Studies Implemented by Mt. Sinai Medical Center

Study Number Study Title Study Status Study Restriction

P1055

(10049)

Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents

Participants Off Study and Primary Analysis Completed

United States

P1053

(10131)

A Phase II, Randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Two Antiretroviral Therapeutic Strategies: A Dual PI-based HAART Regimen Versus a Multi-NRTI ART Regimen, in ART-Experienced Children and Youth Who Have Experienced Virologic Failure

Concluded

United States

P1047

(10163)

Phase II Safety and Immunogenicity Study of Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] L1 Virus-Like Particle [VLP] Vaccine (Gardasil¿) In HIV-Infected Children > 7 to < 12 Years of Age

Concluded

Not Applicable

P1045

(10108)

Prevalence of Morphologic and Metabolic Abormalities in Vertically HIV-Infected and Uninfected Children and Adolescents

Closed to Follow Up

United States

P1038

(10045)

A Phase I/II Safety, Tolerability, and Phamacokinetic Study of High Dose Lopinavir/Ritonavir with or without Saquinavir in HIV infected Pediatric Subjects Previously Treated With Protease Inhibitors

Concluded

Not Applicable

P1034

(10043)

Comparative Trial of Protease-Containing and Protease-Sparing HAART Regimens in HIV-Infected Adolescents with an Evaluation of Therapeutic Drug Monitoring

Concluded

United States

P1030

(10041)

A Phase I/II Study of Lopinavir/Ritonavir in HIV-1 Infected Infants <6 Months of Age

Concluded

Non-US

P1010

(10814)

Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children

Concluded

United States

P1006

(10036)

The Effects of Highly Active Antiretroviral Therapy (HAART) on the Recovery of the Immune Function in a Population on HIV-Infected Children and Young Adults

Concluded

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 219C

(10035)

Pediatric Late Outcomes Protocol

Participants Off Study and Primary Analysis Completed

Not Applicable

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.