Studies Implemented by Chiang Mai University HIV Treatment (CMU HIV Treatment) 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

P1091

(11687)

Administration of Polysaccharide or Conjugate Pneumococcal Vaccines to HIV-Infected Pregnant Women: Safety, Immunogenicity, and Transplacental Transfer and Persistence of Anti-Pneumococcal Antibodies

Withdrawn

Non-US

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

Temporarily Closed

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

P1026S

(10040)

Pharmacokinetic Properties of Antiretroviral Therapy during Pregnancy

Enrolling

US & Non-US

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

Pending

US & 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.