Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Jun 10, 2002

Keywords

ClinConnect Summary

Antiretroviral therapy in children aims to prolong clinical and immunologic health. Currently, there are no data defining a particular highly active antiretroviral therapy (HAART) strategy as the optimal first-line therapy for children. This study evaluated the long-term efficacy of two HAART regimens used as initial therapy: 1) two nucleoside reverse transcriptase inhibitors (NRTIs) plus a protease inhibitor (PI), and 2) two NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI). It also evaluated different strategies for switching therapy when the initial regimen fails. The lo...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Older than 30 days and younger than 18 years of age (may enroll up to the day before their 18th birthday)
• • HIV infected
• • Not previously on HAART or received anti-HIV drugs for less than 56 consecutive days after birth to prevent mother-to-infant HIV transmission. Participants who have previously received nevirapine for the prevention of mother-to-infant HIV transmission are not eligible for this study.
• • Willing to use acceptable methods of contraception
• Exclusion Criteria:
• • Grade 3 or 4 clinical or laboratory toxicity. More information on this criterion can be found in the protocol.
• • Active opportunistic infection or a serious bacterial infection at the time of study entry
• • Pancreas, nervous system, blood, liver, or kidney problems that make it impossible to take study medications
• • Taking any medication that cannot be combined with the study medications in first-line therapy
• • Received therapy for cancer
• • Pregnant or breastfeeding