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Early Intensive Antiretroviral Combination Therapy in HIV-1 Infected Infants and Children
This trial tests the safety and effectiveness of the early use of combinations of anti-HIV drugs in HIV-infected infants and young children in an effort to block virus growth and preserve normal immune functions. Various anti-HIV drug combinations need to be tested in order to find the best way to treat infants and children who have been infected with HIV during birth.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 55 |
| Completion | 2005-01 |
Conditions
- HIV Infections
Interventions
- Abacavir sulfate
- Nelfinavir mesylate
- Nevirapine
- Lamivudine
- Stavudine
- Zidovudine
Primary outcomes
- Antiretroviral activity of ZDV/3TC/NVP — Throughout study
- Durability of viral suppression — Throughout study
- Immune competence and HIV-1 specific immune respones with prolonged viral suppression beyond 104 weeks — Throughout study
- Antiretroviral activity of ZDV/3TC/NVP/1592U89 regimen — Throughout study
- Antiretroviral activity of d4T/3TC/NVP/NFV regimen — Throughout study
- Tolerance and pharmacokinetic profile of NFV — Throughout study
Countries
United States