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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.


Phase 3
3 Months
12 Years
Not Enrolling
Both
HIV Infections

Thank you

Trial Information

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.


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

238L

NCT ID:

NCT00002391

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • HIV-1
  • Drug Therapy, Combination
  • Zidovudine
  • Lamivudine
  • Reverse Transcriptase Inhibitors
  • Anti-HIV Agents
  • Viral Load
  • Child Development
  • abacavir
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

Los Angeles County - USC Med CtrLos Angeles, California  90033
Med Univ of South CarolinaCharleston, South Carolina  294253312
Univ of Texas Health Sciences CtrSan Antonio, Texas  782847838
Tulane Univ Med SchoolNew Orleans, Louisiana  70112
Univ Alabama - Birmingham / Dept of Pediatrics / UAB StationBirmingham, Alabama  35294
Children's Hosp Los AngelesLos Angeles, California  90027
Children's Diagnostic Treatment CtrFort Lauderdale, Florida  33301
Univ of Florida - Gainesville / Infectious Dis & ImmunGainesville, Florida  326100296
Univ of Miami / Fox Cancer Research CtrMiami, Florida  33136
Arnold Palmer Hosp for Women and ChildrenOrlando, Florida  32806
Pediatric Special Immunology Clinic / HRS / PBC PHURiviera Beach, Florida  33404
Univ of South Florida All Children's HospSaint Petersburg, Florida  33701
Dr Patricia EmmanuelTampa, Florida  33606
Mt Sinai Hosp Med Ctr / Dept of PediatricsChicago, Illinois  60608
Univ of Minnesota Med SchoolMinneapolis, Minnesota  55455
UMDNJ / Division of Allergy Immunology & Infectious DiseasesNewark, New Jersey  07103
Bronx Lebanon Hosp Ctr / Dept of PediatricsBronx, New York  10457
PACT ProgramBuffalo, New York  14222
North Shore Univ Hosp / Pediatric ImmunologyGreat Neck, New York  11021
Schneider Children's HospNew Hyde Park, New York  11040
New York Hosp - Cornell / Program for Children with AIDSNew York, New York  10021
St Luke's - Roosevelt Hosp CtrNew York, New York  10025
SUNY Health Ctr at Stony Brook / Pediatric Infectious DisStony Brook, New York  117948111
SUNY Health Sciences Ctr at Syracuse / Dept of PediatricsSyracuse, New York  13210
Univ of North Carolina / Pediatric Infectious DiseasesChapel Hill, North Carolina  27514
Duke Univ Med Ctr / Pediatrics Dept / Infec DisDurham, North Carolina  27710
The Children's Med Ctr / Division of Infectious DisDayton, Ohio  454041815
Children's Med Ctr of Dallas / ARMS ClinicDallas, Texas  75235
Cook's Ft Worth Children Med Ctr / Pediatric Inf DisFort Worth, Texas  76104
Eastern VA Med Sch / Children's Hosp of the King's DaughtersNorfolk, Virginia  23507