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Studies

 

Studies in Development

  Study Number
(DAIDS ID)
Study Title Study Restriction  

P1108

(11884)

A Phase I/II, Open-Label, Single Arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Anti-Mycobacterial Activity of Bedaquiline in Combination with Multi-Drug Resistant Tuberculosis (MDR-TB) Therapy for the Treatment of HIV-Uninfected and Infected Children and Adolescents with MDR-TB Disease

Non-US

Ongoing Studies

  Study Number
(DAIDS ID)
Study Title Study Status Study Restriction  

IMPAACT 2000

(12016)

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

Pending

United States

P1115

(11954)

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

Open

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

Enrolling

United States

P1113

(11911)

Phase I/II, Safety and Immunogenicity Study of a Recombinant Protein Tuberculosis Vaccine (AERAS-404) in BCG-Primed Infants

Enrolling

Non-US

P1112

(11903)

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

Open

United States

P1111

(11902)

A Phase I/II, Open-Label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Rilpivirine in Antiretroviral Naïve HIV-1 Infected Children, < 12 Years of Age

Pending

US & Non-US

P1110

(11891)

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

Enrolling

US & Non-US

P1107

(11883)

Cord Blood Transplantation using CCR5¿32 Donor Cells for the Treatment of HIV and Underlying Disease

Open

United States

P1106

(11882)

Pharmacokinetic characteristics of antiretrovirals and tuberculosis medicines in low birth weight infants

Pending

Non-US

P1104s

(11878)

A Longitudinal Developmental and Neuropsychological Assessment of the P1060 Clinical Trial Cohorts and Perinatally HIV-Exposed but Uninfected Controls

Enrolling

Non-US

P1102

(10619)

Strategic Timing of AntiRetroviral Treatment

Enrolling

United States

P1101

(11831)

Phase I/II Dose-Finding, Safety, Tolerance, Drug-Drug Interaction and Pharmacokinetics Study of a Raltegravir-Containing Antiretroviral Therapy (ART) Regimen in ART-Naïve HIV-Infected and TB Co-Infected Infants and Children >= 3 Years to 12 Years of Age

Open

Non-US

P1100

(11801)

A Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Immunogenicity of AERAS-402 in BCG-vaccinated, HIV-uninfected Infants Without Evidence of Tuberculosis

Closed to Accrual

Non-US

P1097

(11790)

Raltegravir pharmacokinetics and safety in neonates

Open

United States

P1094

(11769)

Evaluation of 3TC or FTC Monotherapy Compared to Continuing HAART as a Bridging Antiretroviral Strategy in Persistently Non-Adherent Children, Adolescents, and Young Adults Who Are Failing HAART and Have the M184V Resistance Mutation

Closed to Follow Up

US & Non-US

P1093

(11773)

Phase I/II, multi-center, open-label, pharmacokinetic, safety, tolerability and antiviral activity of GSK1349572 a novel integrase inhibitor, in combination regimens in HIV-1 infected infants, children and adolescents

Enrolling

US & Non-US

P1092

(11689)

Evaluation of the steady state pharmacokinetics of zidovudine,lamuvidine,nevirapine and lopinavir/ritonavir in severely malnourished HIV-1-infected antiretrovrial naive children who are initiating HAART

Pending

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

P1085

(10826)

Duration of Human Papilloma Virus (HPV) Type-Specific Antibody After Administration of Quadrivalent HPV Vaccine to HIV-infected Children

Closed to Follow Up

United States

P1083

(10787)

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

Closed to Follow Up

US & Non-US

P1081

(10770)

A Randomized Trial to Evaluate the Virologic Response and Pharmacokinetics of Three Different Potent Regimens in HIV-infected Women Initiating HAART Between 28 and 36 Weeks of Pregnancy for the Prevention of Mother-to-Child Transmission

Enrolling

US & Non-US

P1080

(10768)

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

Enrolling

United States

P1079

(10765)

Pharmacology of Artemisinin-Based Antimalarial Therapy Within the Context of Antiretroviral Therapy

Closed to Follow Up

Non-US

P1078

(10732)

A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety (hepatotoxicity) of Immediate (Antepartum-initiated) Vs Deferred (Postpartum-initiated) Isoniazid Preventive Therapy Among HIV-infected Women in High TB Incidence Settings

Enrolling

Non-US

P1076

(10669)

Impact of Oral Alendronate Therapy on Bone Mineral Density in HIV-Infected Children and Adolescents with Low Bone Mineral Density at Baseline

Closed to Accrual

United States

P1074

(10660)

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

Closed to Accrual

United States

P1073

(10655)

Study of Immune Reconstitution Inflammatory Syndrome (IRIS) for International Sites Initiating Highly Active Antiretroviral Therapy (HAART) in Infants and Children < 72 Months of Age

