Basis and Statistical Design of the Passive HIV-1 Antibody Mediated Prevention (AMP) Test-of-Concept Efficacy Trials.

Background: Anti-HIV-1 broadly neutralizing antibodies (bnAbs) have been developed as potential agents for prevention of HIV-1 infection. The HIV Vaccine Trials Network and the HIV Prevention Trials Network are conducting the Antibody Mediated Prevention (AMP) trials to assess whether, and how, intravenous infusion of the anti-CD4 binding site bnAb, VRC01, prevents HIV-1 infection. These are the first test-of-concept studies to assess HIV-1 bnAb prevention efficacy in humans.

Development of a PIV-vectored RSV vaccine: preclinical evaluation of safety, toxicity, and enhanced disease and initial clinical testing in healthy adults.

MEDI-534 is a bivalent live attenuated vaccine candidate against human respiratory syncytial virus (hRSV) and human parainfluenza virus type 3 (hPIV3) that was previously shown to be immunogenic and to protect rodents and African green monkeys from wild-type (wt) hRSV challenge. We performed further preclinical evaluations to address the safety of MEDI-534 prior to human testing. MEDI-534 did not predispose rodents to enhanced RSV disease following wt-RSV challenge, and the tissue tropism of the chimeric virus was confined to the respiratory tract.

Survival times and complications of catheters used for outpatient parenteral antibiotic therapy in children.

Outpatient parenteral antibiotic therapy is routinely used in pediatrics, but few data are available on catheter-associated complications and survival times. Catheter-associated complications, defined as mechanical or nonmechanical, and survival times in peripherally inserted central catheters and central venous catheters used for outpatient parenteral antibiotic therapy in childhood were compared. The life test procedure was performed to determine survival time.

Sertraline treatment of pathological gambling: a pilot study.

Objective: Several open-label and double-blind studies have suggested that selective serotonin reuptake inhibitors may be useful in the treatment of pathological gambling. The purpose of this study was to evaluate the efficacy of sertraline in the treatment of pathological gambling.

Method: Sixty patients meeting the DSM-IV criteria for pathological gambling were treated for 6 months in a double-blind, flexible-dose, placebo-controlled study of sertraline 50 to 150 mg/day.

Outpatient parenteral antimicrobial therapy in osteoarticular infections in children.

There are few data on the use of outpatient parenteral antimicrobial therapy (OPAT) in the management of osteoarticular infections (OAIs) in childhood. The objective of this study was to determine if OPAT is safe and effective in the management of OAIs. Using their OPAT database, the authors evaluated the use of OPAT in children younger than 18 years old treated for OAIs between January 1, 1995, and December 31, 1999.