Studies Implemented by University of Miami Pediatric/Perinatal HIV/AIDS

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 VRC01, a Potent Anti-HIV Neutralizing Monoclonal Antibody, in HIV-1 Exposed Infants

Enrolling

US & Non-US

P1097

(11790)

Raltegravir Pharmacokinetics and Safety in Neonates

Enrolling

United States

P1093

(11773)

Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of GSK1349572 (Dolutegravir), a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents

Enrolling

US & 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

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

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 Follow Up

US & Non-US

P1074

(10660)

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

Closed to Follow Up

United States

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

Closed to Follow Up

United States

P1036A

(10193)

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

Concluded

United States

P1026S

(10040)

Pharmacokinetic Properties of Antiretroviral Therapy during Pregnancy

Enrolling

US & Non-US

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

Pending

US & Non-US

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

Participants Off Study and Primary Analysis Completed

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 369

(10033)

A Phase I/II Study of Nitazoxanide for the treatment of cryptosporidiosis in infants, children and adolescents with HIV infection

Concluded

Non-US

ACTG 219C

(10035)

Pediatric Late Outcomes Protocol

Participants Off Study and Primary Analysis Completed

Not Applicable

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

1077HS

(10779)

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

Closed to Follow Up

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.