Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00016718

Purpose

Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study is to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who have taken few or no anti-HIV drugs.

Condition	Intervention	Phase
HIV Infections	Drug: Didanosine Drug: Efavirenz Drug: Emtricitabine	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study to Evaluate the Safety, Tolerance, Antiviral Activity, and Pharmacokinetics of Emtricitabine in Combination With Efavirenz and Didanosine in a Once-Daily Regimen in HIV Infected, Antiretroviral Therapy Naive or Very Limited Antiretroviral Exposed Pediatric Subjects

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Didanosine Efavirenz

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Development of Grade 3 or 4 adverse events attributed to the study treatment [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Suppression of HIV viral load to less than 400 copies/ml and 50 copies/ml at Week 16 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Time to virologic failure at or after Week 16 [ Time Frame: Throughout study after Week 16 ] [ Designated as safety issue: No ]

Enrollment:	53
Study Start Date:	June 2005
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental All patients will receive ddI, EFV, and FTC together once daily. Study visits will occur at study entry, Weeks 2 and 4, and every 4 weeks thereafter.	Drug: Didanosine Antiretroviral Drug: Efavirenz Antiretroviral Drug: Emtricitabine Antiretroviral

Detailed Description:

Anti-HIV treatment options are limited for pediatric patients because combination therapies recommended for adults may not be appropriate for children or adolescents. Few PIs are available in formulations appropriate for pediatric patients, and complex dosing schedules and food requirements may be detrimental to treatment adherence. A once-daily regimen of the NRTIs ddI and FTC and the nonnucleoside reverse transcriptase inhibitor (NNRTI) EFV has been shown safe and well tolerated in adults. This study will evaluate the long-term safety and efficacy of a ddI, FTC, and EFV regimen in pediatric patients.

Patients will be followed for a maximum of 192 weeks; all patients will receive ddI, EFV, and FTC together once daily. Study visits will occur at study entry, Weeks 2 and 4, and every 4 weeks thereafter. Blood collection, medical history assessment, and a physical exam will occur at all visits; urine collection will occur at selected visits. Intensive pharmacokinetic (PK) studies will be done at Weeks 2 and 12 to determine if dose adjustments are required for any of the drugs. If virologic failure is determined, PK studies will be repeated 4 weeks after adjustments in therapy. Parents or guardians will be asked to complete treatment adherence questionnaires at some visits. Some patients may also be asked to participate in an additional PK study after Week 16 or week 96.

Eligibility

Ages Eligible for Study:	90 Days to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV infected
Antiretroviral naive OR have received no more than 56 days of drugs to prevent mother-to-child transmission of HIV OR have received less than 7 total days of antiretroviral therapy
Viral load of 5,000 copies/ml or more
Parent or guardian willing to provide informed consent, if applicable
Willing to use acceptable forms of contraception

Exclusion Criteria:

Allergic to study medications or their formulations
Kidney disease
Positive for hepatitis B or C
AIDS-related or other infection requiring treatment at study entry
Taking drugs to treat tuberculosis
Taking anti-HIV drugs other than those included in this study
Taking any investigational drugs
Anti-cancer drugs within 1 year of study screening
Serious medical event within 21 days of study screening
Active or history of pancreatitis
Require certain medications. Patients requiring short courses of steroids (less than 14 days) for asthma are not excluded.
Active or history of significant peripheral neuropathy
Difficulty with food or severe chronic diarrhea within 30 days before study entry
Unable to eat at least 1 meal per day (or to feed at least 3 times per day, for infants) because of chronic nausea, vomiting, swallowing problems, or stomach upset
Unable to swallow oral medications
Pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016718

Show 32 Study Locations

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Study Chair:	Ross E. McKinney, Jr., MD	Duke University
Study Chair:	Mobeen H. Rathore, MD	Pediatric Infectious Diseases/Immunology, University of Florida Health Science Center

More Information

Additional Information:

Click here for more information about didanosine This link exits the ClinicalTrials.gov site

Click here for more information about efavirenz This link exits the ClinicalTrials.gov site

Click here for more information about emtricitabine This link exits the ClinicalTrials.gov site

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

Publications:

McKinney RE Jr, Cunningham CK. Newer treatments for HIV in children. Curr Opin Pediatr. 2004 Feb;16(1):76-9. Review.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	ACTG P1021, PACTG P1021, IMPAACT P1021, 10038
Study First Received:	May 31, 2001
Last Updated:	October 8, 2009
ClinicalTrials.gov Identifier:	NCT00016718 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Didanosine
Drug Therapy, Combination
Drug Administration Schedule
Reverse Transcriptase Inhibitors
Anti-HIV Agents

Pharmacokinetics
Deoxycytidine
Efavirenz
Treatment Naive

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 November 22, 2009