10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults (NCT05890963) | Clinical Trial Compass
Active — Not RecruitingPhase 1
10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults
Tanzania20 participantsStarted 2023-11-28
Plain-language summary
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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Able to read and write in Kiswahili and/or English
✓. Able and willing to provide written informed consent
✓. Passes Test of Understanding (TOU)
✓. Aged 18-50 years, inclusive
✓. Antiretroviral Therapy (ART)-naïve or no ART for \> 24 weeks at the time of screening
✓. HIV RNA 1,000-100,000 copies/mL
✓. CD4 ≥ 500 cells/mm3
✓. Laboratory criteria at screening within protocol-specified limits for blood, chemistry and urinalysis
Exclusion criteria
✕. Weight \>100 kg
✕. Previous receipt of humanized or human monoclonal antibody whether licensed or investigational (other than for the prevention and/or treatment of SARS-CoV2/COVID-19)
What they're measuring
1
Number of Grade 3 or higher antibody-related reactogenicity and adverse events
Timeframe: Up to Week 48 in Step 2
2
Change in plasma HIV RNA from day 0 to day 14
Timeframe: Day 0 and Day 14 in Step 1
3
Proportion of participants with HIV RNA < 50 copies/mL at day 14
. History of viral failure on two or more ART regimens
✕. Planned or anticipated need for enfuvirtide, maraviroc, fostemsavir, or ibalizumab for antiretroviral therapy.
✕. AIDS-defining illness, as enumerated by the WHO Stage 3 or 4, within the six months prior to enrollment
✕. Ongoing oral thrush
✕. Active injection or other recreational drug use within the previous 12 months that, in the opinion of the investigator, would impede the participant's ability to safely and consistently adhere to the study protocol
✕. History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis in the 2 years prior to enrollment.