Studies Implemented by Molepolole Prevention/Treatment Trials CRS

Study Number Study Title Study Status Study Restriction

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

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

Closed to Follow Up

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

Closed to Follow Up

Non-US

P1026S

(10040)

Pharmacokinetic Properties of Antiretroviral Therapy during Pregnancy

Enrolling

US & Non-US

IMPAACT 2016

(TBD)

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

In Development

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

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

Pending

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

Pending

Non-US

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.