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.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Glaxo Wellcome
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001066
First received: November 2, 1999
Last updated: March 1, 2011
Last verified: March 2011
  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 Intervention Phase
HIV Infections
Drug: Lamivudine
Drug: Zidovudine
Drug: Didanosine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 740
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
Detailed Description:

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 to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00001066

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00001066     History of Changes
Other Study ID Numbers: ACTG 300
Study First Received: November 2, 1999
Last Updated: March 1, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Didanosine
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Lamivudine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lamivudine
Zidovudine
Didanosine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Antimetabolites

ClinicalTrials.gov processed this record on September 18, 2014