To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1 infected children who received less than 56 days of prior antiretroviral therapy. To evaluate the safety and tolerance of 3TC/AZT in this patient population. To determine other measures of diseases in response to the study regimens. Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Lamivudine  Drug: Zidovudine  Drug: Didanosine	Phase II

Further Study Details: 

Expected Total Enrollment:  740

Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.

Patients are randomized to receive oral 3TC/AZT, ddI/AZT, or ddI alone for at least 24 months. PER AMENDMENT 4/29/96: NOTE: Randomization to ZDV+ddI arm was terminated in Spring of 1996 based upon the results of ACTG 152. Patients on that arm will continue on blinded study drug and will be followed until the end of the study.

Ages Eligible for Study:  3 Months   -   15 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

• IVIG.
• Prophylaxis for opportunistic infection.
• EPO.
• G-CSF or GM-CSF.

Patients must have:

• Symptomatic HIV infection.
• Less than 56 days of prior antiretroviral therapy.
• Consent of parent or guardian.

NOTE:

• Co-enrollment on ACTG 219, ACTG 220, and certain ACTG opportunistic infection protocols is permitted.

Prior Medication: Allowed:

• Up to 56 days of prior antiretroviral therapy.
• Prior immunomodulator therapy.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded:

• Malignancy.
• Hypersensitivity to a nucleoside analog.
• Current grade 2 or higher amylase/lipase toxicity or grade 3 or 4 other toxicity.

PER AMENDMENT 4/29/96:

• Active opportunistic infection and/or serious bacterial infection at the time of entry.

Concurrent Medication: Excluded:

• Any other anti-HIV therapy.
• Megestrol acetate ( Megace ).
• Probenecid.
• IV pentamidine.
• Human growth hormone ( hGH ).
• Systemic corticosteroids for more than 2 weeks.

Prior Medication: Excluded:

• Investigational drug therapy within 14 days prior to study entry.

