Safety and Blood Levels of Tenofovir Disoproxil Fumarate in HIV Infected Pregnant Women and Their Babies

PHASE1CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

October 31, 2011

Study Completion Date

December 31, 2011

Conditions
HIV Infections
Interventions
DRUG

Tenofovir disoproxil fumarate

600-mg tablet taken orally once daily

DRUG

Tenofovir disoproxil fumarate

4-mg/kg oral suspension taken at birth and on Days 3 and 5 after birth

DRUG

Tenofovir disoproxil fumarate

6-mg/kg oral suspension taken at birth and daily for 7 days after birth

Trial Locations (5)

Unknown

Federal Univ. of Minas Gerais, Belo Horizonte

Irmandade Santa Casa de Misericórdia de Porto Alegre, Porto Alegre

College of Med. JHU CRS, Blantyre

91350-200

Hospital Nossa Senhora da Conceicao CRS, Porto Alegre

20221-903

HSE-Hospital dos Servidores do Estado CRS, Rio de Janeiro

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

National Institute on Drug Abuse (NIDA)

NIH

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00120471 - Safety and Blood Levels of Tenofovir Disoproxil Fumarate in HIV Infected Pregnant Women and Their Babies | Biotech Hunter | Biotech Hunter