FDA grants Priority Review for Gilead's bictegravir/lenacapavir single-tablet HIV regimen. The NDA is supported by ARTISTRY-1 and ARTISTRY-2 trials showing noninferiority. A PDUFA target date of August 27, 2026 has been set.
Two research teams have developed catalytic methods for synthesizing chiral sulfur compounds with antiviral potential. One approach uses an organocatalytic strategy to create vinyl sulfinamides that bind to SARS-CoV-2 and HIV-1 proteins, while another employs copper catalysis for high-yield production of chiral sulfilimines. Both methods address critical gaps in accessing valuable chemical space for drug discovery.
Merck announced Phase 3 trial results for its investigational once-daily, two-drug HIV regimen doravirine/islatravir at CROI 2026, demonstrating non-inferiority to standard treatment in treatment-naïve adults with viral suppression rates of 91.8% at Week 48.
A once-daily single-tablet combination of bictegravir and lenacapavir demonstrated non-inferiority to existing HIV treatments in Phase 3 trials, offering simplified treatment for people living with HIV who are virologically suppressed.
An international research team has identified antibody 007, which targets HIV-1's V3 glycan site without depending on sugar structures the virus frequently alters, remaining effective against resistant variants and enhancing combination therapies.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07481175 |
Inhibiting the Anti-apoptotic Factor, BCL-2, at the Time of ART Initiation to Promote Apoptosis of HIV-infected Cells and Restrict the Seeding of the HIV Reservoir (The INITIATE Study) |
RECRUITING | PHASE1 |
| NCT07122557 |
Real World Effectiveness of Bictegravir/Emtricitabine/Tenofovir Alafenamide(BIC/FTC/TAF) in PLWH in Precarity Settings in France -IMEA073 |
NOT_YET_RECRUITING | |
| NCT06967753 |
Switch to Dolutegravir Plus Lamivudine Dual-Therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH) |
RECRUITING | PHASE4 |
| NCT06680479 |
Safety and Immunogenicity of Stabilized CH505 TF chTrimer Vaccination in Adults Living With HIV-1 on Suppressive Antiretroviral Therapy |
SUSPENDED | PHASE1 |
| NCT06517693 |
Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1 |
RECRUITING | PHASE1 |
| NCT06458504 |
Viral Infection of HSPC Impacts Hematopoiesis |
RECRUITING | |
| NCT06252402 |
CMV-specific HIV-CAR T Cells as Immunotherapy for HIV/AIDS |
RECRUITING | EARLY_PHASE1 |
| NCT05944848 |
A Study of CL-197 Capsules in Healthy Participants |
COMPLETED | PHASE1 |
| NCT05700734 |
MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002) |
WITHDRAWN | PHASE1 |
| NCT05612178 |
A Study to Evaluate the Safety and Effects of Repeated Doses of 3BNC117-LS and 10-1074-LS on Persistent Viral Reservoirs in People Living With HIV and on Suppressive Antiretroviral Therapy |
ACTIVE_NOT_RECRUITING | PHASE1 |
