A Study of Anti-HIV Monoclonal Antibody KD-247 (NCT00917813) | Clinical Trial Compass
CompletedPhase 1
A Study of Anti-HIV Monoclonal Antibody KD-247
United States27 participantsStarted 2007-09
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. Have HIV-1 infection confirmed by enzyme immunoassay (EIA) and immunoblot.
✓. Are male or female subjects, age 18-64 years.
✓. 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.
✓. 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.
✓. Are treatment naïve or have been off antiretroviral drugs for at least 8 weeks prior to screening.
✓. 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.
✓. Weigh 45-120 kg.
✓. Have an absolute neutrophil count \>1000 cells/uL, hemoglobin (Hgb) \>10 g/dL, and platelets \>100,000/uL.
Exclusion criteria
✕. Have a history of an acquired immune deficiency syndrome (AIDS)-defining illness or symptomatic HIV disease (i.e., Centers for Disease Control \[CDC\] Class B or C).
✕. Have received monoclonal antibody therapy of any kind in the past.
✕
Trial details
NCT IDNCT00917813
SponsorThe Chemo-Sero-Therapeutic Research Institute
. Received vaccinations in the past 15 days prior to study entry.
✕. Received antihistamines in the 6 weeks prior to study entry.
✕. Received non-steroidal anti-inflammatory drugs (NSAIDs) in the 5-6 days prior to skin test.
✕. Any history of anaphylaxis, asthma, hypersensitivity reaction to a vaccine or drug infusion, angioedema, or urticaria.
✕. Have been treated with any of the following within the 3 months prior to screening: interferons, cytokines, or other immunomodulators; immunoglobulin therapy; systemic corticosteroids; cytotoxic drugs; or ionizing radiation.
✕. Have received any investigational agent within 60 days prior to screening.