HIV-1 infection is a chronic viral infection caused by human immunodeficiency virus type 1 that progressively impairs immune function if untreated. Advanced disease can lead to opportunistic infections and AIDS. Effective antiretroviral therapy suppresses viral replication and substantially improves survival and transmission prevention.
The FDA is set to make decisions on four drug applications in April 2026, including Orca-T for hematological malignancies, orforglipron for obesity, sparsentan for kidney disease, and a doravirine/islatravir combination for HIV-1.
Phase 3 LATITUDE trial shows monthly cabotegravir-rilpivirine injections cut regimen failure risk by 18.4 percentage points compared to daily oral ART in HIV patients with documented adherence difficulties.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07596888 |
IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study |
NOT_YET_RECRUITING | PHASE1 |
| NCT07579546 |
PERsistance of Long-Acting inJEctable CAB+RPV in a Cohort of Virologically-suppressed PLWH: a Real-life Study |
NOT_YET_RECRUITING | |
| NCT07357584 |
Efficacy and Safety of Doravirine in the Rapid Initiation |
NOT_YET_RECRUITING | PHASE4 |
| NCT07293559 |
Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States |
RECRUITING | |
| NCT07115368 |
Study of GS-1219 in Participants With HIV-1 |
TERMINATED | PHASE1 |
| NCT07081763 |
Immunotherapy With Baricitinib and Sirolimus, Alone and in Combination, for the Control of HIV-1 Replication After Antiretroviral Treatment Interruption |
NOT_YET_RECRUITING | PHASE2 |
| NCT07080138 |
Research on the Psychological Status of Patients With HIV-1 Infection |
NOT_YET_RECRUITING | |
| NCT07055451 |
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT07001319 |
Study of GS-3242 in Participants With HIV-1; Substudy-05 |
COMPLETED | PHASE1 |
| NCT06987318 |
A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection |
NOT_YET_RECRUITING | PHASE1 |
