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

NCT00234091 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2013-12-04

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

Abacavir

8 mg/kg (up to 300 mg/dose) take orally twice daily

DRUG

Efavirenz

200 to 600 mg taken orally once daily

DRUG

Lamivudine

4 mg/kg (up to 150 mg/dose) taken orally twice daily

DRUG

Lopinavir/Ritonavir

230 mg/57.5 mg/m\^2 body surface area taken orally twice daily with food

DRUG

Nelfinavir

45-55 mg/kg taken orally twice daily with food

DRUG

Nevirapine

120 mg/m\^2 once daily for first 14 days, tehn 200 mg/m\^2 (up to 400 mg/day) twice daily

DRUG

Zidovudine

180-240 mg/m\^2 every 12 hours (up to 300 mg/dose)

Sponsors & Collaborators

  • Comprehensive International Program of Research on AIDS

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Kiat Ruxrungtham, MD, MPH · Department of Medicine at Chulalongkorn University, Bangkok, Thailand

  • Saphonn Vonthanak, MD, PhD · National Center for HIV/AIDS Dermatology and STDs, Phnom Penh, Cambodia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Cambodia
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00234091 on ClinicalTrials.gov