Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

August 31, 2001

Primary Completion Date

January 31, 2009

Study Completion Date

January 31, 2009

Conditions
HIV Infections
Interventions
DRUG

Didanosine (ddI)

Antiretroviral Didanosine (ddI) : 240 mg/m\^2 up to a maximum of 400 mg once daily

DRUG

Efavirenz (EFV)

Antiretroviral For Age Group 1 Efavirenz (EFV): dose adjusted for body size and for Age Groups 2 and 3 Efavirenz (EFV): up to a maximum of 600 mg once daily as a capsule ot 720 mg as an oral solution

DRUG

Emtricitabine (FTC)

Antiretroviral Emtricitabine (FTC): 6 mg/Kg up to a maximum of 200 mg once daily

Trial Locations (18)

10016

Nyu Ny Nichd Crs, New York

13210

SUNY Upstate Med. Univ., Dept. of Peds., Syracuse

20060

Howard Univ. Washington DC NICHD CRS, Washington D.C.

32209

Univ. of Florida Jacksonville NICHD CRS, Jacksonville

33161

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

77030

Texas Children's Hosp. CRS, Houston

277103499

DUMC Ped. CRS, Durham

381052794

St. Jude/UTHSC CRS, Memphis

606143394

Chicago Children's CRS, Chicago

802181088

Univ. of Colorado Denver NICHD CRS, Aurora

941430105

UCSF Pediatric AIDS CRS, San Francisco

Unknown

UCSD Maternal, Child, and Adolescent HIV CRS, San Diego

Rush Univ. Cook County Hosp. Chicago NICHD CRS, Chicago

Harlem Hosp. Ctr. NY NICHD CRS, New York

021155724

Children's Hosp. of Boston NICHD CRS, Boston

016550001

WNE Maternal Pediatric Adolescent AIDS CRS, Worcester

009365067

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS, San Juan

009367344

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

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00016718 - Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs | Biotech Hunter | Biotech Hunter