Status:
COMPLETED
HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease
Lead Sponsor:
Statens Serum Institut
Collaborating Sponsors:
Ministry of the Interior and Health, Denmark
European and Developing Countries Clinical Trials Partnership (EDCTP)
Conditions:
Aids, Cdc Group I
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Treatment: Immunization with peptide-mix and adjuvant. The vaccine should induce cellular immunity against HIV-1. Target group: Untreated healthy individuals with chronic HIV-1 infection. Purpose: T...
Detailed Description
The HIV infection does not leave lifelong immunity, but leads to break down of the immune system, opportunistic infections and death. The immunity obtained by the infection itself can only partially c...
Eligibility Criteria
Inclusion
- HIV-1 seropositive with measurable viral load \>10e3 copies/ml and CD4+ T-cell count \>400 CD4+ cells/µl.
- Not in Antiretroviral Therapy (\>1 year).
- Male or female with age between 18 and 50 years.
- 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
- Expected to follow the instructions.
- Written informed consent after oral and written information.
Exclusion
- Vaccinated with other vaccines within 3 months before the first vaccination.
- Treated with immune modulating medicine within 3 month before the first immunization.
- Other important active chronic infectious diseases likely to influence the HIV-1 infection, like HIV-2, HBV, HCV and TB
- Significant medical disease as judged by the investigators, for example severe asthma/COLD, badly regulated heart disease, insulin-dependent diabetes mellitus.
- Severe allergy or earlier anaphylactic reactions.
- Active autoimmune diseases.
- Simultaneous treatment with other experimental drugs.
- Laboratory parameters outside the 'normal' range for the area and which are considered clinically significant.
- Pregnancy
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01141205
Start Date
August 1 2009
End Date
June 1 2012
Last Update
August 8 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Nacional Simao Mendes
Bissau, Guinea-Bissau, Guinea-Bissau
2
Hospital Nacional Simao Mendes
Bissau, Guinea-Bissau