5 Clinical Trials for Various Conditions
Background: People with HIV usually take a combination of 2 or more anti-HIV drugs daily to help manage their infection. Sometimes, however, HIV becomes resistant to these drugs, and the infection cannot be treated. Untreated HIV infection can make people more vulnerable to other infections as well as some cancers. Better treatments are needed for people with drug-resistant HIV. Objective: To see if a study drug (UB-421) is effective in people with drug-resistant HIV. Eligibility: People aged 18 years and older with HIV that is resistant to anti-HIV drugs. Design: Participants will be in the study for 35 weeks. Participants will have separate screening and baseline visits within 2 months of each other. They will have a physical exam with blood and urine tests both times. On the second visit, they will undergo apheresis: Blood will be drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in the other arm. Participants will begin receiving the study drug 1 week after their baseline visit. UB-421 is given through a tube attached to a needle placed in a vein in the arm. They will return for UB-421 treatments every week for 26 weeks. Each visit will take 3 to 6 hours. Participants will have 2 follow-up visits 4 and 8 weeks after their last treatment with UB-421. Apheresis will be repeated at 1 of these visits.
The primary objectives are to assess the antiviral activity, clinical safety and tolerability parameters of albuvirtide/3BNC117 combination therapy in reducing HIV-1 viral load during the 1-week induction period treatment period.
The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen (functional monotherapy) in people with human immunodeficiency virus (HIV) (PWH) with multi-drug resistance (MDR).
The current study proposal is an open label observational trial for maintenance of virologic suppression, and is designed as a non- inferiority switch trial. The study will involve approximately 30 patients, which includes a PK arm of approximately 10 patients. The study will also include secondary outcomes of quality of life (QOL) and weight changes Hypothesis: Patients with prior NUC or NNRTI resistance (but not to rilpivirine or doravirine) will maintain their virologic suppression after a drug regimen switch from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine. The switch therapy will avoid food interactions, and will be well tolerated by subjects.
In the SHIELD study, the study sponsor seeks to assess safety, PK and antiviral activity for children and adolescents with dual or triple class resistance. It will also assess the acceptability and swallowability of formulation among the pediatric population. The dose selection of FTR for children and adolescents ≥20kg utilized a population pharmacokinetic (POP PK) model-based approach to achieve similar adult TMR exposures following FTR 600mg BID administration with combination therapy that was demonstrated to be safe and effective in the FTR Phase 3 BRIGHTE study in HTE patients.