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
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.
2 other identifiers
interventional
N/A
1 country
30
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.
Trial Health
Trial Health Score
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30 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- 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:
- , 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.
You may not qualify if:
- 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.
- 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:
- Excluded:
- 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.
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (30)
Univ Alabama - Birmingham / Dept of Pediatrics / UAB Station
Birmingham, Alabama, 35294, United States
Children's Hosp Los Angeles
Los Angeles, California, 90027, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Children's Diagnostic Treatment Ctr
Fort Lauderdale, Florida, 33301, United States
Univ of Florida - Gainesville / Infectious Dis & Immun
Gainesville, Florida, 326100296, United States
Univ of Miami / Fox Cancer Research Ctr
Miami, Florida, 33136, United States
Arnold Palmer Hosp for Women and Children
Orlando, Florida, 32806, United States
Pediatric Special Immunology Clinic / HRS / PBC PHU
Riviera Beach, Florida, 33404, United States
Univ of South Florida All Children's Hosp
St. Petersburg, Florida, 33701, United States
Dr Patricia Emmanuel
Tampa, Florida, 33606, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608, United States
Tulane Univ Med School
New Orleans, Louisiana, 70112, United States
Univ of Minnesota Med School
Minneapolis, Minnesota, 55455, United States
UMDNJ / Division of Allergy Immunology & Infectious Diseases
Newark, New Jersey, 07103, United States
PACT Program
Buffalo, New York, 14222, United States
North Shore Univ Hosp / Pediatric Immunology
Great Neck, New York, 11021, United States
Schneider Children's Hosp
New Hyde Park, New York, 11040, United States
New York Hosp - Cornell / Program for Children with AIDS
New York, New York, 10021, United States
St Luke's - Roosevelt Hosp Ctr
New York, New York, 10025, United States
SUNY Health Ctr at Stony Brook / Pediatric Infectious Dis
Stony Brook, New York, 117948111, United States
SUNY Health Sciences Ctr at Syracuse / Dept of Pediatrics
Syracuse, New York, 13210, United States
Bronx Lebanon Hosp Ctr / Dept of Pediatrics
The Bronx, New York, 10457, United States
Univ of North Carolina / Pediatric Infectious Diseases
Chapel Hill, North Carolina, 27514, United States
Duke Univ Med Ctr / Pediatrics Dept / Infec Dis
Durham, North Carolina, 27710, United States
The Children's Med Ctr / Division of Infectious Dis
Dayton, Ohio, 454041815, United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312, United States
Children's Med Ctr of Dallas / ARMS Clinic
Dallas, Texas, 75235, United States
Cook's Ft Worth Children Med Ctr / Pediatric Inf Dis
Fort Worth, Texas, 76104, United States
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 78284, United States
Eastern VA Med Sch / Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1998-11