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	Treatment or Intervention	Phase
HIV Infections	Drug: Didanosine  Drug: Efavirenz  Drug: Emtricitabine	Phase I Phase II

Further Study Details: 

Primary Outcomes: 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
Expected Total Enrollment:  53

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.

Ages Eligible for Study:  90 Days   -   21 Years,  Genders Eligible for Study:  Both

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

Alabama
      Univ of Alabama at Birmingham - Pediatric, Birmingham,  Alabama,  35233,  United States; Recruiting
California
      UCSF / Moffitt Hosp - Pediatric, San Francisco,  California,  941430105,  United States; Recruiting
      Los Angeles County - USC Med Ctr, Los Angeles,  California,  90033,  United States; No longer recruiting
Colorado
      Children's Hosp of Denver, Denver,  Colorado,  802181088,  United States; Recruiting
Connecticut
      Connecticut Childrens Med Ctr (Pediatric), Farmington,  Connecticut,  06030-3805,  United States; Recruiting
District of Columbia
      Howard Univ Hosp, Washington,  District of Columbia,  20060,  United States; Recruiting
Florida
      Univ of Miami (Pediatric), Miami,  Florida,  33161,  United States; Recruiting
      Univ of Florida Health Science Ctr / Pediatrics, Jacksonville,  Florida,  32209,  United States; Recruiting
Illinois
      Chicago Children's Memorial Hosp, Chicago,  Illinois,  606143394,  United States; Recruiting
      Univ of Chicago Children's Hosp, Chicago,  Illinois,  60637,  United States; Recruiting
Louisiana
      Tulane Univ, Charity Hosp of New Orleans, New Orleans,  Louisiana,  70112,  United States; Recruiting
Massachusetts
      Children's Hosp of Boston, Boston,  Massachusetts,  021155724,  United States; Recruiting
      Univ of Massachusetts Med School, Worcester,  Massachusetts,  016550001,  United States; Recruiting
Mississippi
      Univ of Mississippi Med Ctr, Jackson,  Mississippi,  39213,  United States; No longer recruiting
Missouri
      St. Louis Children's Hosp, St. Louis,  Missouri,  63108,  United States; No longer recruiting
New York
      NYU/Bellevue Hosp, New York,  New York,  10016,  United States; Recruiting
      Columbia Presbyterian Med Ctr, New York,  New York,  10032,  United States; No longer recruiting
      Metropolitan Hosp Ctr, New York,  New York,  10029,  United States; No longer recruiting
      SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse,  New York,  13210,  United States; Recruiting
      State Univ of New York at Stony Brook, Stony Brook,  New York,  117948111,  United States; Recruiting
North Carolina
      Duke Univ Med Ctr, Durham,  North Carolina,  277103499,  United States; Recruiting
South Carolina
      Med Univ of South Carolina, Charleston,  South Carolina,  294253312,  United States; No longer recruiting
Tennessee
      Saint Jude Children's Research Hosp of Memphis, Memphis,  Tennessee,  381052794,  United States; Recruiting
Texas
      Texas Children's Hosp / Baylor Univ, Houston,  Texas,  77030,  United States; Recruiting
Puerto Rico
      San Juan City Hosp, San Juan,  009367344,  Puerto Rico; Recruiting
      Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan,  009365067,  Puerto Rico; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  ACTG P1021; PACTG P1021
Record last reviewed:  March 2005
Last Updated:  April 4, 2005
Record first received:  May 31, 2001
ClinicalTrials.gov Identifier:  NCT00016718
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08