Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT01141205
Eligibility Criteria:
Inclusion Criteria:
1. HIV-1 seropositive with measurable viral load \>10e3 copies/ml and CD4+ T-cell count \>400 CD4+ cells/µl.
2. Not in Antiretroviral Therapy (\>1 year).
3. Male or female with age between 18 and 50 years.
4. Normal values for the area of liver and kidney enzymes, blood cell count with differential counts (e.g. white blood cells, lymphocytes, platelets/thrombocytes) and Hemoglobin
5. Expected to follow the instructions.
6. Written informed consent after oral and written information.
Exclusion Criteria:
1. Vaccinated with other vaccines within 3 months before the first vaccination.
2. Treated with immune modulating medicine within 3 month before the first immunization.
3. Other important active chronic infectious diseases likely to influence the HIV-1 infection, like HIV-2, HBV, HCV and TB
4. Significant medical disease as judged by the investigators, for example severe asthma/COLD, badly regulated heart disease, insulin-dependent diabetes mellitus.
5. Severe allergy or earlier anaphylactic reactions.
6. Active autoimmune diseases.
7. Simultaneous treatment with other experimental drugs.
8. Laboratory parameters outside the 'normal' range for the area and which are considered clinically significant.
9. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01141205
Study Brief:
Protocol Section:
NCT01141205