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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe.

Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); PENTA Foundation

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