Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Age 18-50 yrs.
ART started within 18 mo. of last documented negative HIV Ab test, or within 13 mo. of last negative detuned HIV-1 Ab assay, or within 18 mo. of evolution of Western blot from indeterminate to positive in the presence of a positive Ab test
No changes to ART treatment within 4 wks. of study entry
Documentation of level of plasma HIV-1 RNA and CD4+ counts prior to ART
On stable suppressive ART [HIV-1 RNA < 50 copies/mL (PCR) or < 75 copies/mL (bDNA) for at least 6 mo. prior to starting vaccination]
No history of virologic failure
CD4+ > 500 cells/µL
Nadir CD4+ > 350 cells/µL unless measured in the setting of acute infection

Laboratory values:

Hemoglobin ≥ 10g/dL (male) or 9g/dL (women)
ANC > 1000 cells/µL
ALT, AST ≤ 2.5 ULN
Total bilirubin < 1.5 x ULN (≤ 5 x ULN on atazanavir)
Fasting glucose ≤ 125 mg/dL
Serum creatine < 1.5 x ULN
Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault)
Serum creatine phosphokinase (CPK) ≤ 1.5 x ULN
UA negative for hemoglobin and glucose and no greater than 1+ protein
Any abnormalities must be assessed by the investigator as not clinically significant
ECG without evidence of current or past MI, or ischemic heart disease
Willing to provide signed informed consent
Females: a negative serum or urine β-HCG pregnancy test at screening
Female subjects of reproductive potential who engage in sexual activity that could lead to pregnancy must agree to avoid pregnancy and agree to consistently use contraception for at least 21 days prior to first vaccination until the last protocol visit.
Male subjects participating in the study must agree to not attempt to impregnate a female, or participate in sperm donation programs
Males engaging in sexual activity that could lead to pregnancy must use a condom from the date of receipt of the first study vaccine until the last protocol visit
Agreement to use condoms for protection against HIV-1 transmission throughout the study
Participants must be willing to comply with all study requirements and expected to be available for the duration of the study
Participants must be willing to temporarily discontinue antiretroviral therapy for up to 12 wks. post-vaccinations

Exclusion Criteria:

Known infection with HIV-1 subtype other than Clade B
Chemotherapy for active malignancy in the past 12 mo.
Prior vaccinations with any HIV-1 vaccine
Prior vaccination against smallpox within the last 15 yrs.
History of or known cardiac disease
History of myositis
Diagnosis of HIV-associated nephropathy
Evidence of active HBV or HCV infection
Framingham Global Risk Assessment Score consistent with high short-term (10 yr.) cardiac risk
Receipt of immunomodulatory agents, systemic corticosteroids (including nonprescription street steroids), gamma globulin, or investigational agents (other than H1N1 influenza vaccine) within 6 mo. of screening
Any immunization within 1 mo. of screening and within 2 wks. of any inoculation in this study
Creatine supplements within 14 days of baseline and unwillingness to discontinue use throughout the trial
Changes in ART regimen prior to entry due to virologic failure (not including toxicity)
Pregnancy or breastfeeding
Any clinically significant diseases (other than HIV-1 infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise participant safety
Active alcohol or substance abuses
Allergy to chicken egg derived products
Contraindication to intramuscular injection
Unwilling to forego vigorous exercise 3 days prior to each vaccination