When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine when HIV infected children should begin taking anti-HIV medications in order to improve both patient quality of life and survival.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Comprehensive International Program of Research on AIDS
• Treatments: Abacavir; Efavirenz; Lamivudine; Lopinavir; Nelfinavir; Nevirapine; Ritonavir; Zidovudine

Criteria

Inclusion Criteria:

• HIV-1 infected

• Antiretroviral naive, defined as never receiving anti-HIV medications, receiving them for less than 7 days, or only receiving them to prevent mother-to-child transmission (MTCT)

• CD4% between 15 and 24 within 30 days prior to study entry

• CDC pediatric clinical classification A or B

• Parent or guardian willing to provide informed consent and willing to follow all study procedures and requirements

Exclusion Criteria:

• Use of systemic chemotherapy, immunomodulators, HIV vaccines, immune globulin, interleukins, or interferons within 30 days prior to study entry

• Active AIDS-defining illnesses (CDC Category C) within 30 days prior to study entry

• Certain abnormal laboratory values

• Known kidney disease

• Known allergy or sensitivity to study drugs

• Require certain medications

• Pregnancy