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
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Abacavir sulfate (Drug); Lamivudine (Drug); Zidovudine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Glaxo Wellcome
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.
Clinical Details
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.
Study design: Treatment, Parallel Assignment, Safety Study
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.
Eligibility
Minimum age: 3 Months.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria
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.
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:
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.
Locations and Contacts
Univ Alabama - Birmingham / Dept of Pediatrics / UAB Station, Birmingham, Alabama 35294, United States
Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States
Children's Hosp Los Angeles, Los Angeles, California 90027, United States
Univ of South Florida All Children's Hosp, Saint Petersburg, Florida 33701, United States
Dr Patricia Emmanuel, Tampa, Florida 33606, United States
Arnold Palmer Hosp for Women and Children, Orlando, Florida 32806, United States
Children's Diagnostic Treatment Ctr, Fort Lauderdale, Florida 33301, United States
Pediatric Special Immunology Clinic / HRS / PBC PHU, Riviera Beach, Florida 33404, United States
Univ of Miami / Fox Cancer Research Ctr, Miami, Florida 33136, United States
Univ of Florida - Gainesville / Infectious Dis & Immun, Gainesville, Florida 326100296, 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
St Luke's - Roosevelt Hosp Ctr, New York, New York 10025, United States
PACT Program, Buffalo, New York 14222, 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
North Shore Univ Hosp / Pediatric Immunology, Great Neck, New York 11021, United States
Bronx Lebanon Hosp Ctr / Dept of Pediatrics, Bronx, New York 10457, United States
SUNY Health Sciences Ctr at Syracuse / Dept of Pediatrics, Syracuse, New York 13210, United States
SUNY Health Ctr at Stony Brook / Pediatric Infectious Dis, Stony Brook, New York 117948111, 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
Univ of Texas Health Sciences Ctr, San Antonio, Texas 78284, United States
Cook's Ft Worth Children Med Ctr / Pediatric Inf Dis, Fort Worth, Texas 76104, United States
Eastern VA Med Sch / Children's Hosp of the King's Daughters, Norfolk, Virginia 23507, United States
Additional Information
Last updated: June 23, 2005
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