The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used With and Without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002391
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
To compare the safety, tolerance, durability of the viral load response and the antiviral activity of the 1592U89/zidovudine(ZDV)/lamivudine (3TC) regimen vs. ZDV/3TC regimen. To determine the clinical efficacy of the two regimens as measured survival, disease progression, weight growth velocity, and neuropsychological or neurological changes. To assess the development of viral resistance and relative pharmacokinetics associated with each regimen.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Abacavir sulfate Drug: Lamivudine Drug: Zidovudine Phase 3

Detailed Description:
Patients are randomized to receive blinded treatment with ZDV/3TC alone or in combination with 1592U89, orally for 16 weeks. If after the 16-week period certain criteria are met, patients may have the option to switch to open-label treatment for the remainder of the study period.

Study Type : Interventional  (Clinical Trial)
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety and Efficacy of the Combination of 1592U89/Zidovudine (ZDV)/Lamivudine (3TC) Versus the Combination of Zidovudine (ZDV)/Lamivudine (3TC) in HIV-1 Therapy-Experienced Pediatric Patients.

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MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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Ages Eligible for Study:   3 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • Intravenous immunoglobulin G, erythropoietin, G-CSF and GM-CSF.
  • Opportunistic infection prophylaxis.

Patients must have:

  • HIV-1 infection documented by:

< 18 months of age:

  • one positive viral test culture and one other positive viral test (culture, PCR, p24 antigen, or Immune Complex Dissociation p24 antigen) on two different specimens.

>= 18 months of age:

  • two positive viral tests as stated above, one or both of which may be determined by a federally documented ELISA and confirmed by Western blot or Indirect Fluorescent Antibody test.
  • Any of the CDC Categories:
  • 1, 2, 3, and N, A, B, and C of the 1994 Revised Classification System for HIV Infection in Children Less than 13 Years of Age.
  • CD4+ count >= 15% within 14 days prior to study drug administration.
  • No active or ongoing AIDS-defining opportunistic infection that precludes absorption of study drug or observation of a study parameter.
  • Signed, informed consent from parent or legal guardian for patients under 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Serious bacterial infection that precludes absorption of study drug or observation of a study parameter.
  • Documented hypersensitivity to a nucleoside analog.
  • Co-enrollment in certain opportunistic infection protocols is not exclusionary if approval is obtained.
  • Malignancy.
  • Life-threatening infection or other chronic disease that may compromise patient safety.
  • Grade 3/4 clinical or laboratory toxicity or current grade 2 or higher pancreatic amylase or lipase toxicity as defined by the ACTG Toxicity Tables within 14 days prior to study entry.

Concurrent Medication:


  • Other anti-HIV therapy.
  • Probenecid.
  • Biologic response modifier (unless listed under included concurrent medication) and megestrol acetate.
  • Human growth hormone.
  • Immunomodulators and cytotoxic chemotherapeutic agents.
  • Systemic corticosteroids > 14 days without approval.
  • Investigational agents.

Concurrent Treatment:


Radiation therapy.

Patients with the following prior conditions are excluded:

  • History of clinically relevant pancreatitis or hepatitis within the past 6 months.
  • Participation in a vaccine trial.

Prior Medication:


  • Protease inhibitor therapy within 2 weeks prior to randomization.
  • Interleukins or interferons within 30 days prior to study drug administration.
  • Investigational drugs within 14 days prior to randomization.
  • HIV vaccine dose within past 30 days.


> 12 weeks prior antiretroviral therapy and unchanged therapy 12 weeks prior to screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002391

  Hide Study Locations
United States, Alabama
Univ Alabama - Birmingham / Dept of Pediatrics / UAB Station
Birmingham, Alabama, United States, 35294
United States, California
Children's Hosp Los Angeles
Los Angeles, California, United States, 90027
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
United States, Florida
Children's Diagnostic Treatment Ctr
Fort Lauderdale, Florida, United States, 33301
Univ of Florida - Gainesville / Infectious Dis & Immun
Gainesville, Florida, United States, 326100296
Univ of Miami / Fox Cancer Research Ctr
Miami, Florida, United States, 33136
Arnold Palmer Hosp for Women and Children
Orlando, Florida, United States, 32806
Pediatric Special Immunology Clinic / HRS / PBC PHU
Riviera Beach, Florida, United States, 33404
Univ of South Florida All Children's Hosp
Saint Petersburg, Florida, United States, 33701
Dr Patricia Emmanuel
Tampa, Florida, United States, 33606
United States, Illinois
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, United States, 60608
United States, Louisiana
Tulane Univ Med School
New Orleans, Louisiana, United States, 70112
United States, Minnesota
Univ of Minnesota Med School
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
UMDNJ / Division of Allergy Immunology & Infectious Diseases
Newark, New Jersey, United States, 07103
United States, New York
Bronx Lebanon Hosp Ctr / Dept of Pediatrics
Bronx, New York, United States, 10457
PACT Program
Buffalo, New York, United States, 14222
North Shore Univ Hosp / Pediatric Immunology
Great Neck, New York, United States, 11021
Schneider Children's Hosp
New Hyde Park, New York, United States, 11040
New York Hosp - Cornell / Program for Children with AIDS
New York, New York, United States, 10021
St Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10025
SUNY Health Ctr at Stony Brook / Pediatric Infectious Dis
Stony Brook, New York, United States, 117948111
SUNY Health Sciences Ctr at Syracuse / Dept of Pediatrics
Syracuse, New York, United States, 13210
United States, North Carolina
Univ of North Carolina / Pediatric Infectious Diseases
Chapel Hill, North Carolina, United States, 27514
Duke Univ Med Ctr / Pediatrics Dept / Infec Dis
Durham, North Carolina, United States, 27710
United States, Ohio
The Children's Med Ctr / Division of Infectious Dis
Dayton, Ohio, United States, 454041815
United States, South Carolina
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
United States, Texas
Children's Med Ctr of Dallas / ARMS Clinic
Dallas, Texas, United States, 75235
Cook's Ft Worth Children Med Ctr / Pediatric Inf Dis
Fort Worth, Texas, United States, 76104
Univ of Texas Health Sciences Ctr
San Antonio, Texas, United States, 78284
United States, Virginia
Eastern VA Med Sch / Children's Hosp of the King's Daughters
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Glaxo Wellcome Identifier: NCT00002391     History of Changes
Other Study ID Numbers: 238L
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 1998

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Child Development

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents