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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00017992
Other study ID # 298D
Secondary ID FTC-203
Status Recruiting
Phase Phase 2
First received June 23, 2001
Last updated June 23, 2005

Study information

Verified date March 2003
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 17 Years
Eligibility 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.

Study Design

Endpoint Classification: Pharmacodynamics Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Lopinavir/Ritonavir

Emtricitabine

Stavudine


Locations

Country Name City State
Argentina Fundacion HUES Buenos Aires
Mexico Instituto Mexicano de Investigacion Clinica Col Roma
Panama Hospital del Nino Panama City
Puerto Rico Univ of Puerto Rico / Med Science Campus San Juan
South Africa Perinatal HIV Research UNIT Diepkloof
South Africa Infectious Diseases Clinincal Trial Unit Gaunteng
United States Bronx Municipal Hosp Ctr/Jacobi Med Ctr Bronx New York
United States Univ of Florida Health Science Ctr / Pediatrics Jacksonville Florida
United States USC School of Medicine / LA County Med Ctr Los Angeles California
United States Saint Jude Children's Research Hosp of Memphis Memphis Tennessee
United States 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

Sponsors (1)

Lead Sponsor Collaborator
Triangle Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Mexico,  Panama,  Puerto Rico,  South Africa, 

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