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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002391

Run by

Glaxo Wellcome

Last updated by the study team

2005-06-24

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

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:
• 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.

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.
• 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:

Where it is running

• 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

Full record on ClinicalTrials.gov

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