Studies Implemented by Boston Medical Center Pediatric HIV Program
| Study Number | Study Title | Study Status | Study Restriction |
|---|---|---|---|
|
(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 |
|
(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 |
|
(11891) |
A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-1 Exposed Infants at High Risk |
Participants Off Study and Primary Analysis Completed |
US & Non-US |
|
(11790) |
Raltegravir Pharmacokinetics and Safety in Neonates |
Participants Off Study and Primary Analysis Completed |
United States |
|
(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 |
Closed to Accrual |
US & Non-US |
|
(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 |
|
(10787) |
A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines |
Concluded |
US & Non-US |
|
(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 |
|
(10660) |
A Prospective Surveillance Study of Long Term Outcomes in HIV-infected Infants, Children and Adolescents |
Concluded |
United States |
|
(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 |
Concluded |
US & Non-US |
|
(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 |
|
(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 |
|
(10270) |
A Phase I/II Randomized Trial of the Safety and Immunogenicity of Cold Adapted Influenza Vaccine (FluMist) In HIV-Infected Children |
Concluded |
Not Applicable |
|
(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 |
|
(10108) |
Prevalence of Morphologic and Metabolic Abormalities in Vertically HIV-Infected and Uninfected Children and Adolescents |
Concluded |
United States |
|
(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 |
|
(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 |
|
(10040) |
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum |
Closed to Accrual |
US & Non-US |
|
(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 |
|
(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 |
|
(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 |
|
(10814) |
Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children |
Concluded |
United States |
|
(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 |
|
(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 |
|
(10314) |
A Phase I/II Study of T-20, A Fusion Inhibitor, in HIV-1 Infected Children |
Concluded |
Not Applicable |
|
(38609) |
Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum |
Pending |
US & Non-US |
|
(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 |
Enrolling |
United States |
|
(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 |
Closed to Accrual |
United States |
|
(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 |
Enrolling |
United States |
|
(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 |
Closed to Accrual |
US & Non-US |
|
(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 |
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 |
|
(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 |
|
(10779) |
HAART Standard Version of the PROMISE Study: Promoting Maternal and Infant Survival Everywhere |
Participants Off Study and Primary Analysis Completed |
US & Non-US |