Safety of and Immune Response to a DNA HIV Vaccine (VRC-HIVDNA009-00-VP) in HIV Infected Individuals With Acute HIV Infection
Completed · Phase 1/Phase 2
Conditions studied: HIV Infections
In brief
The purpose of this study is to evaluate whether the HIV vaccine VRC-HIVDNA009-00-VP will be safe in individuals who started antiretroviral therapy during acute HIV-1 infection. The study will also test whether the vaccine can increase the immune system function in these participants.
Key facts
- Study ID
- NCT00125099
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 21
- Expected to finish
- 2007-09-01
- Last updated by the study team
- 2021-11-01
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Treated acute HIV-1 infection (initiated HAART during the acute retroviral syndrome AND were diagnosed by a positive HIV-1 viral load and a negative or indeterminate Western blot)
- Minimum of 6 months of HAART, defined as 2 or more antiretroviral drugs in combination
- At least three CD4 cell counts over 350 cells/mm3 for a period of 6 months prior to study entry
- Screening CD4 cell count over 350 cells/mm3 within 30 days prior to study entry
- HIV-1 RNA levels over 50 copies/ml for a period of 6 months prior to study entry
- Screening HIV-1 RNA level less than 50 copies/ml within 30 days prior to study entry
- Agrees to use acceptable methods of contraception
You may not qualify if…
- History of serious adverse reactions to vaccines
- History of CD4 cell count less than 250 cells/mm3, opportunistic infections, or AIDS-defining illnesses. Patients who have had one CD4 count less than 250 cells/mm3 or who have had CD4 counts less than 250 cells/mm3 for not more than 2 weeks during acute infection are not excluded.
- History of autoimmune disease, immunodeficiency, asthma, diabetes requiring insulin or oral hypoglycemics, thyroid disease, bleeding disorder, active malignancy, viral hepatitis, or asplenia
- Positive HBV, HCV, or syphilis test
- Suspected allergy or adverse reaction to any component of the study agent
- Changes in antiretroviral regimen within 6 months prior to entry due to virologic failure (not including toxicities)
- Previous participation in STIs
- Pregnancy or breast-feeding
- Live attenuated vaccines or investigational research agents within the 30 days prior to study entry
- Blood products within the 120 days prior to study entry
- Immunoglobulin within the 60 days prior to study entry
- Subunit or killed vaccines or allergy treatments with antigen injections within the 14 days prior to study entry
- Prior experimental HIV vaccines
- Certain immunosuppressive medications within the 6 months prior to study entry
- Current TB prophylaxis or therapy
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Serious illness requiring systemic treatment and/or hospitalization. An individual who has either completed therapy OR is clinically stable for at least 14 days prior to study entry is eligible.
- Anti-dsDNA antibody greater than the upper limit of normal
Where it is running
- Ucsd, Avrc Crs — San Diego, California, United States
- Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
- Brigham and Women's Hosp. ACTG CRS — Boston, Massachusetts, United States
- Aaron Diamond AIDS Research Ctr. AIEDRP — New York, New York, United States
- UW Primary Infection Clinic CRS — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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