HIV positive subjects who have been clinically stable on antiretroviral therapy for the last six months with a viral load less than 50 copies/mL for the last six months and a CD4 cell count => 400 x 10^6/L and who meet the other inclusion and exclusion criteria of the protocol MedDRA version: 12.0 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Sponsors
Bionor Immuno AS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 55 years 2. HIV positive at least one year 3. Clinical stable on antiretroviral therapy for the last six months 4. Documented viral load less than 50 copies/mL for the last six months 5. Documented prestudy CD4 cell count => 400 x 10^6/L 6. Nadir (lowest ever) CD4 cell count => 200 x 10^6/L 7. Signed informed consent 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Reported pre-study AIDS defining illness within the previous year (see Appendix 15.3 of protocol) 2. Malignant disease 3. On chronic treatment with immune suppressive therapy 4. Unacceptable values of the haematologic and clinical chemistry parameters, as judged by the Investigator or the Sponsor (or designee) including creatinine values > 1.5 x upper limit of norma and asparatate aminotransferase (SGOT), alanine aminotransferase (SGOT) and alkaline phosphatase values greater than 2.5 x upper limit of normal 5. Concurrent chronic active infection such as chronic viral hepatitis B or C or active tuberculosis 6. Pregnant or breast feeding women 7. Women of childbearning potential not using reliable and adequate contraceptive methods (defined as: use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; practicing abstinence or sterile) during the 18 week treatment period and for 2 weeks after the last immunization, or sexually active male patients with partners of child bearing potential unwilling to practice effective contraception during the 18 week treatment period and for 12 weeks after the last immunization. 8. Concurrent participation in other clinical therapeutic studies 9. Incapability of compliance to the treatment protocol, in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of Vacc-4x immunizations versus placebo on CD4 counts, T-cell function (ELISPOT, T-cell proliferative responses and intracellular cytokine staining), and the response to interruption of antiretroviral therapy (changes in CD4 counts, rate of CD4 decline, viral load, and the proportion of subjects restarting antiretroviral therapy because of a decrease in CD4 counts to less than 350 x 10^6/L, or by =>50% of the count at the antiretroviral free period start, or viral load increases above 300, 000 copies/mL within 24 weeks after stopping antiretroviral therapy;Secondary Objective: 1. To evaluate the safety and tolerability of Vacc-4x 2. To evaluate the immunogenicity of Vacc-4x by evaluation of delayed type hypersensitivity and to compare the delayed type hypersensitivity response to immunologic endpoints and to CD4 chages during the 24 week antiretroviral free period 3. To evaluate the effect of Vacc-4x on CD8 counts and HIV viral RNA;Primary end point(s): 1. The proportion of subjects who meet the criteria for resumption of antiretroviral therapy (CD4 count falls below 350 x 10^6/L or decreases by => 50% on two consecutive tests or whose viral load increases above 300 000 copies/mL on three consecutive tests [each retest should be within two weeks of the last test]) between the interruption of antiretroviral therapy at week 28 and the end of the study at week 52 2. Percent change in CD4 count between week 28 (interruption of antiretroviral therapy) and the last CD4 count assessment made prior to resumption of antiretroviral therapy or week 52 if subject did not resume antiretroviral therapy between week 28 and 52 | — |
Countries
Germany, Italy, Spain, United Kingdom
Outcome results
None listed