Phase II vaccination trial in HIV-1 infected subjects

Phase 1

Conditions: Chronic HIV-1 infection
MedDRA version: 19.0Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2016-002724-83-BE

Lead Sponsor: Erasmus MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

1.= 18 years of age;
2.Voluntarily signed informed consent;
3.Proven HIV-1 infection (with documented antibodies against HIV-1 and a detectable plasma HIV-1 RNA before initiation of therapy);
4.On stable treatment with cART regimen (antiretroviral therapy consisting of at least three registered antiretroviral agents) for at least 3 years;
5.Nadir CD4+ = 350 cells/µl (up to 2 occasional determinations = 350 cells/µl are allowed);
6.Current CD4+ cell count = 450 cells/µl;
7.HIV-RNA below 50 copies/mL in the last 6 months prior to randomization, during at least two measurements (occasional so called ‘blips’ = 500 copies/mL are permitted);
8.If sexually active, willing to use a reliable method of reducing the risk of transmission to their sexual partners during treatment interruption (including PrEP).
a.For heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; IUD/IUS; consistent record with condoms; physiological or anatomical sterility (in self or partner) from 14 days prior to the first vaccination until 4 months after the last vaccination.
b.For heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination.

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 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Treatment with non-cART regimen prior to cART regimen;
2.Previous failure to antiretroviral and/or mutations conferring genotypic resistance to antiretroviral therapy;
3.Non-subtype B HIV infection;
4.Active Hepatitis B virus and/or Hepatitis C virus co-infection;
5.History of a CDC class C event (see appendix A);
6.Pregnant female (screened with a positive pregnancy test), lactating or intending to become pregnant during the study;
7.Active malignancy = 30 days (extended period on the clinical assessment of the investigator) prior to screening;
8.Active infection with fever (38°C or above) = 10 days of screening and/or first vaccination;
9.Therapy with immunomodulatory agents (e.g. systemic corticosteroids), including cytokines (e.g. IL-2), immunoglobulins and/or cytostatic chemotherapy = 90 days prior to screening. This does not include seasonal influenza, hepatitis B and/or other travel related vaccines;
10.Congenital, acquired or induced coagulation disorders, such as thrombocytopenia (thrombocytes < 150x109/L) and/or current use of anti-coagulant medication (e.g. coumarins, inhibitors of Xa); Usage of NSAIDs (including acetylsalicylic acid) is allowed, however it is advised to interrupt therapy 10 days ahead of vaccination;
11.Usage of any investigational drug = 90 days prior to study entry;
12.An employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of an employee or the investigator
13.Any other condition, which, in the opinion of the investigator, may interfere with the evaluation of the study objectives