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

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.