Closed to Follow Up

Non-US

P1072

(10638)

Safety and immunogenicity of a live, attenuated, rotavirus vaccine (RotaTeqTM) in HIV-infected and uninfected children born to HIV-infected mothers

Closed to Follow Up

Non-US

P1070

(10633)

Dose Finding and Pharmacogenetic Study of EFV in HIV-Infected and HIV/TB Co-infected Infants &amp; Children

Enrolling

US & Non-US

P1068S

(10661)

P1060 Substudy Comparing Differences in Malaria Parasitemia by Real-Time Quantitative PCR in HIV-Infected Infants and Children on PI-Based HAART Versus NNRTI-Based HAART

Closed to Follow Up

US & Non-US

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 Accrual

US & Non-US

P1065

(10396)

Phase I/II Study of Safety and Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in HIV-Infected Youth (Versions 10 - 30) and Open Label Immunogenicity Study of a Booster Dose of MCV4 in Previously Immunized HIV-Infected Children and Youth (Version 40)

Closed to Follow Up

United States

P1063

(10167)

Phase I/II dose-finding investigation of the pharmacokinetics and safety of atorvastatin for treatment of PI-associated increased LDL-cholesterol in HIV-infected children and adolescents

Closed to Accrual

United States

P1060

(10166)

Phase II, Parallel, Randomized Clinical Trials Comparing the Responses to Initiation of NNRTI-Based Versus PI-Based Antiretroviral Therapy in HIV-Infected Infants Who Have and Have Not Previously Received Single-Dose Nevirapine for Prevention of Mother-to-Child HIV Transmission

Closed to Accrual

US & Non-US

P1058A

(10809)

Intensive Pharmacokinetic Studies of New Classes of Antiretroviral Drug Combinations in Children, Adolescents, and Young Adults

Closed to Follow Up

United States

P1045

(10108)

Prevalence Of Morphologic And Metabolic Abormalities In Vertically HIV Infected And Uninfected Children And Adolescents

Closed to Follow Up

United States

P1041

(10047)

A Randomized Double Blind Placebo Controlled Trial to Determine the Efficacy of Isoniazid in preventing Tuberculosis Disease and Latent Tuberculosis Infection among Infants with Perinatal exposure to HIV

Closed to Follow Up

Non-US

P1036B

(10044)

Directly Observed Therapy in HIV-Infected Adolescents

Closed to Follow Up

United States

P1036A

(10193)

Directly Observed Therapy in HIV-Infected Adolescents: Part A - Focus Groups

Closed to Follow Up

United States

P1031A

(10042)

Mother Infant Rapid Intervention At Delivery (MIRIAD) International Version

Closed to Follow Up

US & Non-US

P1026S

(10040)

Pharmacokinetic Properties of Antiretroviral Therapy during Pregnancy

Enrolling

US & Non-US

P1025

(10039)

Perinatal Core Protocol

Closed to Follow Up

United States

P1020A

(10037)

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

Closed to Accrual

US & Non-US

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

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

Closed to Follow Up

United States

PROMISE Studies

  Study Number
(DAIDS ID)
Study Title Study Status Study Restriction  

P1084s

(10790)

Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of PROMISE

Closed to Accrual

Non-US

1077HS

(10779)

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

Enrolling

US & Non-US

1077FF

(10778)

Formula feeding Version of the PROMISE Study

Closed to Accrual

Non-US

1077BF

(10777)

Breastfeeding Version of PROMISE Study

Enrolling

Non-US

Completed Studies

  Study Number
(DAIDS ID)
Study Title Study Status Study Restriction  

P1096

(11796)

Phase 1 Study to Determine the Safety, Infectivity, and Tolerability of 2 Doses of Live Attenuated Recombinant Cold-passaged (cp) 45 Human Parainfluenza Type 3 Virus Vaccine, rHPIV3cp45, Lot PIV3#102A, Delivered as Nose Drops to HPIV3-Seronegative Infants and Children 6 to 36 Months of Age, at a 6 Month Interval

Patients off Study & Primary Analysis Complete

United States

P1089

(11670)

A Laboratory Study to Assess the Immunogenicity of Three Licensed Influenza A (H1N1) 2009 Monovalent Vaccines in HIV-1 Perinatally Infected Children and Youth

Patients off Study & Primary Analysis Complete

United States

P1088

(10840)

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

Concluded

United States

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

P1071

(10634)

Phase I/II Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Vicriviroc (SCH-417690) a novel CCR5 Antagonist in combination regimens in Antiretroviral Therapy Experienced Children and Adolescents

Concluded

Non-US

P1069

(10620)

A Phase I/II Comparative Pharmacokinetic Study of The Fixed-Dose Combination (FDC) of Zidovudine (ZDV), Lamivudine (3TC) and Nevirapine (NVP) as GPO-VIR¿ Z30 Pediatric Tablets versus the Individual Liquid Formulations in HIV-Infected Children 5 mns-13 yr

