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

ABIVAX

Status and phase: Completed; Phase 2

Conditions: Human Immunodeficiency Virus Infections

Treatments: Drug: ABX464; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02452242

ABX464-003

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

ABX464

Experimental group

Treatment:

Drug: ABX464

Placebo

Placebo Comparator group

Treatment:

Other: Placebo