Phase 3 N=8,657 Evaluation of Diagnostic HIV Ag/Ab Combo Assay
Human Immunodeficiency Viruses
Primary: Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection — 37; 14; 0; 6113 Blood Specimens
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=51 TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals
HIV-1-infection
Primary: Safety of TMB-365 and TMB-380 Given Intravenously (Sentinel and Core) — 0; 0; 0; 0 Participants
Phase 1 N=23 A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults
HIV
Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration — 3; 2; 2; 3 Participants
Phase 1 N=10 A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
HIV
Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CAP256V2LS Product Administration — 5; 4; 0; 1 Participants
Phase 1 N=16 Phase 1, Open-label, Single Dose Study to Examine Safety, Tolerability, Pharmacokinetics and Virologic Impact of VRC01LS or VRC07-523LS in HIV-infected Viremic Adults
HIV-1
Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 3 Days After VRC01LS or VRC07-523LS Administration — 7; 6; 0; 3 Participants
Phase 1 N=26 VRC 605: Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or Subcutaneously to Healthy Adults
HIV Prevention
Primary: Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration — 3; 3; 3; 2 Participants
Phase 4 N=113 Anti-HIV Medications for People Recently Infected With HIV
HIV Infections
Primary: Total Treatment-free Time to Initiation of Permanent HAART — 18; 18 months
Phase 1 N=6 3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals
Human Immunodeficiency Virus
Primary: Grade 3 and Serious Adverse Events — 0 Participants
Phase 3 N=24,111 Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay
Healthy Donors · HIV Positive
Primary: PRISM HIV O Plus Test Data for Specificity — 10; 15589 participants
Phase 2 N=113 Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1
HIV
Primary: The Proportion of Patients Achieving Undetectable Viral Loads at Week 24. — 44; 28 percentage of participants
Phase 2 N=192 H1N1 Vaccine at Two Dose Levels in HIV Positive Adults
Influenza
Primary: Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza…
N/A N=322 HIV Oral Testing Infographic Experiment
HIV/AIDS
Primary: HIV Self-testing Knowledge — 3.24; 3.79 score on a scale
Phase 1 N=36 Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)
Infection, Human Immunodeficiency Virus · HIV Infections
Primary: Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call — 25; 15; 8; 20 Participants
Phase 2 N=16 3BNC117 Monoclonal Antibody in HIV-infected Subjects During Treatment Interruption
HIV-1 Infection
Primary: Number of Participants With Virologic Rebound at 8 Weeks After Interruption of Antiretroviral Therapy — 4; 3 Participants
Phase 1 N=33 Therapeutic Vaccine for HIV
HIV · Therapeutic Vaccine
Primary: The Rate of Related Adverse Events in Subjects Who Began cART During Acute or Early HIV-1 Infection. — 0; 0 Related Adverse Events
Phase 3 N=79 Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1
HIV
Primary: Safety and Tolerability of Ibalizumab + OBR — 8; 9 participants
Phase 1 N=24 Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection
HIV Infections
Primary: Number of Participants With Grade 3 or Greater mAb-related Reactogenicity and mAb-related Adverse Events (AEs) — 0; 0; 1 Participants
N/A N=300 HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting
Hiv · HIV Infections · AIDS
Primary: Prevalence of HIV Infection — 6 Participants
Phase 1 N=33 Phase I, Open-Label, Dose-Escalation Study of a Human Monoclonal Antibody, VRC-HIVMAB091-00-AB (N6LS), Administered Intravenously or Subcutaneously With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
HIV Antibodies
Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20 — 3; 1…
Phase 4 N=16 HIV Persistence and Viral Reservoirs
HIV · HIV Infections
Primary: Mean Change in Estimated Ultrasensitive Plasma HIV RNA Levels Between Baseline and Week 24 — 66 fold decrease in signal/cutoff ratio
Phase 1 N=95 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
HIV Infections
Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness — 3; 2; 2; 3 Participants
Phase 2 N=58 ARVs to Prevent Breastmilk HIV:Viral and Immune Responses
HIV Infections
Primary: Outcome 1: Serial HIV-1 RNA Levels in Breastmilk. — 2.74; 2.03; 1.70; 1.70 Log10 Viral load copies/ml
Phase 1 N=40 Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART)
HIV Infections
Primary: Number of Participants Who Experienced Grade 3 or Greater, Treatment Related, Adverse Event (AE) — 0; 0 Participants
N/A N=106 Secondary HIV Prevention and Adherence Among HIV-infected Drug Users
Risk Behavior · Medication Adherence · HIV
Primary: Number of Participants in Each Condition With Optimal ART Adherence — 27; 29 participants
Phase 4 N=182 Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults
Hepatitis B Vaccine
Primary: Number and Percentage of Participants With Anti-HBs Seroconversion at Month 7 — 75; 69 Participants
Phase 2 N=1,924 Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women
HIV Infections
Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness — 476; 496; 506; 1002 Participants
Phase 2 N=536 Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
Streptococcal Infections · Gram-Positive Bacterial Infections · Bacterial Infections
Primary: Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth — 2.07; 2.31; 3.98; 1.01 μg/mL
N/A N=419 Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay
HIV
Primary: Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis — 100; 99.06; 95.83 Percentage of True Results
Phase 2 N=19 Safety and Therapeutic Efficacy of the VRC01 Antibody in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection
HIV Infections
Primary: Number of Participants With Serious Adverse Event — 0; 0 Participants
Phase 1 N=27 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
HIV Infections
Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness — 5; 6; 6; 7 Participants