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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 June 2016
• Main ID: NCT02452242
• Date of registration: 10/04/2015
• Prospective Registration: No
• Primary sponsor: Abivax S.A.
• Public title: Safety, PK and PD Study of ABX464 in Untreated HIV Patients
• Scientific 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
• Date of first enrolment: January 2015
• Target sample size: 70
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02452242
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Mauritius, Thailand

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Human Immunodeficiency Virus Infections

Intervention(s)

Other: Placebo

Drug: ABX464

Primary Outcome(s)

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]

Secondary Outcome(s)

AUC [Time Frame: Week 3]

Pharmacodynamic activity as expressed by HIV viral load [Time Frame: Week 3]

t1/2 [Time Frame: Week 3]

Cmax [Time Frame: week 1, week 2 and week 3]

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

tmax [Time Frame: Week 3]

Secondary ID(s)

ABX464-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors