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

NCT02404233 | Unknown Phase 4

• 1 other identifier: TMC278HIV4003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

HIV Positive

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with plasma HIV-1 RNA <50 copies/mL

  up to weeks 48

Secondary Outcomes (2)

• Proportion of patients with plasma HIV-1 RNA <400 copies/mL at each time point evaluated

  At week 4, week 12, week 24, week 36, week 48

• Number of weeks until HIV RNA <400 copies/mL and <50 copies/mL, respectively

  At week 4, week 12, week 24

Study Arms (1)

Darunavir/ cobicistat and Rilpivirine

EXPERIMENTAL

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; Drug: rilpivirine

Interventions

darunavir/cobicistat DRUG

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

Also known as: PREZCOBIX™ ; EDURANT®

Darunavir/ cobicistat and Rilpivirine

rilpivirine DRUG

Rilpivirine tablet 25 mg once daily taken with food

Darunavir/ cobicistat and Rilpivirine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 RNA ≥ 5000 copies/mL by PCR
• ≥ 18 years of age
• Cognitive ability to understand and provide written informed consent and willingness to participate in and comply with the study protocol
• Less than 7 days of prior ART with any licensed or investigational compound
• 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
• Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness
• 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.

You may not qualify if:

• 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).
• Patient has none of the following darunavir-associated RAMs: V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V
• 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.
• 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.
• Patient is either pregnant at time of screening evaluation or breast-feeding.
• 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.
• 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
• Patient has malabsorption syndrome or other gastrointestinal dysfunction, which may interfere with drug absorption or render the patient unable to take oral medication.
• Patient is undergoing interferon therapy for HCV or anticipates undergoing therapy during the course of this trial
• HBV co-infection
• 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

Sponsors & Collaborators

• Therapeutic Concepts: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (2)

Therapeutic Concepts, P.A.

Houston, Texas, 77004, United States

Location

Therapeutic Concepts, PA

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

HIV Seropositivity

Interventions

cobicistat mixture with darunavir; Rilpivirine

Condition Hierarchy (Ancestors)

HIV Infections; 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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Joseph C. Gathe, Jr., MD

  Therapeutic Concepts, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph C. Gathe, Jr., MD

CONTACT

713-526-9821; drgathe@josephgathe.com

Bernie A. Miguel, B.S.

CONTACT

713-526-9821; bmiguel@josephgathe.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: March 31, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

US (2)