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Safety, PK and PD Study of ABX464 in Untreated HIV Patients

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ClinicalTrials.gov Identifier: NCT02452242
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
Abivax S.A.

Brief Summary:

ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is intended to assess the safety, the tolerability, and pharmacokinetic parameters and to evaluate the effect on viral load of repeated oral administrations of ABX464 in patients infected by HIV, not previously treated for their HIV.

Two types of design are intended in this protocol: dosing every 3 days or dosing every day. The goal is to determine the best dosing regimen to reduce viral load and minimize adverse events.


Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Infections Drug: ABX464 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Dose Escalation, Schedule Comparison Study to Evaluate the Safety, Pharmacokinetics, and Viral Kinetics of ABX464 in Untreated Patients With HIV Infection in Mauritius
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: ABX464 Drug: ABX464
25, 50, 75, 100, 150 mg, i.e. 1, 2, 3, 4 or 6 capsules respectively, every 3 days or every day for 2 weeks

Placebo Comparator: Placebo Other: Placebo
1, 2, 3, 4 or 6 capsules respectively, every 3 days or every day for 2 weeks




Primary Outcome Measures :
  1. Safety and tolerability profile of ABX464 as assessed by the change from baseline in laboratory values, in vital signs and ECG parameters at week 3 and by the number of patients with adverse events. [ Time Frame: Week 3 ]
    Number of patients with abnormal blood (hematology and biochemistry) and urinary laboratory values, abnormal vital signs and ECG parameters and the number/proportion of patients reporting any adverse event.


Secondary Outcome Measures :
  1. Cmax [ Time Frame: week 1, week 2 and week 3 ]
    Maximum concentration in plasma of ABX464 and metabolite

  2. tmax [ Time Frame: Week 3 ]
    Time to maximum concentration

  3. AUC [ Time Frame: Week 3 ]
    Area under the concentration-time curve

  4. t1/2 [ Time Frame: Week 3 ]
    Half-life of the ABX464 in plasma

  5. Pharmacodynamic activity as expressed by CD4 and CD8 count [ Time Frame: Week 3 ]
    CD4 and CD8 values

  6. Pharmacodynamic activity as expressed by HIV viral load [ Time Frame: Week 3 ]
    HIV viral load across time and possible relationship with PK parameters



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females, 18 to 65 years of age
  2. Patients infected by HIV-1 or HIV-2
  3. BMI between 17 and 29 kg/m².
  4. CD4 cell count ≥ 350 /mm3 and HIV RNA level between 5,000-500,000 copies/mL.
  5. Clinical laboratory tests (hematology, blood chemistry, and urinalyses) must be within normal limits, or clinically acceptable to the sponsor and principal investigator and consistent with the underlying HIV infection.
  6. Urine drug screen for drugs with a high potential for abuse (cocaine, opiates, amphetamines and barbiturates) and alcohol breath test must be negative.
  7. Females must be non lactating and either be of nonchildbearing potential (ie sterilized via hysterectomy or bilateral tubal ligation or at least one year post-menopausal) or if of child bearing potential, must be practicing effective double barrier contraceptive methods from at least two weeks prior to Day 1 until 3 months after the last dose of study medication.
  8. Males must practice an effective barrier method of contraception from Day 1 until 3 months days after the last dose of study medication.
  9. Patients must be willing to give written informed consent prior to study enrollment and be able to adhere to restrictions and examination schedules.
  10. Physical examination and ECG must be within normal limits.
  11. Never taken any antiretroviral agent except for a brief time, and for some reasons, the patient decided not to continue therapy (i.e. Toxicity, personal decision. None in past 30-180 days.

Exclusion Criteria:

  1. Individuals with a history of any significant medical disorders which requires a physician's care.
  2. Individuals who have a history of any clinically significant local or systemic infectious disease (other than HIV-1 or HIV-2 infection) within four weeks prior to drug administration.
  3. Individuals with any clinically significant laboratory abnormalities as defined as grade 2 or 3 in Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
  4. Individuals who are positive for hepatitis B virus and/or hepatitis C virus
  5. Any individual who does not comply with the requirement that he should not have used any drugs (including prescription, nonprescription, herbal, and mineral supplements) other than paracetamol for at least two weeks prior to the study nor alcohol within 48 hours prior to drug administration and for the entire study period. The use of a concomitant medications to treat an AE during the study will not be considered a protocol violation.
  6. Individuals who have participated in a clinical trial of an investigational drug within 90 days prior to the start of the study
  7. Individuals who smoke more than ten cigarettes or equivalent tobacco use per day.
  8. Individuals with forfeiture of freedom by an administrative or legal obligation or under guardianship

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 ClinicalTrials.gov identifier (NCT number): NCT02452242


Locations
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Mauritius
CAP Research Ltd
Curepipe, Mauritius
Thailand
HIV-NAT, Thai Red Cross AIDS Research Center
Bangkok, Thailand, 10330
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Chiang Mai University
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Abivax S.A.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abivax S.A.
ClinicalTrials.gov Identifier: NCT02452242    
Other Study ID Numbers: ABX464-003
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: May 2015
Additional relevant MeSH terms:
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Infection
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Virus Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases