the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients
NCT04041362 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2020-02-21
Summary
This study assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects.
Conditions
- HIV-1 Infection
Interventions
- BIOLOGICAL
-
UB-421
Monoclonal antibody by IV infusion plus standard ART
- OTHER
-
Antiretroviral Therapy (ART)
Standard ART
Sponsors & Collaborators
-
United BioPharma
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-04-30
- Primary Completion
- 2020-12-31
- Completion
- 2021-03-31
More Related Trials
-
A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1
NCT00824421 ·Status: COMPLETED ·Phase: PHASE2
-
The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment
NCT00005118 ·Status: UNKNOWN ·Phase: PHASE2
-
TMC125-C211: Trial of TMC125 in HIV-1 Infected Subjects Who Were in a Sponsor Selected TMC125 Trial
NCT00111280 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients
NCT00002415 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Reactogenicity and Immunogenicity of HB-502 and HB-501 Versus Placebo in People With HIV on Suppressive ART
NCT06430905 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects
NCT00363142 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)
NCT00293254 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants
NCT03928821 ·Status: COMPLETED ·Phase: PHASE1
-
A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir
NCT00002452 ·Status: COMPLETED ·Phase: PHASE2
-
TMC125-C203: Phase II Randomized (Patients Are Assigned Different Treatments Based on Chance), Placebo Controlled Dose Escalating Trial of TMC125 in HIV-1 Infected Patients
NCT00412646 ·Status: COMPLETED ·Phase: PHASE2
-
Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140
NCT02483078 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Evaluation of Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Ulonivirine (MK-8507) in Human Immunodeficiency Virus (HIV-1)-Infected Participants (MK-8507-003)
NCT02174159 ·Status: COMPLETED ·Phase: PHASE1
-
TMC125-C206: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.
NCT00254046 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection
NCT00414518 ·Status: COMPLETED ·Phase: NA
-
Phase II Study of the Safety and Surrogate Marker Efficacy of Butyldeoxynojirimycin (SC-48334) and AZT in Symptomatic HIV-1 Infected Patients With 200 - 500 CD4+ Cells/mm3. (NOTE: Asymptomatic HIV-1 Infected Patients Also Eligible)
NCT00002079 ·Status: COMPLETED ·Phase: PHASE2
-
Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir
NCT00708162 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of 1592U89 in Combination With Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
NCT00002440 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Indinavir Plus Ritonavir Plus Two NRTIs vs. Nelfinavir Plus Two NRTIs in HIV Positive Patients (0639-112)(COMPLETED)
NCT00541463 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of MKC-442 in Combination With Other Anti-HIV Drugs
NCT00002412 ·Status: COMPLETED ·Phase: PHASE2
-
A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants
NCT05184452 ·Status: COMPLETED ·Phase: PHASE1
-
Dual Therapy With Boosted Darunavir + Dolutegravir
NCT02486133 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in Human Immunodeficiency Virus (HIV)-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus
NCT03472326 ·Status: TERMINATED ·Phase: PHASE2
-
A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV Infection
NCT00002086 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)
NCT00293267 ·Status: COMPLETED ·Phase: PHASE3
-
3BNC117 and 10-1074 in ART-treated Individuals
NCT03526848 ·Status: COMPLETED ·Phase: PHASE1