Studies Implemented by UCSD Mother-Child-Adolescent 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

P1114

(11948)

A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV cps2, Lot RSV#005A, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age

Concluded

United States

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

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

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

P1026S

(10040)

Pharmacokinetic Properties of Antiretroviral Therapy during Pregnancy

Enrolling

US & Non-US

P1009

(0)

Mononuclear Cell Phenotyping in Normal Children

Concluded

Not Applicable

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

P1004s

(10313)

Intensive PK substudies in ACTG 403

Concluded

Not Applicable

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 2015

(35123)

Evaluation of the HIV-1 Reservoir in the Central Nervous System of Perinatally-Infected Youth and Young Adults with Cognitive Impairment

Open to Accrual

United States

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 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

Participants Off Study and Primary Analysis Completed

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

Participants Off Study and Primary Analysis Completed

United States

IMPAACT 2008

(20735)

Phase I/II Multisite, Randomized, Controlled Study of Monoclonal Antibody VRC01 with Combination Antiretroviral Therapy to Promote Clearance of HIV-1-Infected Cells in Infants

Enrolling

US & Non-US

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

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

IMPAACT 2000

(12016)

A Phase I Study of the Safety and Immunogenicity of Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV LID delta M2-2 in RSV-Seronegative Infants and Children

Concluded

United States

ACTG 954

(10323)

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

Concluded

Not Applicable

ACTG 953

(10322)

Nested Study: Follow patients who have CD4 counts less than 50 and are taking MAC prophylaxis

Concluded

Not Applicable

ACTG 949

(0)

ACTG 949 is a nested study of ACTG 249: Neonatal Pharmacokinetics of Didanosine (ddI)

Concluded

Not Applicable

ACTG 843

(0)

ACTG 843 is the Virology Substudy of ACTG 300 This substudy will attempt to corolate disease progression with drug resistance in a subset of ACTG 300 subjects

Concluded

Not Applicable

ACTG 707

(0)

Durability of Cell-Mediated and Humoral Immune Responses to Vaccine Antigens in Children Born to HIV-Infected Mothers: A Substudy of ACTG 230

Concluded

Not Applicable

ACTG 403

(10311)

Randomized, Multicenter Protocol Evaluating Two Antiretroviral Regimens Containing Combinations of Protease Inhibitors, NRTIs and NNRTI

Concluded

Not Applicable

ACTG 397

(10310)

Randomized Trial of Two Saquinavir-Containing Combination Treatment Regimens in Children with HIV Infection

Concluded

Not Applicable

ACTG 395

(10262)

A Multicenter, Open-Label, 48 Week Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Indinavir in Combination with Stavudine and Lamivudine in Patients with HIV Infection

Concluded

Not Applicable

ACTG 394

(10034)

A Phase I Study of the Safety, Tolerance, and Pharmacokinetics of Tenofovir Disoproxil Fumarate (TDF) and the Combination of TDF plus Emtricitabine in HIV-I Infected Pregnant Women and Their Infants

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 377

(10309)

A Phase I/II Randomized, Multicenter Protocol Comparing Four Antiretroviral Regimens Containing Combinations of Protease Inhibitors, NRTIs and an NNRTI

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 358

(10258)

A Phase I Trial of the Safety, Tolerance and Pharmacokinetics of Oral Indinavir Co-Administered with ZDV and 3TC in HIV-1 Infected Pregnant Women During Gestation and Post Partum, and in their Infants Post Maternal Dosing

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 345

(10307)

Phase I/II Study of Ritonavir in HIV-1 Infected Infants and Children

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 330

(0)

A Phase I Safety and Pharmacokinetic Study of 1592U89 Alone and in Combination with Other Antiretroviral Agents in Infants and Children with HIV Infection

Concluded

Not Applicable

ACTG 324

(10252)

A Phase I Trial of the Pharmacokinetics and Tolerance of Oral Zidovudine Administered to HIV-1 Infected Pregnant Women During Labor and Delivery

Concluded

Not Applicable

ACTG 321

(10304)

Phase I Study of Safety, Tolerance, and Pharmacokinetics of 1592U89 with Standard Zidovudine (ZDV) Therapy in Neonates Born to HIV-1 Infected Women

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 292

(10302)

A Double Blind, Placebo Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants

Concluded

Not Applicable

ACTG 288

(0)

Follow-up of Women Participating in ACTG 076

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 249

(10300)

A Phase I Trial to Evaluate Didanosine (ddI) in 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 239

(0)

A Phase I Evaluation of the Safety and Toxicity of ZDV and DDI in Combination in HIV-Infected or Exposed Infants, and a Phase II Study of the Effect of DDI Alone Vs ZDV/DDI Combo on HIV RNA in Infants with HIV Infect

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 219C

(10035)

Pediatric Late Outcomes Protocol

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 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 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 052

(0)

A Multicenter Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Oral AZT in the Treatment of Children Infected with HIV with Mild to Moderate Symptoms (Including LIP)

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

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.