Studies Implemented by Texas Childrens Hosp. CRS

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

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

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

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

P1002s

(10312)

Intensive Pharmacokinetic Substudy of Saquinavir Soft-Gelatin Capsules Plus Nelfinavir Administered as a Twice-Daily Regimen

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

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

Participants Off Study and Primary Analysis Completed

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

Closed to Accrual

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 883

(10321)

The Effects of MMR Vaccination on Viral Load in HIV-Infected Children

Concluded

Not Applicable

ACTG 844

(10320)

A Substudy of ACTG 247 to evaluate lean body mass

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 727

(0)

ACTG 727 is a Substudy of ACTG 377: Immunology Substudy of DTaP Vaccine Given to Children 2-9 Years of Age with Negative Tetanus Antibody Titers in ACTG 377

Concluded

Not Applicable

ACTG 725

(0)

ACTG 725 is a Pharmacokinetic Substudy of Nelfinavir Tablets Given to Children < 30 kg in ACTG 377

Concluded

Not Applicable

ACTG 397

(10310)

Randomized Trial of Two Saquinavir-Containing Combination Treatment Regimens in Children 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 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 327

(0)

Trial of Stavudine (d4T) Plus Didanosine (ddI) in Children On Long-Term d4T Monotherapy, and d4T vs d4T + ddI in Children on Long-Term ZDV Monotherapy: Rollover Protocol for ACTG 240 Participants and Children Receiving Prescription ZDV

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 299

(10303)

Phase I/II Trial of Recombinant Interleukin 2 in Symptomatic Human Immunodeficiency Virus-Infected Children

Concluded

United States

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 274

(0)

A Phase I Study of Combination Therapy with Didanosine (ddI) and Ribavirin in HIV-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 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 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 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 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 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 211

(0)

Phase I/II Study of Recombinant Human Interferon-Gamma (rIFN-gamma) in HIV-Infected Children

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 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 146

(0)

Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4-Immunoglobulin G (rCD4-IgG) in Seropositive Women During the Last Trimester of Pregnancy and Their Newborns

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 115

(0)

A Phase I Study of the Safety, Tolerance and Pharmacokinetics of Aerosolized Pentamidine and Parenteral Pentamidine in Children with HIV Infection and Suspected Pneumocystis Carinii Pneumonia

Concluded

Not Applicable

ACTG 091

(0)

A Phase I Safety and Pharmacokinetics Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Infants and Children With AIDS or Symptomatic HIV Infection

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

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

Participants Off Study and Primary Analysis Completed

United States

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.