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
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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: 43
Study Start Date: August 2001
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States
UCSF Pediatric AIDS CRS
San Francisco, California, United States, 941430105
United States, Colorado
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States, 802181088
United States, District of Columbia
Howard Univ. Washington DC NICHD CRS
Washington, District of Columbia, United States, 20060
United States, Florida
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States, 33161
United States, Illinois
Rush Univ. Cook County Hosp. Chicago NICHD CRS
Chicago, Illinois, United States
Chicago Children's CRS
Chicago, Illinois, United States, 606143394
United States, Massachusetts
Children's Hosp. of Boston NICHD CRS
Boston, Massachusetts, United States, 021155724
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States, 016550001
United States, New York
Nyu Ny Nichd Crs
New York, New York, United States, 10016
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States, 13210
United States, North Carolina
DUMC Ped. CRS
Durham, North Carolina, United States, 277103499
United States, Tennessee
St. Jude/UTHSC CRS
Memphis, Tennessee, United States, 381052794
United States, Texas
Texas Children's Hosp. CRS
Houston, Texas, United States, 77030
Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 009367344
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico, 009365067
Sponsors and Collaborators
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:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00016718     History of Changes
Other Study ID Numbers: P1021, 10038, ACTG P1021, PACTG P1021, IMPAACT P1021
Study First Received: May 31, 2001
Last Updated: May 3, 2013
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Anti-HIV Agents
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Didanosine
Efavirenz
Emtricitabine
Reverse Transcriptase Inhibitors
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014