A Proof of Concept Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of the CCR5 Antagonist TBR 652 in HIV 1-Infected, Antiretroviral Treatment-Experienced, CCR5 Antagonist-Naïve Patients

July 3, 2013 updated by: Tobira Therapeutics, Inc.

A Proof of Concept, Multiple Dose-Escalating Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of the CCR5 Antagonist TBR 652 in HIV 1-Infected, Antiretroviral Treatment-Experienced, CCR5 Antagonist-Naïve Patients

A double-blind, randomized, placebo-controlled, dose-escalating study to assess the antiviral activity, safety, tolerability, and pharmacokinetics (PK) of the CCR5 antagonist TBR 652 monotherapy dosed orally once daily (QD) for 10 days in HIV 1-infected, antiretroviral treatment-experienced, CCR5 antagonist-naïve patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. No clinically significant findings on Screening evaluations (clinical, laboratory, and ECG), which in the opinion of the Investigator would interfere with the subject's ability to comply with the protocol.
  2. Antiretroviral treatment-experienced; no antiretroviral therapy for at least 6 weeks prior to study entry.
  3. CCR5 antagonist therapy naive.
  4. CD4 cell count >/= 250 cells/mm3 during Screening (within 30 days prior to first dose).
  5. Two separate qualifying plasma HIV 1 RNA levels >/= 5,000 copies/mL within 45 days prior to first dose.
  6. Females who are not of reproductive potential (documented to be surgically sterile or postmenopausal [defined as amenorrhea ≥ 1 year and follicle stimulating hormone {FSH} ≥ 30 mU/mL]).
  7. Females of child-bearing potential may be enrolled following a negative serum pregnancy test. If participating in activity that could lead to pregnancy, males and females shall agree to use two forms of barrier method contraception during the trial and for 2 months after stopping the medication.

Exclusion Criteria:

  1. Presence of CXCR4- or dual/mixed-tropic HIV 1 virus.
  2. Active CDC category C disease (except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial).
  3. History of infection with hepatitis B or hepatitis C virus, history of cirrhosis, or any known active or chronic liver disease. NOTE: Hepatitis B vaccinated patients are eligible.
  4. Serum ALT or AST values greater than Grade 1 or bilirubin values greater than the upper limit of normal (ULN) at Screening.
  5. History of HIV-2.
  6. Recent history (< 30 days prior to study drug administration) of clinically significant infection.
  7. Pregnant females or females who are breastfeeding.
  8. Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity within 30 days prior to study drug administration.
  9. Treatment with any vaccine within 30 days of study drug administration.
  10. A positive pre-study drug screen, including amphetamines, barbiturates, cocaine, or PCP.
  11. Anticipated use of antacids during the trial and/or within 7 days prior to first dose of study drug.
  12. Current alcohol or drug use, which in the expert judgment of the investigator, will interfere with the patient's ability to comply with the protocol requirements.
  13. Inability, in the opinion of the investigator, to comply with the dosing schedule and protocol evaluations.
  14. Use of any experimental medications within 4 weeks prior to Screening.
  15. Current (within 30 days prior to the first dose of study drug) or anticipated use of antimetabolites; alkylating agents; or drugs, herbal preparations, and foods (including grapefruit) known to affect the CYP 3A4 or CYP 2C8 enzymes or P-glycoprotein transporters.
  16. History of clinically significant hepatic, metabolic, endocrine, renal, hematologic, pulmonary, gastrointestinal, or cardiovascular disorders (including ECG abnormalities).
  17. Uncontrolled hypertension.
  18. Presence of a malabsorption syndrome affecting drug absorption (e.g., Crohn's disease, chronic pancreatitis).
  19. History of malignancy with exception of cured basal or squamous cell carcinoma of the skin.
  20. Receipt of radiation or cytotoxic chemotherapeutic agents and not recovered from side effects prior to the first dose of study medication.
  21. Subjects who have used any over-the-counter medications (including phytotherapeutic, herbal, or plant-derived preparations) within 14 days prior to the first dose of study medication, unless approved by the Investigator, or who have used St. John's wort within 21 days prior to the first dose of study drug. (St. John's wort is prohibited during the study.)
  22. History or presence of an abnormal ECG.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TBR-652 25 mg QD
TBR 25 mg QD for 10 days
Drug: TBR-652
TBR-652 25 mg
Placebo Comparator: Placebo
Matching Placebo QD for 10 days
Drug: TBR-652 Matching Placebo
Matching Placebo
Experimental: TBR-652 50 mg QD
TBR-652 50 mg QD for 10 days
Drug: TBR-652 50 mg
TBR-652 50 mg QD for 10 days
Experimental: TBR-652 75 mg QD
TBR-652 75 mg QD for 10 days
Drug: TBR-652 75 mg
TBR-652 75 mg QD for 10 days
Experimental: TBR-652 100 mg QD
TBR-652 100 mg QD for 10 days
Drug: TBR-652 100 mg
TBR-652 100 mg QD for 10 days
Experimental: TBR-652 150 mg
TBR-652 150 mg QD for 10 days
Drug: TBR-652 150 mg
TBR-652 150 mg QD for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV-1 RNA Change from Baseline
Time Frame: 10 days
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tobira Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

March 22, 2010

First Submitted That Met QC Criteria

March 22, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 3, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 652-2-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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