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Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV Clinical research trials and Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV. Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV clinical trial. Participants typically obtain the most effective healthcare available for their Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV  Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV
Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): Triangle Pharmaceuticals ,
Synopsis: The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.
Details: 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:
Study Type: Interventional, Treatment, Pharmacodynamics Study
Minimum Age/Maximum Age: 3 Months/17 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 100
Location and Contact Information:
Saint Jude Children's Research Hosp of Memphis *No longer recruiting*
Memphis, Tennessee, 381052794
United States
No longer recruiting
Perinatal HIV Research UNIT *Recruiting*
Diepkloof, ,
South Africa
Recruiting Dr. Violari 011+27 11 989 9700
Bronx Municipal Hosp Ctr/Jacobi Med Ctr *No longer recruiting*
Bronx, New York, 10461
United States
No longer recruiting
Hospital del Nino *No longer recruiting*
Panama City, ,
Panama
No longer recruiting
Univ of Miami *No longer recruiting*
Miami, Florida, 331016960
United States
No longer recruiting
State Univ of New York at Stony Brook *No longer recruiting*
Stony Brook, New York, 117948111
United States
No longer recruiting
Univ of Puerto Rico / Med Science Campus *No longer recruiting*
San Juan, , 00936
Puerto Rico
No longer recruiting
Instituto Mexicano de Investigacion Clinica *No longer recruiting*
Col Roma, ,
Mexico
No longer recruiting
Infectious Diseases Clinincal Trial Unit *Recruiting*
Gaunteng, ,
South Africa
Recruiting Pauline Conradie 011+ 27 11 717 2810
St Luke's - Roosevelt Hosp Ctr *No longer recruiting*
New York City, New York, 10025
United States
No longer recruiting
Univ of Florida Health Science Ctr / Pediatrics *No longer recruiting*
Jacksonville, Florida, 32209
United States
No longer recruiting
New York Hosp / Cornell Med Ctr *No longer recruiting*
New York City, New York, 10021
United States
No longer recruiting
Fundacion HUES *No longer recruiting*
Buenos Aires, ,
Argentina
No longer recruiting
USC School of Medicine / LA County Med Ctr *No longer recruiting*
Los Angeles, California, 90033
United States
No longer recruiting
Additional Information:
Study ID Numbers: 298D; FTC-203
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017992
Other Hiv Infections Studies:
1. Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis
2. The Effectiveness of HIV RNA Viral Load Testing in Determining Treatment Type in HIV-Infected Patients
3. Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids
4. A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
5. A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients with Advanced HIV Infection
Related Studies:
Other HIV Infections Clinical Trials
Other Clinical Trials
Other Buenos Aires Clinical Trials
Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV
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