Concluded

US & Non-US

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

P1059

(10051)

A Phase I Open Label Study to Evaluate the Safety & Tolerability of Recombinant Vaccines in HIV-Infected Young Adults with Good Control of HIV-1 Replication and on Stable Highly Active Antiretroviral Therapy

Concluded

United States

P1057

(10270)

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

Patients off Study & Primary Analysis Complete

Not Applicable

P1056

(10139)

Phase I/II Comparative Pharmacokinetic Study of the Fixed Dose Combination (FDC) of Stavudine (d4T), Lamivudine (3TC) and Nevirapine (NVP) as GPO-VIR® Pediatric Chewable Tablets Versus the Individual Liquid Formulations in HIV-Infected Children > 6 Months to < 13 Years of Age in Thailand

Concluded

US & Non-US

P1055

(10049)

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

Patients off Study & Primary Analysis Complete

United States

P1054

(10138)

Assessment Of Safety And Toxicity Among Infants Born To HIV-Infected Women Enrolled In Antiretroviral Treatment Protocols In Diverse Areas Of The World

Concluded

US & Non-US

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

P1052

(10194)

Abacavir Pharmacokinetics During Chronic Therapy in HIV-1 Infected Adolescents and Young Adults

Patients off Study & Primary Analysis Complete

United States

P1051

(10109)

A Multiple Dose, Open Label, Randomized, Safety and Pharmacokinetic Study of Tipranavir in Combination with Low Dose Ritonavir in HIV-Infected Pediatric Patients

Patients off Study & Primary Analysis Complete

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

P1043

(10048)

Phase III Randomized Trial of the Safety and Efficacy of Three Neonatal Antiretroviral Regimens for Preventions of Intrapartum HIV-1 Transmission

Concluded

Not Applicable

P1042S

(10107)

Cognitive, Behavioral, and Psychosocial Correlates of Medication Adherence in Children and Adolescents with HIV-1 Infection

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

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

P1032

(10137)

Phase II Study of the Pharmacokinetics of Nevirapine and the Incidence of Nevirapine Resistance Mutations in HIV-Infected Women Recieving a Single Intrapartum Dose of Nevirapine Alone or in Combination with ZDV/ddI or ZDV/ddI/LPV/r

Concluded

US & Non-US

P1030

(10041)

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

Concluded

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

P1021

(10038)

An Open-Label Study to Evaluate the Safety, Tolerance, Antiviral Activity and Pharmacokinetics of Emtricitabine in Combination with Efavirenz and Didanosine in a Once-Daily Regimen in HIV-Infected Antiretroviral-Naïve or Very Limited Antiretroviral-Exposed Pediatric Subjects

Patients off Study & Primary Analysis Complete

United States

P1018

(10268)

Single Dose Pharmacokinetic Study of Abacavir in HIV-Infected Children and Adolescents

Patients off Study & Primary Analysis Complete

Not Applicable

P1017

(10317)

Safety, Tolerability, and Antiviral Pharmacodynamics of PEG-Intron in HIV-1 Infected Children

Concluded

Not Applicable

P1015

(10267)

Intensification of HIV-Specific CD4 and CD8 Activity by Cycling Highly Active Antiretroviral Therapy (HAART) in Pediatric/Adolescent Patients with < 50 HIV RNA copies/mL

Patients off Study & Primary Analysis Complete

Not Applicable

P1013

(10191)

A Phase I/II Trial of Ritonavir and Indinavir In Children Failing Other Antiretroviral Therapy

Patients off Study & Primary Analysis Complete

Not Applicable

P1012

(10266)

Phase 1 Pharmacokinetic Study of Once Versus Twice Daily Zidovudine And Lamivudine

Patients off Study & Primary Analysis Complete

Not Applicable

P1011

(10316)

A Randomized, Open-label, Dose-Finding Study with Serostim, Mammalian Cell-Derived Recombinant Human Growth Hormone in Children with HIV-Associated Growth Failure

Concluded

United States

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

Patients off Study & Primary Analysis Complete

Not Applicable

P1007

(10315)

High-Dose Multi-Drug Antiretroviral Salvage Therapy for Heavily Pretreated End Stage Patients - A Phase I Proof of Concept Trial

Concluded

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

Patients off Study & Primary Analysis Complete

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

P1002s

(10312)

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

Concluded

Not Applicable

ATN 052

(10368)

Population Genetics and Immune Response to Hepatitis B Vaccination in Adolescents: A Substudy of ATN 024 and ATN 025: A Substudy of ATN 024 and ATN 025

Concluded

Not Applicable

ATN 023B

(10475)

Typology of Adherence in Adolescents: Phase II

Concluded

United States

 

Department of Health and Human ServicesNational Institutes of Health

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.