Overview

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