Studies Implemented by Jacobi Medical Center Bronx

Study Number Study Title Study Status Study Restriction

P1115

(11954)

Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission: A Phase I/II Proof of Concept Study

Enrolling

US & Non-US

P1112

(11903)

Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous (SC) VRC01 and VRC01LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants

Enrolling

US & Non-US

P1110

(11891)

A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-1 Exposed Infants at High Risk

Enrolling

US & Non-US

P1097

(11790)

Raltegravir Pharmacokinetics and Safety in Neonates

Enrolling

United States

P1093

(11773)

Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of GSK1349572 (Dolutegravir), a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents

Enrolling

US & Non-US

P1090

(10850)

A Phase I/II, Open-Label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Etravirine (ETR) in Antiretroviral Experienced HIV-1 Infected Infants and Children, Aged >= 2 Months to < 6 Years

Enrolling

US & Non-US

P1080

(10768)

A Pilot Study of Psychiatric and Antiretroviral Medication Concentrations in HIV-1 Infected and Uninfected Children and Adolescents

Closed to Follow Up

United States

P1074

(10660)

A Prospective Surveillance Study of Long Term Outcomes in HIV-infected Infants, Children and Adolescents

Closed to Follow Up

United States

P1066

(10495)

A Phase I/II, Multicenter, Open-Label, Noncomparative Study of the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Group to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Raltegravir (Isentress™, MK-0518) in HIV-1 Infected Children and Adolescents

Closed to Follow Up

US & Non-US

P1026S

(10040)

Pharmacokinetic Properties of Antiretroviral Therapy during Pregnancy

Enrolling

US & Non-US

P1020A

(10037)

A Phase I/II, Open-Label, Pharmacokinetic and Safety Study of a Novel Protease Inhibitor (BMS-232632, Atazanavir, ATV, Reyataz) in Combination Regimens in Antiretroviral Therapy (ART)-Naive and Experienced HIV-infected Infants, Children and Adolescents

Participants Off Study and Primary Analysis Completed

US & Non-US

IMPAACT 2013

(30074)

Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, D46/NS2/N/delta M2-2-HindIII, Lot RSV#011B, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age

Enrolling

United States

IMPAACT 2012

(30073)

Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID cp delta M2-2, Lot RSV#009B, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age

Closed to Follow Up

United States

IMPAACT 2011

(30072)

Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID delta M2-2 1030s, Lot RSV#010A, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age

Closed to Accrual

United States

IMPAACT 2002

(12051)

Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression among Youth Living with HIV in the United States

Enrolling

United States

ACTG 390

(10106)

A Phase II/III Randomized Open-Label Study of Combination Antiretroviral Regimens and Treatment-Switching Strategies in Antiretroviral Naive Children 30 Days and to 18 Years of Age

Participants Off Study and Primary Analysis Completed

Non-US

ACTG 381

(10104)

Establishment and Maintenance of Long-Term Undetectable Plasma HIV-1 RNA: Correlation with Immunologic Reconstitution and Viral Dynamics

Concluded

Not Applicable

ACTG 219C

(10035)

Pediatric Late Outcomes Protocol

Participants Off Study and Primary Analysis Completed

Not Applicable

A5257

(10670)

A Phase III Comparative Study of Three Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Sparing Antiretroviral Regimens for Treatment-Naive HIV-1-Infected Volunteers

Closed to Follow Up

United States

1077HS

(10779)

HAART Standard Version of the PROMISE Study: Promoting Maternal and Infant Survival Everywhere

Closed to Follow Up

US & Non-US

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.