party: Therapeutic Concepts Identifier: NCT02404233    
Other Study ID Numbers: TMC278HIV4003
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors