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
NCT ID: NCT00002391
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PARALLEL
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abacavir sulfate
Lamivudine
Zidovudine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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:
* 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
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:
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.
* Investigational agents.
Concurrent Treatment:
Excluded:
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:
Excluded:
* 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.
Required:
\> 12 weeks prior antiretroviral therapy and unchanged therapy 12 weeks prior to screening.
3 Months
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Glaxo Wellcome
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Univ Alabama - Birmingham / Dept of Pediatrics / UAB Station
Birmingham, Alabama, United States
Children's Hosp Los Angeles
Los Angeles, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Children's Diagnostic Treatment Ctr
Fort Lauderdale, Florida, United States
Univ of Florida - Gainesville / Infectious Dis & Immun
Gainesville, Florida, United States
Univ of Miami / Fox Cancer Research Ctr
Miami, Florida, United States
Arnold Palmer Hosp for Women and Children
Orlando, Florida, United States
Pediatric Special Immunology Clinic / HRS / PBC PHU
Riviera Beach, Florida, United States
Univ of South Florida All Children's Hosp
St. Petersburg, Florida, United States
Dr Patricia Emmanuel
Tampa, Florida, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, United States
Tulane Univ Med School
New Orleans, Louisiana, United States
Univ of Minnesota Med School
Minneapolis, Minnesota, United States
UMDNJ / Division of Allergy Immunology & Infectious Diseases
Newark, New Jersey, United States
PACT Program
Buffalo, New York, United States
North Shore Univ Hosp / Pediatric Immunology
Great Neck, New York, United States
Schneider Children's Hosp
New Hyde Park, New York, United States
New York Hosp - Cornell / Program for Children with AIDS
New York, New York, United States
St Luke's - Roosevelt Hosp Ctr
New York, New York, United States
SUNY Health Ctr at Stony Brook / Pediatric Infectious Dis
Stony Brook, New York, United States
SUNY Health Sciences Ctr at Syracuse / Dept of Pediatrics
Syracuse, New York, United States
Bronx Lebanon Hosp Ctr / Dept of Pediatrics
The Bronx, New York, United States
Univ of North Carolina / Pediatric Infectious Diseases
Chapel Hill, North Carolina, United States
Duke Univ Med Ctr / Pediatrics Dept / Infec Dis
Durham, North Carolina, United States
The Children's Med Ctr / Division of Infectious Dis
Dayton, Ohio, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Children's Med Ctr of Dallas / ARMS Clinic
Dallas, Texas, United States
Cook's Ft Worth Children Med Ctr / Pediatric Inf Dis
Fort Worth, Texas, United States
Univ of Texas Health Sciences Ctr
San Antonio, Texas, United States
Eastern VA Med Sch / Children's Hosp of the King's Daughters
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CNAA3006
Identifier Type: -
Identifier Source: secondary_id
238L
Identifier Type: -
Identifier Source: org_study_id