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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date06 Mar 2018 |
Phase 1b Single Dose Clinical Trial of a Novel Long-Acting Bispecific Antibody in People With HIV to Inform Development for HIV Pre- and Post-Exposure Prophylaxis
This is an open-label phase 1b clinical trial enrolling people living with HIV (PLWH) who are antiretroviral therapy (ART)-naïve or have not been on ART for > 24 weeks. This study will enroll PLWH to assess the safety, tolerability, and antiviral effect of bispecific and long-acting bNAbs, alone and in combination. The study will be conducted as a single center study at National Institute for Medical Research-Mbeya Medical Research Center (NIMR-MMRC) in Mbeya, Tanzania.
20 PLWH will be sequentially enrolled into one of 5 arms, each arm comprised of 4 participants. Sequential enrollment will occur in the following order:
Arm 1 will receive standard daily oral ART.
Arm 2 will receive a single dose of 10E8.4/iMab 600mg intravenous injection (IV).
Arm 3 will receive a single dose of 10E8.4/iMab 600mg intramuscular injection (IM).
Arm 4 will receive a single dose of 10E8.4/iMab 1800mg IV.
Arm 5 will receive a single dose of combination therapy with both 10E8.4/iMab 1800mg IV and VRC07-523LS 1200mg IV.
External Comparison of Effectiveness of Ibalizumab in Clinical Trials vs. Other HTE Regimens in OPERA
Among heavily treatment experienced people living with HIV, the virologic effectiveness of ibalizumab + optimized background regimen from two clinical trials will be compared to non-ibalizumab-containing regimens in routine clinical care in the OPERA cohort.
100 Clinical Results associated with Viral fusion proteins x CD4
100 Translational Medicine associated with Viral fusion proteins x CD4
0 Patents (Medical) associated with Viral fusion proteins x CD4