Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants

PHASE1CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

March 31, 2004

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2011

Conditions
HIV Infections
Interventions
DRUG

Emtricitabine/Tenofovir disoproxil fumarate

900 mg of TDF combined with 600 mg emtricitabine

DRUG

Tenofovir disoproxil fumarate

600 mg oral dose of TDF

Trial Locations (12)

10016

Nyu Ny Nichd Crs, New York

10457

Bronx-Lebanon Hosp. IMPAACT CRS, The Bronx

20010

Children's National Med. Ctr. Washington DC NICHD CRS, Washington D.C.

Washington Hosp. Ctr. NICHD CRS, Washington D.C.

33136

Univ. of Miami Ped. Perinatal HIV/AIDS CRS, Miami

48201

Children's Hospital of Michigan NICHD CRS, Detroit

60608

Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program, Chicago

07101-1709

NJ Med. School CRS, Newark

19102-1192

Hahnemann Univ. Hosp., Philadelphia

Unknown

Regional Med. Ctr. at Memphis, Memphis

St. Jude/UTHSC CRS, Memphis

San Juan City Hosp. PR NICHD CRS, San Juan

All Listed Sponsors
collaborator

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

NIH

collaborator

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

NETWORK

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00076791 - Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants | Biotech Hunter | Biotech Hunter