Clinical Trial Search

Primary: Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment — 1.0 IU/L

Primary: Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs — 168; 110; 51; 10 participants

Primary: Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization — 219; 223 participants

Primary: Proportion of Participants With Treatment Failure — 0.0682; 0.0667 proportion of participants

Primary: Proportion of Women With Plasma HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery — .84; .94 Proportion — p=0.001

Primary: Proportion of Patients Free of Treatment Failure (Noncompleter = Failure) at 24 Weeks. — 30; 31; 0; 0 Participants

Primary: Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at…

Primary: Mean White Blood Cell Count Between Treatment Groups at 2 Months — 5904; 4918 white blood cells per microliter (mcL).

Primary: Mean Change in Estimated Ultrasensitive Plasma HIV RNA Levels Between Baseline and Week 24 — 66 fold decrease in signal/cutoff ratio

Primary: Undetectable Viral Loads During Treatment — 70.4; 42.5 percentage of blood samples undetectable — p=<0.001

Primary: Change in Bone Mineral Density (BMD) at Lumbar Spine and Left Hip From Baseline to Week 48 — 0.010; 0.013 g/cm² — p=0.0239

Primary: Proportion of Patients With Treatment Failure (TF) — 27.5; 15.4; 7.9; 15.4 percentage of patients

Primary: Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment — 551; 32 Participants

Primary: Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24. — 49 participants

Primary: Number and Percentage of Patients Achieving Virologic Resuppression — 256; 263 Participants

Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 3 Days After VRC01LS or VRC07-523LS Administration — 7; 6; 0; 3 Participants

Primary: Percentage of Participants With Treatment Failure Through Week 48 — 21.3 Percentage of Participants

Primary: Number of Participants in Each Group (Study Drug vs. Placebo) With Undetectable Plasma HIV-1 RNA, as Measured by an Ultra-sensitive Assay With a Limit of Detection of 1…

Primary: Proportion of Participants Who Remain on PRO 140 Monotherapy Regimen at the End of Week 48 Without Experiencing Virologic Failure — 0.23; 0.43; 0.45 proportion of…

Primary: Monotherapy: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) — -1.17; -2.15; -2.31; -0.28 Copies per milliliter…

Primary: Number of Participants With Confirmed Virologic Response (CVR) at Week 48 — 40 Participants

Primary: Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 12 as Defined by Pure Virologic Response (PVR)…

Primary: Time to Virologic Failure After Initiating PRO 140 Monotherapy. — 70.71 days — p=<0.0001

Primary: Proportion of Subjects With Sustained Virologic Response (SVR12) — 3; 2 Participants

Primary: Number of Participants With Viral Suppression — 289; 283 participants — p=0.55

Primary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm — 90.0; 92.0 percentage of participants — p=0.35

Primary: HIV-RNA Levels — 0; 24; 10; 107 participants — p=<0.001

Primary: Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks…

Primary: Longitudinal Analysis of Total HIV DNA and Immune-phenotype by Digital Droplet Polymerase Chain Reaction (PCR) and Flow Cytometry, Respectively, Comparing This Outcome…

Primary: Treatment Response at Week 48 — 126; 124; 250; 126 Patients — p=0.684