Studies Implemented by Boston Medical Center Pediatric HIV Program

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, VRC01LS, and VRC07-523LS, 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

Closed to Follow Up

United States

P1093

(11773)

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

Enrolling

US & Non-US

P1086

(10835)

A Phase II Study to Assess the Safety and Immunogenicity of an Inactivated Swine-Origin H1N1 Influenza Vaccine in HIV-1 Infected Pregnant Women

Concluded

United States

P1083

(10787)

A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines

Participants Off Study and Primary Analysis Completed

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

Participants Off Study and Primary Analysis Completed

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

Participants Off Study and Primary Analysis Completed

US & Non-US

P1063

(10167)

Phase I/II Safety and Efficacy Investigation of Atorvastatin for Treatment of Increased LDL-Cholesterol in HIV-Infected children, Adolescents, and Young Adults

Concluded

United States

P1061s

(10132)

Evaluation of Immunologic Memory Following Pneumococcal, Hepatitis B, and Measles Vaccination in HIV-Infected Children Treated with Highly Active Antiretroviral Therapy (HAART)

Concluded

Not Applicable

P1057

(10270)

A Phase I/II Randomized Trial of the Safety and Immunogenicity of Cold Adapted Influenza Vaccine (FluMist) In HIV-Infected Children

Participants Off Study and Primary Analysis Completed

Not Applicable

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

Concluded

United States

P1039

(10046)

A Phase III Randomized Trial of the Safety and Antiretroviral Effects of Zidovudine/Lamivudine/Abacavir vs Zidovudine/Lamivudine/Lopinavir/Ritonavir in the Prevention of Perinatal Transmission of HIV

Concluded

Not Applicable

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

P1026S

(10040)

Pharmacokinetic Properties of Antiretroviral Therapy during Pregnancy

Enrolling

US & Non-US

P1024

(10269)

Evaluation of the Immunogenicity of Pneumococcal Conjugate Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Treated with Highly Active Antiretroviral Therapy

Concluded

Not Applicable

P1022

(10192)

A Randomized Trial of Protease Inhibitor- Including Vs Protease Inhibitor-Sparing Regimens for Women Who Initiate Therapy of HIV Infection During Pregnancy

Concluded

United States

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

Concluded

US & Non-US

P1010

(10814)

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

Concluded

United States

P1008

(10264)

An Observational Study to Determine the Rate of OI Events in HIV-Infected Children Who Have Demonstrated Immunologic Reconstitution While on Stable, Antiretroviral Therapy and Have Discontinued Previously Administered OI Prophylactic Regimens

Participants Off Study and Primary Analysis Completed

Not Applicable

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

P1005

(10314)

A Phase I/II Study of T-20, A Fusion Inhibitor, in HIV-1 Infected Children

Concluded

Not Applicable

IMPAACT 2021

(38530)

Randomized Phase I/II Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV delta NS2/delta 1313/I1314L, RSV delta 6120/NS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age

In Development

United States

IMPAACT 2018

(38405)

Randomized Phase I Study of the Infectivity, Safety, and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV delta NS2/delta 1313/I1314L or RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age

Enrolling

United States

IMPAACT 2017

(30070)

Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents

Pending

United States

IMPAACT 2014

(34150)

Phase I/II Study of the Pharmacokinetics, Safety and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-infected Children and Adolescents

Enrolling

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

Closed to Follow Up

United States

IMPAACT 2007

(20734)

Phase I Safety and Pharmacokinetics of Maraviroc in HIV-1-Exposed Neonates at Risk of Acquiring HIV-1 Infection

Enrolling

US & Non-US

ACTG 954

(10323)

A substudy of ACTG 254: PK Interaction Study for ACTG 254

Concluded

Not Applicable

ACTG 844

(10320)

A Substudy of ACTG 247 to evaluate lean body mass

Concluded

Not Applicable

ACTG 836

(10318)

ACTG 836 is a Substudy of ACTG 265: Cell Mediated Immune Function in a Subgroup of Immunized Patients

Concluded

Not Applicable

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

Concluded

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 366

(10308)

A Phase I/II Master Protocol of Novel Antiretroviral Combination Therapies in Antiretroviral Experienced Children with Rapidly Progessing or Advanced HIV Disease (RAD)

Concluded

Not Applicable

ACTG 353

(10255)

A Phase I Trial of the Safety and Pharmacokinetics of Oral Nelfinavir (Viracept) Co-Administered with ZDV and 3TC in HIV Seropositive Pregnant Women and Their Infants

Concluded

Not Applicable

ACTG 338

(0)

A Phase II Rolling Arm Master Protocol (PRAM) of Novel Anti-Retroviral Therapy in Stable Experienced HIV-Infected Children

Concluded

Not Applicable

ACTG 331

(10305)

The Safety, Tolerance and Pharmacokinetics of Zidovudine in Premature Infants Exposed to HIV

Concluded

Not Applicable

ACTG 316

(0)

A Phase III Randomized, Double Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women

