First In Human Study Of Broadly Neutralizing Antibodies To Control Hiv
Posted Date: Jun 11, 2019
- Investigator: Carl Fichtenbaum
- Type of Study: Drug
A5377 is a phase I, first-in-human, ascending dose study of SAR441236. It will include two arms with four cohorts in each. A ninth cohort may be enrolled. The DURATION is 24 or 72 weeks: Participants will be on study for 24 weeks, with the exception of participants in Cohort 4 who will be on study for 72 weeks. The number of persons to enroll will be between 54-60 evaluable participants: 6 participants each in Cohorts 1-3 and 5-8, and 12 in Cohort 4. If warranted, a ninth cohort of six participants may be enrolled. In Arm A: Adults with HIV-1, 18 to 70 years of age on suppressive combination antiretroviral therapy (ART) with plasma HIV-1 RNA levels =50 copies/mL for at least 12 months and CD4 count of =200 cells/mm3. Arm B: Treatment-naïve adults with HIV-1, 18 to 70 years of age with plasma HIV-1 RNA >5000 copies/mL and <100,000 copies/mL and CD4 count of =350 cells/mm3 who intend to initiate combination ART.
Hiv Infection With Undetectable Hiv Level And Cd4 T-Cell Count > 200 On Treatment Or >350 Who Intend To Start Treatment
Hiv, Broadly Neutralizing Antibodies
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