Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV

Status unconfirmed · Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.

Key facts

Study ID

NCT00017992

Run by

Triangle Pharmaceuticals

People needed

100

Last updated by the study team

2005-06-24

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Perinatal HIV Research UNIT — Diepkloof, South Africa (enrolling)
• Infectious Diseases Clinincal Trial Unit — Gaunteng, South Africa (enrolling)
• Univ of Miami — Miami, Florida, United States
• New York Hosp / Cornell Med Ctr — New York, New York, United States
• St Luke's - Roosevelt Hosp Ctr — New York, New York, United States
• State Univ of New York at Stony Brook — Stony Brook, New York, United States
• Bronx Municipal Hosp Ctr/Jacobi Med Ctr — The Bronx, New York, United States
• USC School of Medicine / LA County Med Ctr — Los Angeles, California, 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, Puerto Rico
• Saint Jude Children's Research Hosp of Memphis — Memphis, Tennessee, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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