Study Summary:
The purpose of this study is to evaluate the safety and tolerability of 3 infusions of KD-247 over 2 weeks in HIV-1 seropositive individuals to determine the pharmacokinetic parameters of KD-247 when administered as above and to assess the effect of KD-247 infusions on plasma HIV-1 ribonucleic acid (RNA) load and on CD4+ T cell counts.
Qualified Participants Must:
• Be 18-64 years of age
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Have HIV-1 infection confirmed by enzyme immunoassay (EIA) and immunoblot
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Demonstrate an HIV-1 RNA copy number between 1000 and 100,000 copies/mL on 2 measurements at least 2 weeks apart. Measurements taken during screening and/or on a prior non-study related medical visit within 3 to 6 weeks of Study Day 1 may be considered
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Have CD4+ T cell count >350 cells/mm3 on 2 measurements at least 2 weeks apart. Measurements taken during screening and on one prior non-study medical visit within 3 to 6 weeks of Study Day 1 may be considered
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Be treatment naïve or have been off antiretroviral drugs for at least 8 weeks prior to screening
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By genotyping, have a sequence of the portion of the HIV envelope gene encoding the principal neutralizing determinant that is consistent with neutralization by KD-247
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Weigh 45-120 kg
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Have an absolute neutrophil count >1000 cells/uL, hemoglobin (Hgb) >10 g/dL, and platelets >100,000/uL
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Have serum creatinine ≤1.5 mg/dL and alanine transaminase (ALT) <2.5 times the upper limit of normal
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Have a 12-lead electrocardiogram (ECG) without clinically significant abnormalities in the opinion of the investigator
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Female subjects must be:
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Women of non-childbearing potential, defined as either surgically sterile or at least 1-year post-menopausal (no menstrual periods for at least 2 years), or
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Women of childbearing potential using a highly effective method of contraception, and
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Women of childbearing potential with a negative serum beta human chorionic gonadotropin (β-HCG) test result at screening and within the 24 hours prior to administration of study drug. A negative urine pregnancy test within the 24 hours prior to administration of study drug will be acceptable, if the serum pregnancy test result is not yet available
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For heterosexual male subjects, the subject and the subject's sexual partner must agree to use acceptable methods of contraception during the entire study. Acceptable methods include, but are not limited to, intrauterine device, diaphragm with spermicide, condoms, or abstinence. Oral contraceptives alone are not an acceptable method of birth control
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Be willing and able to provide written informed consent
Qualified Participants May Receive:
Medical care, and compensation for time & travel.