feature photo

Studies

       ➤ View Current Study Snapshot

       ➤ Submit a Study Proposal

 

Protocols in Development

  Study Number
(DAIDS ID)
Study Title Study Restriction  

IMPAACT 2026

(TBD)

Pharmacokinetic Properties of Antiretroviral, Anti-Tuberculosis, Contraceptive and Related Drugs During Pregnancy and Postpartum

US & Non-US

IMPAACT 2023

(TBD)

A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Dolutegravir in HIV-1 Exposed Neonates at Risk of Acquiring HIV-1 Infection

US & Non-US

IMPAACT 2022

(TBD)

Phase II Study of the Effectiveness and Feasibility of Long-Acting Injectable Antiretroviral Medications in Non-Adherent HIV-Infected Youth

United States

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 NS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age

United States

IMPAACT 2020

(38505)

Shortened Oral Treatment for Multidrug-Resistant Tuberculosis in Infants, Children and Adolescents (SMaRT Kids): A Phase III Randomized Multi-center Trial

Non-US

Ongoing Studies

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

IMPAACT 2019

(38504)

Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less than 12 Years of Age

Pending

US & Non-US

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 2016

(38506)

Evaluating a Group-Based Intervention to Improve Mental Health and ART Adherence in Adolescents Living with HIV in Low Resource Settings

Pending

Non-US

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 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 2010

(30129)

Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants

Enrolling

US & Non-US

IMPAACT 2009

(30020)

Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention during Pregnancy and Postpartum in Adolescents and Young Women and their Infants

Open to Accrual

Non-US

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 2005

(20721)

A Phase I/II Open-label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination with Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in HIV-infected and HIV-uninfected Children with MDR-TB

Open to Accrual

Non-US

IMPAACT 2003B

(12041)

(Phoenix) Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant TB Patients

Pending

Non-US

IMPAACT 2003/ACTG 5300

(11803)

Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design

Closed to Follow Up

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 2001

(12026)

A Phase I/II Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-1-infected and HIV-1-uninfected Pregnant and Postpartum Women with Latent Tuberculosis Infection

Closed to Accrual

US & Non-US

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

P1113

(11911)

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

Closed to Follow Up

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

P1108

(11884)

A Phase I/II, Open-Label, Single Arm Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Bedaquiline (BDQ) in Combination with Optimized Individualized Multidrug-Resistant Tuberculosis (MDR-TB) Therapy in HIV-Infected and HIV-Uninfected Infants, Children and Adolescents with MDR-TB Disease

Enrolling

Non-US

P1107

(11883)

Cord Blood Transplantation with CCR5delta32 Donor Cells in HIV-1 Infected Subjects who Require Bone Marrow Transplantation for any Indication and Its Observed Effects on HIV-1 Persistence

Enrolling

United States

P1106

(11882)

Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants

Enrolling

Non-US

P1104s

(11878)

Longitudinal Developmental and Neuropsychological Assessments of HIV-Infected Participants of P1060 and HIV-Uninfected Controls

Closed to Follow Up

Non-US

P1102

(10619)

Strategic Timing of AntiRetroviral Treatment

Closed to Accrual

United States

P1101

(11831)

Phase I/II Dose-Finding, Safety, Tolerance and Pharmacokinetics Study of a Raltegravir-Containing Antiretroviral Therapy (ART) Regimen in HIV-infected and TB Co-infected Infants and Children

Enrolling

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

P1092

(11689)

Phase IV Evaluation of the Steady State Pharmacokinetics of Zidovudine, Lamivudine, and Lopinavir/Ritonavir in Severely Malnourished HIV-1 Infected Children

Closed to Follow Up

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

Closed to Accrual

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

P1026S

(10040)

Pharmacokinetic Properties of Antiretroviral Therapy during Pregnancy

Enrolling

US & Non-US

P1025

(10039)

Perinatal Core Protocol

Closed to Follow Up

United States

TIES Study
Observational study of HIV-infected infants in the United States who initiate antiretroviral therapy (ART) at less than 6 weeks of age.
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 Protocol: Promoting Maternal and Infant Survival Everywhere

Closed to Follow Up

Non-US

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

1077FF

(10778)

Formula Feeding Version of the PROMISE Study: Promoting Maternal and Infant Survival Everywhere

Closed to Follow Up

Non-US

1077BF

(10777)

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

Closed to Follow Up

Non-US

Completed Studies

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

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

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

ATN 023B

(10475)

Typology of Adherence in Adolescents: Phase II

Concluded

United States

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

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

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 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

P1002s

(10312)

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

Concluded

Not Applicable

P1004s

(10313)

Intensive PK substudies in ACTG 403

Concluded

Not Applicable

P1005

(10314)

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

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

Concluded

United States

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

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

P1010

(10814)

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

Concluded

United States

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

P1012

(10266)

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

Concluded

Not Applicable

P1013

(10191)

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

Participants Off Study and Primary Analysis Completed

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

Concluded

Not Applicable

P1017

(10317)

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

Concluded

Not Applicable

P1018

(10268)

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

Participants Off Study and Primary Analysis Completed

Not Applicable

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

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

Participants Off Study and Primary Analysis Completed

United States

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

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

P1030

(10041)

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

Concluded

Non-US

P1031A

(10042)

Mother Infant Rapid Intervention At Delivery (MIRIAD) International Version

Concluded

US & Non-US

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

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

P1036A

(10193)

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

Concluded

United States

P1036B

(10044)

Directly Observed Therapy in HIV-Infected Adolescents

Concluded

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

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

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

Participants Off Study and Primary Analysis Completed

Non-US

P1042S

(10107)

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

Concluded

United States

P1043/HPTN 040

(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

P1045

(10108)

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

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

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

Participants Off Study and Primary Analysis Completed

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

Concluded

United States

P1052

(10194)

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

Concluded

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

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

P1055

(10049)

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

Concluded

United States

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

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

P1058A

(10809)

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

Participants Off Study and Primary Analysis Completed

United States

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

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

Participants Off Study and Primary Analysis Completed

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

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

P1065

(10396)

Phase I/II Study of Safety and Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in HIV-Infected Youth (Versions 1.0 - 3.0) and Open Label Immunogenicity Study of a Booster Dose of MCV4 in Previously Immunized HIV-Infected Children and Youth (Version 4.0)

Concluded

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

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

Concluded

US & 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

P1070

(10633)

Dose Finding and Pharmacogenetic Study of EFV in HIV-Infected and HIV/TB Co-infected Infants & Children >=3 months to <36 Months of Age

Participants Off Study and Primary Analysis Completed

Non-US

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

P1072

(10638)

Safety and Immunogenicity of a Live, Attenuated, Rotavirus Vaccine (RotaTeq™) in HIV-1 Infected and Uninfected Children Born to HIV-1 Infected Mothers

Participants Off Study and Primary Analysis Completed

Non-US

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

Participants Off Study and Primary Analysis Completed

Non-US

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

P1076

(10669)

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

Participants Off Study and Primary Analysis Completed

US & Non-US

P1078

(10732)

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

Participants Off Study and Primary Analysis Completed

Non-US

P1079

(10765)

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

Participants Off Study and Primary Analysis Completed

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

P1085

(10826)

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

Participants Off Study and Primary Analysis Completed

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

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

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

Concluded

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

Concluded

US & Non-US

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

Concluded

United States

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

Concluded

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

 

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.