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| Sponsor: | Triangle Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00017992 |
Purpose
The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Lopinavir/Ritonavir Drug: Emtricitabine Drug: Stavudine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacodynamics Study Primary Purpose: Treatment |
| Official Title: | An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination With Other Antiretroviral Agents in HIV-Infected Pediatric Patients |
| Estimated Enrollment: | 100 |
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| Ages Eligible for Study: | 3 Months to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Children may be eligible for this study if they:
Exclusion Criteria
Children will not be eligible for this study if they:
Contacts and Locations| United States, California | |
| USC School of Medicine / LA County Med Ctr | Active, not recruiting |
| Los Angeles, California, United States, 90033 | |
| United States, Florida | |
| Univ of Florida Health Science Ctr / Pediatrics | Active, not recruiting |
| Jacksonville, Florida, United States, 32209 | |
| Univ of Miami | Active, not recruiting |
| Miami, Florida, United States, 331016960 | |
| United States, New York | |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | Active, not recruiting |
| Bronx, New York, United States, 10461 | |
| St Luke's - Roosevelt Hosp Ctr | Active, not recruiting |
| New York, New York, United States, 10025 | |
| New York Hosp / Cornell Med Ctr | Active, not recruiting |
| New York, New York, United States, 10021 | |
| State Univ of New York at Stony Brook | Active, not recruiting |
| Stony Brook, New York, United States, 117948111 | |
| United States, Tennessee | |
| Saint Jude Children's Research Hosp of Memphis | Active, not recruiting |
| Memphis, Tennessee, United States, 381052794 | |
| Argentina | |
| Fundacion HUES | Active, not recruiting |
| Buenos Aires, Argentina | |
| Mexico | |
| Instituto Mexicano de Investigacion Clinica | Active, not recruiting |
| Col Roma, Mexico | |
| Panama | |
| Hospital del Nino | Active, not recruiting |
| Panama City, Panama | |
| Puerto Rico | |
| Univ of Puerto Rico / Med Science Campus | Active, not recruiting |
| San Juan, Puerto Rico, 00936 | |
| South Africa | |
| Perinatal HIV Research UNIT | Recruiting |
| Diepkloof, South Africa | |
| Contact: Dr. Avy Violari 011+27 11 989 9700 violari@mweb.co.za | |
| Infectious Diseases Clinincal Trial Unit | Recruiting |
| Gaunteng, South Africa | |
| Contact: Pauline Francesca Conradie 011+ 27 11 717 2810 francesca_conradie@witshealth.co.za | |
More Information
| ClinicalTrials.gov Identifier: | NCT00017992 History of Changes |
| Other Study ID Numbers: | 298D, FTC-203 |
| Study First Received: | June 23, 2001 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Drug Administration Schedule Stavudine HIV Protease Inhibitors Ritonavir |
Reverse Transcriptase Inhibitors Anti-HIV Agents Pharmacokinetics ABT 378 emtricitabine |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases HIV Protease Inhibitors Ritonavir Lopinavir |
Stavudine Reverse Transcriptase Inhibitors Emtricitabine Anti-Retroviral Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Antimetabolites Nucleic Acid Synthesis Inhibitors |