Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00364793

Purpose

The primary purpose of this study is to find the dose of Efavirenz for young children. The safety and how the medication is tolerated will also be studied.

Condition	Intervention	Phase
HIV Infections	Drug: Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	An Open-label Study of Liquid and Sprinkled Formulations of Efavirenz Administered in Combination With Didanosine and Emtricitabine in HIV-infected Infants and Children 3 Months to 6 Years of Age.

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Didanosine Efavirenz

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Pharmacokinetics of EFV derived from plasma concentrations versus time. [ Time Frame: Week 24 and 48 analysis of PK assessments (Weeks 2, 10 and potentially one other time) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy as measured by the proportion of subjects with plasma HIV RNA levels <400 copies/mL and <50 copies/mL [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
Safety as measured by the frequency and severity of [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: Yes ]
adverse events [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: Yes ]
treatment-related adverse events [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: Yes ]
serious adverse events [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: Yes ]
discontinuation from study due to adverse events [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: Yes ]
laboratory abnormalities [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	32
Study Start Date:	February 2007
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC) Oral Solution, Capsules or Tablets, Oral, once daily Efavirenz (EFV) per weight-based dosing nomogram (max 720 mg) Didanosine (ddI) 240 mg/m2 (max 400 mg) Emtricitabine (FTC) 6 mg/kg (max 200 mg) Where EFV oral solution is commercially available: 48 weeks or until 3rd birthday (whichever is longer); Where EFV oral solution NOT commercially available: until 7th birthday or until able to swallow EFV capsules (whichever occurs first)

Arms

Assigned Interventions

1: Experimental

Drug: Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)

Oral Solution, Capsules or Tablets, Oral, once daily

Efavirenz (EFV) per weight-based dosing nomogram (max 720 mg)

Didanosine (ddI) 240 mg/m2 (max 400 mg)

Emtricitabine (FTC) 6 mg/kg (max 200 mg)

Where EFV oral solution is commercially available: 48 weeks or until 3rd birthday (whichever is longer);

Where EFV oral solution NOT commercially available: until 7th birthday or until able to swallow EFV capsules (whichever occurs first)

Eligibility

Ages Eligible for Study:	3 Months to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV-1 infected; >=3 months of age to <=6 years of age (at time of treatment); screening plasma viral load >=1000 copies/mL

Exclusion Criteria:

Genotypic or phenotypic resistance to EFV, ddl, or FTC/3TC at screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364793

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

Argentina
Local Institution	Recruiting
Buenos Aires, Argentina, 1425
Contact: Site 018
Argentina, Buenos Aires
Local Institution	Recruiting
Capital Federal, Buenos Aires, Argentina, 1245
Contact: Site 020
Mexico
Local Institution	Recruiting
Colima, Mexico, 28019
Contact: Site 004
Local Institution	Recruiting
Puebla, Mexico, 72000
Contact: Site 008
Local Institution	Completed
San Luis Potosi, Mexico, 78240
Local Institution	Recruiting
Veracruz, Mexico, 91900
Contact: Site 017
Mexico, Distrito Federal
Local Institution	Recruiting
Df, Distrito Federal, Mexico, 06720
Contact: Site 005
Local Institution	Recruiting
Df, Distrito Federal, Mexico, 04530
Contact: Site 009
Mexico, Jalisco
Local Institution	Recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Site 002
Local Institution	Recruiting
Guadalajara, Jalisco, Mexico, 44520
Contact: Site 006
Mexico, Michioacan
Local Institution	Recruiting
Morelia, Michioacan, Mexico, 58000
Contact: Site 001
Mexico, Nuevo Leon
Local Institution	Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: Site 003
Panama
Local Institution	Recruiting
Panama, Panama, 5-4087
Contact: Site 019
South Africa, Gauteng
Local Institution	Not yet recruiting
Johannesburg, Gauteng, South Africa, 2092
Contact: Site 021
South Africa, Western Cape
Local Institution	Not yet recruiting
Cape Town, Western Cape, South Africa, 7505
Contact: Site 022

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	AI266-922
Study First Received:	August 15, 2006
Last Updated:	February 3, 2010
ClinicalTrials.gov Identifier:	NCT00364793 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

HIV, Pediatric

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Emtricitabine
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Efavirenz

RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Didanosine
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on February 08, 2010