Alabama
      Univ of Alabama at Birmingham Schl of Med / Pediatrics, Birmingham,  Alabama,  35294,  United States
Arkansas
      Arkansas Children's Hosp, Little Rock,  Arkansas,  72202,  United States
California
      UCSF / Moffitt Hosp - Pediatric, San Francisco,  California,  941430105,  United States
      UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla,  California,  920930672,  United States
      Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles,  California,  905022004,  United States
      Children's Hosp of Oakland, Oakland,  California,  946091809,  United States
      UCLA Med Ctr / Pediatric, Los Angeles,  California,  900951752,  United States
      Children's Hosp of Los Angeles/UCLA Med Ctr, Los Angeles,  California,  900276016,  United States
      Long Beach Memorial (Pediatric), Long Beach,  California,  90801,  United States
      Los Angeles County - USC Med Ctr, Los Angeles,  California,  90033,  United States
      Univ of California / Davis, Sacramento,  California,  958172208,  United States
      Stanford Univ School of Medicine, Stanford,  California,  943054149,  United States
Colorado
      Children's Hosp of Denver, Denver,  Colorado,  802181088,  United States
Connecticut
      Yale Univ Med School, New Haven,  Connecticut,  06504,  United States
      Univ of Connecticut / Farmington, Farmington,  Connecticut,  06032,  United States
District of Columbia
      Howard Univ Hosp, Washington,  District of Columbia,  20060,  United States
      Children's Hosp of Washington DC, Washington,  District of Columbia,  200102916,  United States
Florida
      Univ of Miami (Pediatric), Miami,  Florida,  33161,  United States
      Univ of Florida Health Science Ctr / Pediatrics, Jacksonville,  Florida,  32209,  United States
      All Children's Hosp, St. Petersburg,  Florida,  33701,  United States
      Children's Diagnostic and Treatment Ctr of South Florida, Fort Lauderdale,  Florida,  33301,  United States
      Univ of Florida, Gainesville,  Florida,  32610,  United States
      Univ of South Florida, Tampa,  Florida,  33606,  United States
      Arnold Palmer Hosp for Children & Women, Orlando,  Florida,  32806,  United States
      HRS Palm Beach County Public Health Unit, West Palm Beach,  Florida,  33407,  United States
      Saint Joseph's Hosp, Tampa,  Florida,  33614,  United States
Georgia
      Emory Univ Hosp / Pediatrics, Atlanta,  Georgia,  30306,  United States
      Mem Children's Hosp, Savannah,  Georgia,  31404,  United States
      Med College of Georgia, Augusta,  Georgia,  30912,  United States
Illinois
      Chicago Children's Memorial Hosp, Chicago,  Illinois,  606143394,  United States
      Cook County Hosp, Chicago,  Illinois,  60612,  United States
      Univ of Illinois College of Medicine / Pediatrics, Chicago,  Illinois,  60612,  United States
      Univ of Chicago Children's Hosp, Chicago,  Illinois,  606371470,  United States
      Mount Sinai Hosp Med Ctr, Chicago,  Illinois,  60608,  United States
Louisiana
      Tulane Univ / Charity Hosp of New Orleans, New Orleans,  Louisiana,  701122699,  United States
Maryland
      Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore,  Maryland,  21201,  United States
      Johns Hopkins Hosp - Pediatric, Baltimore,  Maryland,  212874933,  United States
Massachusetts
      Children's Hosp of Boston, Boston,  Massachusetts,  021155724,  United States
      Boston City Hosp / Pediatrics, Boston,  Massachusetts,  02118,  United States
      Baystate Med Ctr of Springfield, Springfield,  Massachusetts,  01199,  United States
      Univ of Massachusetts Med School, Worcester,  Massachusetts,  016550001,  United States
Michigan
      Children's Hosp of Michigan, Detroit,  Michigan,  48201,  United States
Minnesota
      Univ of Minnesota Med School, Minneapolis,  Minnesota,  55455,  United States
Mississippi
      Univ of Mississippi Med Ctr, Jackson,  Mississippi,  392165405,  United States
Missouri
      St Louis Children's Hosp, St. Louis,  Missouri,  63110,  United States
New Jersey
      Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark,  New Jersey,  071032714,  United States
      UMDNJ - Robert Wood Johnson Med School / Pediatrics, New Brunswick,  New Jersey,  089030019,  United States
      Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl, Newark,  New Jersey,  071072198,  United States
      Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl, Newark,  New Jersey,  07103,  United States
New York
      King's County Hosp Ctr / Pediatrics, Brooklyn,  New York,  11203,  United States
      Harlem Hosp Ctr, New York,  New York,  10037,  United States
      SUNY - Brooklyn, Brooklyn,  New York,  11203,  United States
      North Shore Univ Hosp, Great Neck,  New York,  11021,  United States
      Westchester Hosp, Valhalla,  New York,  10595,  United States
      Schneider Children's Hosp, New Hyde Park,  New York,  11040,  United States
      Univ of Rochester Medical Center, Rochester,  New York,  14642,  United States
      Bellevue Hosp / New York Univ Med Ctr, New York,  New York,  10016,  United States
      Columbia Presbyterian Med Ctr, New York,  New York,  10032,  United States
      Mount Sinai Med Ctr / Pediatrics, New York,  New York,  10029,  United States
      Metropolitan Hosp Ctr, New York,  New York,  10029,  United States
      Children's Hosp at Albany Med Ctr, Albany,  New York,  12208,  United States
      SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse,  New York,  13210,  United States
      Bronx Lebanon Hosp Ctr, Bronx,  New York,  10457,  United States
      State Univ of New York at Stony Brook, Stony Brook,  New York,  117948111,  United States
      Beth Israel Med Ctr / Pediatrics, New York,  New York,  10003,  United States
      Children's Hosp of Buffalo, Buffalo,  New York,  14222,  United States
      Saint Luke's - Roosevelt Hosp Ctr, New York,  New York,  10025,  United States
North Carolina
      Duke Univ Med Ctr, Durham,  North Carolina,  277103499,  United States
      Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr, Durham,  North Carolina,  27710,  United States
Ohio
      Case Western Reserve Univ - Pediatric, Cleveland,  Ohio,  44106,  United States
      Cincinnati Children's Hosp / Univ Hosp, Cincinnati,  Ohio,  452292899,  United States
      Columbus Children's Hosp, Columbus,  Ohio,  432052696,  United States
      Children's Med Ctr, Dayton,  Ohio,  454041518,  United States
Pennsylvania
      Children's Hosp of Philadelphia, Philadelphia,  Pennsylvania,  191044318,  United States
      Saint Christopher's Hosp for Children, Philadelphia,  Pennsylvania,  191341095,  United States
Rhode Island
      Rhode Island Hosp / Brown Univ, Providence,  Rhode Island,  02903,  United States
South Carolina
      Med Univ of South Carolina, Charleston,  South Carolina,  294253312,  United States
      Univ of South Carolina School of Med, Columbia,  South Carolina,  29203,  United States
Tennessee
      Saint Jude Children's Research Hosp of Memphis, Memphis,  Tennessee,  381052794,  United States
Texas
      Children's Med Ctr of Dallas, Dallas,  Texas,  75235,  United States
      Hermann Hosp / Univ Texas Health Science Ctr, Houston,  Texas,  77030,  United States
      Texas Children's Hosp / Baylor Univ, Houston,  Texas,  77030,  United States
      Cook - Fort Worth Children's Med Ctr, Fort Worth,  Texas,  76104,  United States
      Univ of Texas Health Science Ctr, San Antonio,  Texas,  78240,  United States
Virginia
      Senetara Norfolk Gen Hosp, Norfolk,  Virginia,  23507,  United States
      Virginia Commonwealth Univ, Richmond,  Virginia,  232980413,  United States
Washington
      Children's Hospital & Medical Center / Seattle ACTU, Seattle,  Washington,  981050371,  United States
Puerto Rico
      San Juan City Hosp, San Juan,  009367344,  Puerto Rico
      Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan,  009365067,  Puerto Rico
      Ramon Ruiz Arnau Univ Hosp / Pediatrics, Bayamon,  00956,  Puerto Rico
      Mayaguez Med Ctr, Mayaguez,  00680,  Puerto Rico

Study chairs or principal investigators

McKinney RE,  Study Chair
Johnson GM,  Study Chair

Study ID Numbers:  ACTG 300
Record last reviewed:  November 1998
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00001066
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08