Status:
COMPLETED
Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV
Lead Sponsor:
Bionor Immuno AS
Conditions:
HIV I Infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes signif...
Detailed Description
Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes signif...
Eligibility Criteria
Inclusion
- Age 18-55
- HIV positive at least one year
- Clinically stable on ART for at least six months
- Documented viral load less than 50 copies/mL for the last six months
- Documented prestudy CD4 cell count equal or more than 400x10exp6/L
- Nadir CD4 cell count equal or more than 200x10exp6/L
- Signed informed consent
Exclusion
- Reported pre-study AIDS-defining illness within the previous year
- Malignant disease
- On chronic treatment with immuno-suppressive therapy
- Unacceptable values of hematology and clinical chemistry parameters
- Current chronic infection such as HCV and HBV or active tuberculosis
- Pregnant or breastfeeding women
- Not using safe contraceptive methods
- Participation in other clinical trial
- Incapability of compliance
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00659789
Start Date
August 1 2008
End Date
June 1 2011
Last Update
February 23 2017
Active Locations (18)
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1
UCLA CARE Center
Los Angeles, California, United States, 90035
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048-8700
3
UC Davis Medical Center
Sacramento, California, United States, 95817
4
University of Miami School of Medicine
Miami, Florida, United States, 33136