Safety of and Immune Response to a DNA HIV Vaccine (VRC-HIVDNA009-00-VP) in HIV Infected Individuals With Acute HIV Infection
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acute Infection, Treatment Experienced, Treatment Interruption, HIV Therapeutic Vaccine
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Ucsd, Avrc Crs
- Massachusetts General Hospital ACTG CRS
- Brigham and Women's Hosp. ACTG CRS
- Aaron Diamond AIDS Research Ctr. AIEDRP
- UW Primary Infection Clinic CRS