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HIV Study
(treatment and cure)
Investigator: Dr. Jacob Lalezari
CRISPR Study to Eradicate HIV
Sponsored by Excision BioTherapeutics, this is a First in Human (FIH), open-label, sequential cohort, single ascending dose study of EBT-101 (CRISPR) administered intravenously to aviremic HIV-1 infected adults on stable ART.
Participants will be asked to attend several visits for screening to determine eligibility. On Day 1, eligible participants will receive a single IV dose of EBT-101. All participants will be assessed for eligibility for an analytical treatment interruption (ATI) of their background ART at Week 12.
All participants will be followed through Week 48 (end of study). Participants are required to attend multiple study visits at the clinical site including daily visits for the first 14 days, followed by weekly visits after Week 12.
Eligible participants who are enrolled in the FIH study will also be enrolled in a separate Long Term Follow Up (LTFU) study for safety monitoring, lasting 15 years.
The study is open to male patients 18 – 70 years old who have been on antivirals for the last two years and have maintained a CD4 (T-cell count) of greater than 500 during that time. Additional inclusion criteria will be evaluated at a screening visit.
In the news:
"Cure for HIV Months Away..." (Daily Mail)
Excision BioTherapeutics Receives FDA Fast Track (globenewswire.com)
Checkpoint inhibitor to reverse HIV immune exhaustion Study
New study evaluates PD-1 & a4b7 immunotherapy directed to trigger and reprogram an immune response to be able to see and control the HIV virus in people living with HIV while stopping oral antiretroviral therapy with the aim of reaching a “functional cure”.
Quest Clinical Research is currently enrolling a phase II study sponsored by AbbVie to evaluate Budigalimab, an anti-PD-1 antibody that binds to cell surface expressed PD-1 and ABBV-382, an anti-anti-a4b7 integrin monoclonal antibody vs Placebo, for Chronic HIV+ patients who are virologically suppressed on stable non-NNRTI antiretroviral therapy and with T-cell levels above 500 cells/mL in the last 12 months.
Patients must have no history or current diagnosis of AIDS defining illness or autoimmune disease. This study includes an analytical treatment interruption at Day 1 and follows patients weekly for the first 12 weeks and then bi-weekly until they reach virologic failure. Study can pay up to $4000. Please call Ula for more information at 415-353-0800, ext 28.
American Gene Therapy Study
Phase 1b/2 Study to Measure Safety and Efficacy of AGT103-T Durable Anti-Retroviral Withdrawal Initiation II (DARWIN II):
Sponsored by American Gene Technologies, this First in Human (FIH) study is designed to evaluate the potential of gene-modified CD4 T cells (which are specific to an HIV protein called GAG) to provide long lasting suppression of HIV without the ongoing need for antiretroviral therapy.
Subjects will receive their own T cells back after they have been selected for GAG specificity, gene modified to prevent HIV infection, and grown up to tens of billions prior to re-infusion. This study will consist of a leukapheresis procedure, infusion of the modified cells, and two planned analytical treatment interruptions (ATIs).
The first short ATI attempts to stimulate an immune response, and the second ATI attempts to evaluate product efficacy.
Participants are required to attend weekly study visits at the clinical site up until week 16, with further visits to be determined. Eligible participants who are enrolled in the FIH study (AGT-HC170) will also be enrolled in a separate Long Term Follow Up (LTFU) study for safety monitoring.
This study is open to men and women, 18 – 60 years old, who have been on antivirals for the last two years with a CD4 (T-cell count) of greater than 450 at screening. Additional inclusion criteria will be evaluated at a screening visit.
TaiMed’s HIV Treatment Study
TaiMed HIV Study evaluates HIV treatments given once every 2 months.
A phase 2a study with TaiMed Biologics that combines two HIV attachment inhibitors (TMB-365 & TMB-380) as treatment for HIV+ individuals. Both treatments are monoclonal antibodies that will be administered by IV infusion once every 2 months.
or Call Dr. Jay
415-353-0800
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