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| Sponsored by: |
Gilead Sciences |
|---|---|
| Information provided by: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00642291 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Emtricitabine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects |
| Enrollment: | 16 |
| Study Start Date: | November 2002 |
| Study Completion Date: | July 2004 |
| Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Treatment naive pediatric patients (Group 1: ages 3 to 24 months)were to receive 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)
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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)
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2: Experimental
Treatment naive or experienced pediatric patients (Group 2: ages 7 to 12 years; Group 3: ages 13-17 years) received 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).
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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).
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Eligibility| Ages Eligible for Study: | 3 Months to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
OR
Exclusion Criteria:
Subjects with any of the following laboratory parameters at Screening:
Contacts and Locations
More Information
| Responsible Party: | Gilead Sciences ( Elsa Mondou, MD, Senior Director of Clinical Research ) |
| Study ID Numbers: | FTC-211 |
| Study First Received: | March 19, 2008 |
| Last Updated: | April 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00642291 History of Changes |
| Health Authority: | Romania: National Medicines Agency |
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Emtricitabine Pediatric HIV-1 Treatment of HIV-1 |
|
Efavirenz Sexually Transmitted Diseases, Viral Stavudine Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Virus Diseases Didanosine |
Anti-Retroviral Agents Emtricitabine Lopinavir HIV Infections Ritonavir Sexually Transmitted Diseases Retroviridae Infections |
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Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Virus Diseases Emtricitabine Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |