Clinical Trial Search

Primary: Part 1: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11 — -8605.8; -100719.8; -3406.5 Copies per milliliter

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: Number of Grade 3 or Higher Adverse Events — 0 Events

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

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: Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE) — 0 percentage of participants

Primary: Total Treatment-free Time to Initiation of Permanent HAART — 18; 18 months

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

Primary: Percentage of Participants With HIV-1 RNA <400 and >=400 Copies/mL Over 48 Weeks — 81; 82; 19; 18 Percentage of participants

Primary: Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the 1-week Double-blind Treatment Period — .64; .23; .36; .77…

Primary: Number of Participants With a Viral Load Measurement of <200 Copies/mL at Week 24 — 28 participants

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

Primary: Number of Participants With Treatment-Emerging Adverse Events — 1; 1; 4; 3 Participants

Primary: Confirmed Virologic Failure at or Prior to Week 48 — 95; 105; 34; 23 participants — p=0.133

Primary: Occurrence of Grade ≥ 1 Adverse Events (AEs) — 5; 26; 4 events

Primary: Percentage of Participants With Virologic Failure Endpoint as Per Food and Drug Administration (FDA) Snapshot Category at Week 48 — 0.3; 0.5 Percentage of participants

Primary: Change From Baseline in the Acceptability of Intervention Measure (AIM) Total Score in Staff Study Participants at Month 4 — 0.00 Scores on a scale

Primary: Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml — -3.16; -3.31; -3.26; -3.20 log10 HIV-1 RNA — p=0.26

Primary: Proportion of Participants Experiencing a Grade 3 or Higher Adverse Event (AE) or Premature Discontinuation Due to an AE (Regardless of Grade) That is Related To Step 2…

Primary: Change in Levels of CD8+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) From Baseline to Weeks 24 and 48 on ART — -4.01 % of CD8+ T-cells — p=0.001

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

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: Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) — 0.00; 0.00; 0.00; 0.10 Proportion of participants — p=0.48

Primary: Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo…

Primary: Number of Grade 2 or Higher Related Adverse Events — 11 Events

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

Primary: Number of Participants With Sustained Virologic Response (SVR) — 11; 11 participants

Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration — 3; 2; 2; 3 Participants

Primary: Time From Randomization to Virologic Failure — 36; 24; 24; 24 Weeks

Primary: Death — 0 Participants