Safety, Tolerability and Immunogenicity Induced by the THV01 Treatment in Patients Infected With HIV-1 Clade B and Treated With Highly Active Antiretroviral Therapy (HAART).

This is an interventional treatment trial for HIV Infection Read More

Inclusion criteria

• Patients infected with clade B HIV-1;
• Confirmation of a Gag clade B genotyping performed at screening;
• Patient must be treated by a triple agents therapy for more than 12 months at baseline: this triple agents therapy should encompasses two (2) nucleosidic reverse transcriptase inhibitors plus one (1) boosted protease inhibitor, or two (2) nucleosidic reverse transcriptase inhibitors plus one (1) non nucleosidic reverse transcriptase inhibitor;
• Patients must be treated for more than 60 days at baseline by two (2) nucleosidic reverse transcriptase inhibitors plus a ritonavir boosted protease inhibitor treatment among darunavir+ritonavir or lopinavir+ritonavir;
• Patients' HIV plasma viral load ≤150,000 copies mL-1 at any monitoring time (apart measurement during primo-infection if recorded);
• Patients with HIV plasma viral load persistently ≤ 50 copies mL-1 during the 12 months prior to screening;
• Patients' CD4+ T cells count ≥ 300 cells per mm3 at any time since diagnosis;
• Patient's CD4+ T cells count < 500 cells per mm3 at least once from diagnosis to initiation of antiretroviral treatment;
• Patients with CD4+ T cells count ≥ 600 cells per mm3 at baseline;
• Man or woman aged 18-55 years;

Exclusion Criteria

• HIV-2 infection;
• Patient treated by HIV entry of fusion inhibitors;
• Patient treated by HIV integrase inhibitors;
• Patient displaying any HIV protease inhibitor resistance mutation as listed in the current version of the HIV drug resistance database (Stanford University);
• Patient having undergone virological failure as defined by a viral load ≥ 500 copies mL-1 confirmed by a second measure, since initiation of treatment;
• More than 2 blips with viral load comprised between 50 and 500 copies mL-1 during the 12 months prior inclusion;
• History of an AIDS-defining clinical illness;
• Concomitant AIDS-related opportunistic disease;
• History of allergic disease, anaphylaxis or reactions likely to be triggered or exacerbated by any component of the vaccine such as lactose;
• Acute or chronic infectious disease other than AIDS (include but not limited to viral hepatitis such as hepatitis B and hepatitis C, active tuberculosis, active syphilis, HTLV-1, HTLV-2);
• Acute, chronic or history of clinically relevant pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable CNS pathology, angina or cardiac arrhythmias, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history;
• Severe hepatic impairment;
• Serious dyslipidaemia;
• Severe disorders of blood coagulation;
• Known or suspected allergy to egg phospholipids, soy proteins and/or peanut;
• Acute, chronic or history of immunodeficiency or autoimmune disease other than HIV infection;
• Unstable asthma (defined as sudden acute attacks occurring in less than three hours without an obvious trigger, hospitalisation for asthma in the last two years); food or wine induced asthma;
• History of malignancy unless there has been surgical excision that is considered to have achieved cure;
• Active malignancy that may require chemotherapy or radiation therapy;
• Seizure disorder or any history of prior seizure;
• Subjects planning to receive a prophylactic or therapeutic vaccination during the study except Influenza immunization;
• Subjects who have received any vaccination for the 3 months prior the first injection;
• Subjects having an infective exacerbation as defined as a requirement of inhaled, oral, or intravenous antibiotics at W-2 or later;
• Serious illness requiring systemic treatment and/or hospitalization within 7 days prior to baseline;
• Pregnant or breast-feeding woman;
• Any contraindication of intramuscular injection;
• Active drug or alcohol abuse or dependence;
• Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol.