Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV
An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination With Other Antiretroviral Agents in HIV-Infected Pediatric Patients
2 other identifiers
interventional
100
6 countries
14
Brief Summary
The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 2003
June 23, 2001
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Children may be eligible for this study if they:
- Are at least 3 months old and no older than 17 years of age. This is the age the child needs to be at the time they begin the study.
- Are HIV positive.
- Weigh more than 5.5 pounds. A newborn child must have reached at least 38 weeks of gestation.
- Have or have not taken anti-HIV drugs. Those that have not must have a viral load between 5,000 and 500,000 copies/ml at screening. Those that have must have been taking anti-HIV drugs, including lamivudine, for at least 3 months and have a viral load of no more than 400 copies/ml at screening.
- Have a CD4 count of more than 200 cells/mm3.
- Have written consent from parent or guardian.
- Are willing to use effective birth control during the study and for 1 month after the last dose of emtricitabine, if sexually active.
You may not qualify if:
- Children will not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Cannot follow the visit or dosing schedule or are not available for 1 year.
- Have taken experimental drugs or vaccines (except for emivirine and experimental forms of approved drugs) within 30 days of study start.
- Have nerve damage in their arms or legs.
- Have trouble eating or taking drugs.
- Have serious diarrhea within 30 days before study entry.
- Have had any serious illness within 30 days of study screening. Any treatment must have been finished 14 days before study entry.
- Have had an AIDS-related (opportunistic) disease within 12 months of screening.
- Are being treated for tuberculosis.
- Have had pancreatitis.
- Require certain drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
USC School of Medicine / LA County Med Ctr
Los Angeles, California, 90033, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209, United States
Univ of Miami
Miami, Florida, 331016960, United States
New York Hosp / Cornell Med Ctr
New York, New York, 10021, United States
St Luke's - Roosevelt Hosp Ctr
New York, New York, 10025, United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794, United States
Fundacion HUES
Buenos Aires, Argentina
Instituto Mexicano de Investigacion Clinica
Colonia Roma, Mexico
Hospital del Nino
Panama City, Panama
Univ of Puerto Rico / Med Science Campus
San Juan, 00936, Puerto Rico
Perinatal HIV Research UNIT
Diepkloof, South Africa
Infectious Diseases Clinincal Trial Unit
Gaunteng, South Africa