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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00016718
First received: May 31, 2001
Last updated: May 3, 2013
Last verified: May 2013

May 31, 2001
May 3, 2013
August 2001
January 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Development of Grade 3 or 4 adverse events attributed to the study treatment
  • suppression of HIV viral load to less than 400 copies/ml and 50 copies/ml at Week 16
  • time to virologic failure at or after Week 16
Complete list of historical versions of study NCT00016718 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs
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

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Didanosine
    Antiretroviral
  • Drug: Efavirenz
    Antiretroviral
  • Drug: Emtricitabine
    Antiretroviral
Experimental: 1
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.
Interventions:
  • Drug: Didanosine
  • Drug: Efavirenz
  • Drug: Emtricitabine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
90 Days to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00016718
P1021, 10038, ACTG P1021, PACTG P1021, IMPAACT P1021
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
National Institute of Allergy and Infectious Diseases (NIAID)
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP