Clinical Trial: A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination with Zidovudine in HIV-1 Infected Children

This study has been completed.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Bristol-Myers Squibb
Glaxo Wellcome
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study

Official Title: A Randomized Comparative Study of Combined Zidovudine-Lamivudine (3TC) vs. the Better of ddI Monotherapy vs. Zidovudine Plus ddl in Symptomatic HIV-1 Infected Children

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.

Eligibility

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:

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:

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.

Location Information


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

More Information

Click here for more information about Zidovudine

Click here for more information about Didanosine

Click here for more information about Lamivudine

Publications

[No authors listed] Combination therapies improve outlook for children with HIV disease. NIAID AIDS Agenda. 1997 Aug;:10. No abstract available.

McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173

James JS. Major pediatric study stopped early: combination treatment better. AIDS Treat News. 1997 Jul 4;(No 274):5-6. No abstract available.

Dankner WM, Lindsey JC, Levin MJ. Correlates of opportunistic infections in children infected with the human immunodeficiency virus managed before highly active antiretroviral therapy. Pediatr Infect Dis J. 2001 Jan;20(1):40-8.

Benjamin Jr DK, Miller WC, Benjamin DK, Ryder RW, Weber DJ, Walter E, McKinney RE. A comparison of height and weight velocity as a part of the composite endpoint in pediatric HIV. AIDS. 2003 Nov 7;17(16):2331-2336.

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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