drugset / Trial / NCT00016718
Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs
Phase 1/2
Completed
43 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study was to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who had taken few or no anti-HIV drugs.
Timeline
- Start
- 2001-08
- Primary completion
- 2009-01
- Completion
- 2009-01
Publications
- Background McKinney RE Jr, Cunningham CK. Newer treatments for HIV in children. Curr Opin Pediatr. 2004 Feb;16(1):76-9. doi: 10.1097/00008480-200402000-00014.
- Results Weinberg A, Dickover R, Britto P, Hu C, Patterson-Bartlett J, Kraimer J, Gutzman H, Shearer WT, Rathore M, McKinney R; PACTG 1021 team. Continuous improvement in the immune system of HIV-infected children on prolonged antiretroviral therapy. AIDS. 2008 Nov 12;22(17):2267-77. doi: 10.1097/QAD.0b013e3283189bb3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Didanosine | Small molecule | 240 mg/m2 | Oral |
| Subject | Efavirenz | Other / unclassified | 600 mg | Oral |
| Subject | Efavirenz | Other / unclassified | 720 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 6 mg/kg | Oral |