Treatment naive HIV infected individuals
Conditions
Interventions
Product Name: GTU-MultiHIV B clade
Product Code: GTU-MultiHIV B clade
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intradermal
Sponsors
FIT Biotech Oyj Plc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: Between 18 and 40 years 2. Symptom-free 3. HIV-1 positive, confirmed with WB in Finland and with the established diagnostic testing algorithm in South Africa as outlined in Appendix 3. 4. CD4 lymphocyte counts: ³0.350 x 109/L 5. No previous HAART therapy 6. Negative pregnancy test for women of child bearing potential at each study visit and a clear understanding that reliable contraception troughout the trial must be used. 7. Viral load less than 55 000 copies/ml at the screening visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding 2. Inability to adhere to the study protocol or attend the clinic for the required study visits 3. Persons with a history of immunotherapy < 6 months prior to entry 4. Persons receiving blood transfusion/blood products < 2 months prior to entry 5. Persons who are or need to be vaccinated with other vaccines within 8 weeks prior to or 12 weeks after the first GTU® –MultiHIV vaccination 6. Persons with history of cardiac, liver or renal disease, hypertension with complications or needing treatment with more than one drug, uncontrolled infections or intractable diarrhea 7. Persons with history of AIDS defining illness (disease stage C based on CDC classification) 8. Persons with active chronic viral hepatitis 9. Current use of intravenous drugs 10. Clinically significant abnormalities in the following labaraltory parameters: Creatinine Haemoglobin Leukocytes Platelets Triglycerides 11. Persons on any other investigational drug or vaccine trial 12. No informed consent obtained 13. Known history of kanamycin allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to compare the immunogenicity and clinical efficacy of the trial vaccine with that of placebo;Secondary Objective: Safety and tolerability;Primary end point(s): The cellular immunity mediated by CD8+Tcells as measured by ELISPOT IFN-gamma Humoral immunity by measuring antibodies against HIV-1 proteins | — |
Countries
Finland
Outcome results
None listed