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An Open-Label Study of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects

NCT00642291 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2008-04-10

No results posted yet for this study

Summary

To obtain safety and efficacy data for antiretroviral regimens containing emtricitabine in HIV-1 infected pediatric subjects. To determine emtricitabine concentrations in HIV-1 infected pediatric subjects and, if necessary, to refine the dose of emtricitabine to achieve concentrations comparable to those in adults given 200 mg emtricitabine once-daily.

Conditions

  • HIV Infections

Interventions

DRUG

Emtricitabine

emtricitabine (6mg/kg QD; max 200 mg QD) plus stavudine 1 mg/kg BID (if \<30kg)plus lopinavir/ritonavir (12/3 mg/kg BID if \>=7 to \<15kg; 10/2.5 mg/kg BID if \>=15 to \<=40 kg)

DRUG

Emtricitabine

emtricitabine (6 mg/kg QD, up to 200 mg QD capsule formulation or up to 240 mg QD using the oral solution) plus didanosine (240 mg/m2 up to 400 mg QD) plus efavirenz (up to 600 mg QD capsule formulation or up to 720 mg QD using the oral solution).

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2004-07-31
Completion
2004-07-31

Countries

  • Romania

Study Locations

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Entities

Drugs
Companies

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 NCT00642291 on ClinicalTrials.gov