Clinical trial NCT00017992: Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV
Official title: An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination With Other Antiretroviral Agents in HIV-Infected Pediatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV-1
Drug Administration Schedule
Stavudine
HIV Protease Inhibitors
Ritonavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Pharmacokinetics
ABT 378
emtricitabine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Detailed description: Children are placed into 1 of 4 treatment groups based on age: Group 1, 3 months to 24 months; Group 2, 25 months to 6 years; Group 3, 7 years to 12 years; Group 4, 13 years to 17 years. They receive baseline evaluations. Antiretroviral-naive patients receive emtricitabine plus stavudine plus lopinavir/ritonavir. Antiretroviral-experienced patients replace lamivudine with emtricitabine. Patients return to the clinic for follow-up visits at Weeks 2 and 4 and then every 4 weeks until Week 48. Safety is evaluated using adverse events, which are reviewed at every clinic visit. Clinical laboratory data and full-profile pharmacokinetics of emtricitabine are evaluated at some visits. After the Week 48 study evaluations are completed, individual patients may continue to receive study medication (as provided by the sponsor) until commercially available, if certain criteria are met.

Eligibility criteria: Inclusion Criteria

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.

Exclusion Criteria

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC School of Medicine / LA County Med Ctr
state: California
city: Jacksonville
country: United States
facility: Univ of Florida Health Science Ctr / Pediatrics
state: Florida
city: Miami
country: United States
facility: Univ of Miami
state: Florida
city: Bronx
country: United States
facility: Bronx Municipal Hosp Ctr/Jacobi Med Ctr
state: New York
city: New York
country: United States
facility: New York Hosp / Cornell Med Ctr
state: New York
city: New York
country: United States
facility: St Luke's - Roosevelt Hosp Ctr
state: New York
city: Stony Brook
country: United States
facility: State Univ of New York at Stony Brook
state: New York
city: Memphis
country: United States
facility: Saint Jude Children's Research Hosp of Memphis
state: Tennessee
city: Buenos Aires
country: Argentina
facility: Fundacion HUES
city: Col Roma
country: Mexico
facility: Instituto Mexicano de Investigacion Clinica
city: Panama City
country: Panama
facility: Hospital del Nino
city: San Juan
country: Puerto Rico
facility: Univ of Puerto Rico / Med Science Campus
city: Diepkloof
country: South Africa
facility: Perinatal HIV Research UNIT
city: Gaunteng
country: South Africa
facility: Infectious Diseases Clinincal Trial Unit
Study officials:
References: