Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2003 by NIH AIDS Clinical Trials Information Service.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Triangle Pharmaceuticals
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00017992
First received: June 23, 2001
Last updated: June 23, 2005
Last verified: March 2003
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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 2 |
| 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 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
| 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 (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017992
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017992
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 | |
| New York Hosp / Cornell Med Ctr | Active, not recruiting |
| New York, New York, United States, 10021 | |
| St Luke's - Roosevelt Hosp Ctr | Active, not recruiting |
| New York, New York, United States, 10025 | |
| 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 | |
Sponsors and Collaborators
Triangle Pharmaceuticals
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 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
HIV-1 Drug Administration Schedule Stavudine HIV Protease Inhibitors Ritonavir |
Reverse Transcriptase Inhibitors Anti-HIV Agents Pharmacokinetics ABT 378 emtricitabine |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Stavudine Emtricitabine |
Anti-Retroviral Agents Reverse Transcriptase Inhibitors HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors Antimetabolites |
ClinicalTrials.gov processed this record on September 30, 2016