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:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/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 2017
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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) Other Names: Sustiva BMS-561525

Arms

Assigned Interventions

Experimental: 1

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)

Other Names:

Sustiva
BMS-561525

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

Locations

Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina, 1245
Local Institution
Buenos Aires, Argentina, 1425
Colombia
Local Institution
Cali, Colombia
Mexico
Local Institution
Df, Distrito Federal, Mexico, 06720
Local Institution
Guadalajara, Jalisco, Mexico, 44520
Local Institution
Guadalajara, Jalisco, Mexico, 44280
Local Institution
Morelia, Michioacan, Mexico, 58000
Local Institution
Monterrey, Nuevo Leon, Mexico, 64460
Local Institution
Colima, Mexico, 28019
Local Institution
Puebla, Mexico, 72000
Local Institution
San Luis Potosi, Mexico, 78240
Panama
Local Institution
Panama, Panama, 5-4087
South Africa
Local Institution
Bloemfontein, Free State, South Africa, 9301
Local Institution
Westdene, Gauteng, South Africa, 2092
Local Institution
Cape Town, Western Cape, South Africa, 7505
Thailand
Local Institution
Bangkok, Thailand, 10330
Local Institution
Bangkok, Thailand, 10700

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:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00364793 History of Changes
Other Study ID Numbers:	AI266-922
Study First Received:	August 15, 2006
Last Updated:	February 2, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

HIV, Pediatric

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Didanosine
Efavirenz

Emtricitabine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 09, 2012