Concluded

Not Applicable

ACTG 300

(0)

A Randomized Comparative Study of Combined Zidovudine-Lamivudine (3TC) vs the Better of ddI Monotherapy vs Zidovudine Plus ddI in Symptomatic HIV-1 Infected Children

Concluded

Not Applicable

ACTG 273

(0)

A Phase I/II Study of HIVIG in Slowing Progression of Disease in HIV-Infected Children

Concluded

Not Applicable

ACTG 265

(10251)

Phase I/II Study of Safety and Immunogenicity of Live-Attenuated Varicella Vaccine (Varivax) in HIV-Infected Children

Concluded

Not Applicable

ACTG 255

(0)

Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated with Zidovudine

Concluded

Not Applicable

ACTG 254

(10301)

Rand Phase II/III, Two-Armed Study of Micronized-Atovaquone and Azithromycin (AT/AZ) as Compared to (TMP/SMX) in the Prevention of Serious Bacterial Infections When Used in Children Aged 2-19 Years with HIV Infection

Concluded

Not Applicable

ACTG 250

(0)

Phase I Study of the Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Pregnant Women

Concluded

Not Applicable

ACTG 245

(10249)

A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents with Advanced HIV Disease

Concluded

Not Applicable

ACTG 240

(0)

A Randomized Comparative Trial of Zidovudine (ZDV) Versus 2'3'-Didehydro-3'-Deoxythymidine (d4T) in Children with HIV Infection

Concluded

Not Applicable

ACTG 235

(0)

Active Immunization of HIV-1 Infected, Pregnant Women, with CD4 Lymphocyte Counts >/= 400/mm3: A Phase 1 Study of Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine

Concluded

Not Applicable

ACTG 230

(10299)

A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV Infected Mothers

Concluded

United States

ACTG 226

(10298)

A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-infected Children with Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease

Concluded

Not Applicable

ACTG 225

(10297)

A Phase II Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the AIDS Clinical Trials Group

Concluded

Not Applicable

ACTG 220

(0)

A "Pre-Enrollment" Protocol for HIV Infected Adolescents

Concluded

Not Applicable

ACTG 219C

(10035)

Pediatric Late Outcomes Protocol

Concluded

Not Applicable

ACTG 218

(0)

A Placebo Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old with Asymptomatic HIV Infection

Concluded

Not Applicable

ACTG 190

(0)

A Phase II Study to Evaluate Pharmacokinetics, Safety, Tolerance and Activity of Dideoxycytidine (ddC) Administered in Combination with Zidovudine (ZDV) in Stable, ZDV-Treated, Pediatric Patients with HIV Infection

Concluded

Not Applicable

ACTG 185

(10296)

A Phase III Randomized, Double-Blind Controlled Study of the Use of HIVIG for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women Receiving Zidovudine

Concluded

Not Applicable

ACTG 179

(0)

Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection

Concluded

Not Applicable

ACTG 153

(0)

Safety, and Tolerance of Zidovudine and Interferon-Alpha-2A in HIV-Infected Children

Concluded

Not Applicable

ACTG 152

(0)

Randomized Comparative Trial of Zidovudine (ZDV) Versus 2'3'Dideoxyinosine (ddI) Versus ZDV Plus ddI in Symptomatic HIV-Infected Children

Concluded

Not Applicable

ACTG 144

(0)

Randomized Comparative Trial of Two Doses of 2'3'-Dideoxyinosine (ddI) in Children with Symptomatic HIV Infection Who are Either Unresponsive to Zidovudine and/or Who are Intolerant to Zidovudine

Concluded

Not Applicable

ACTG 138

(0)

A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children with Symptomatic HIV Infection Who are Intolerant of Zidovudine and/or Show Progressive Disease while on Zidovudine

Concluded

Not Applicable

ACTG 128

(0)

A Randomized Blinded Trial to Evaluate the Safety and Tolerance of High Versus Low Dose Zidovudine Administered to Children with Human Immunodeficiency Virus

Concluded

Not Applicable

ACTG 082

(0)

A Phase I Trial to Evaluate AZT in HIV-1 Infected Pregnant Women and Their Offspring and a Phase I Pharmacokinetic and Safety Trial of AZT in Laboring Women and Their Offspring

Concluded

Not Applicable

ACTG 076

(0)

A Phase III Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerance of Zidovudine for the Prevention of Maternal-Fetal HIV Transmission

Concluded

Not Applicable

ACTG 051

(0)

A Double-Blind, Placebo-Controlled Trial to Evaluate IVIG in Children with Symptomatic HIV Infection Receiving AZT

Concluded

Not Applicable

A5241

(10395)

The Optimized Treatment that Includes or Omits NRTIs (OPTIONS) Trial: A Randomized Strategy Study for HIV-1-Infected Treatment-Experienced Subjects Using the cPSS to Select an Effective Regimen

Participants Off Study and Primary Analysis Completed

United States

1077HS

(10779)

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

Participants Off Study and Primary Analysis Completed

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.