HIV/AIDS
Conditions
Interventions
Placebo comparaotr
Peptides in CAF01 (AFO18)
Sponsors
Statens Serum Institut (Helle Bossen Konradsen)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV - 1 seropositive with measurable viral load > 10e3 copies/ml and CD4+Tcell count > 400 CD4+cell/ul 2. Not in Antiretroviral therapy (>1year) 3. male or female aged between 18 - 50 years 4. Normal values for the area of liver and kidney enzymes, blood cell count with differential counts (eg white blood cells, lymphocytes, platelets/thrombocytes) and Hemoglobin 5. Expected to follow instructions 6. Written informed consent after oral and written information
Exclusion criteria
Exclusion criteria: 1. Vaccinated with other vaccines within 3 months before the first vaccination 2. Treated with immune modulating medicine within 3 months before the first immunization 3. Other important active chronic infectious diseases likely to influence the HIV-1 infection, like HIV-2,HBV, HCV adn TB 4. Significant medical disease as judged by the investigators, for example, severe asthma/COLD, badly regulated heart disease, insulin dependent diabete mellitus 5. Severe allergy or earlier analphylactic reactions 6. Active autoimmune disease 7. Simultaneous treatment with other experimental drugs 8. Laboratory parameters outside the 'normal' range for teh area and which are considered clinically significant 9. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate tolerability and safety of treatment;Safety and tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| evaluate the clinical effect measured as induction of new T-cell immune response, lowering of viral load, and increase in the CD4 cell count;immunogenicity;Lowering of HIV RNA viral load | — |
Countries
Guinea-Bisseu
Contacts
Public ContactAnders Fomsgaard
MD, Chielf of Lab / Statens Serum Institut
Outcome results
None listed