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

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002391
• Other study ID #: 238L
• Secondary ID: CNAA3006
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 1998
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 12 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Abacavir sulfate

• Lamivudine

• Zidovudine

Locations

Country	Name	City	State
United States	Univ Alabama - Birmingham / Dept of Pediatrics / UAB Station	Birmingham	Alabama
United States	Bronx Lebanon Hosp Ctr / Dept of Pediatrics	Bronx	New York
United States	PACT Program	Buffalo	New York
United States	Univ of North Carolina / Pediatric Infectious Diseases	Chapel Hill	North Carolina
United States	Med Univ of South Carolina	Charleston	South Carolina
United States	Mt Sinai Hosp Med Ctr / Dept of Pediatrics	Chicago	Illinois
United States	Children's Med Ctr of Dallas / ARMS Clinic	Dallas	Texas
United States	The Children's Med Ctr / Division of Infectious Dis	Dayton	Ohio
United States	Duke Univ Med Ctr / Pediatrics Dept / Infec Dis	Durham	North Carolina
United States	Children's Diagnostic Treatment Ctr	Fort Lauderdale	Florida
United States	Cook's Ft Worth Children Med Ctr / Pediatric Inf Dis	Fort Worth	Texas
United States	Univ of Florida - Gainesville / Infectious Dis & Immun	Gainesville	Florida
United States	North Shore Univ Hosp / Pediatric Immunology	Great Neck	New York
United States	Children's Hosp Los Angeles	Los Angeles	California
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	Univ of Miami / Fox Cancer Research Ctr	Miami	Florida
United States	Univ of Minnesota Med School	Minneapolis	Minnesota
United States	Schneider Children's Hosp	New Hyde Park	New York
United States	Tulane Univ Med School	New Orleans	Louisiana
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	UMDNJ / Division of Allergy Immunology & Infectious Diseases	Newark	New Jersey
United States	Eastern VA Med Sch / Children's Hosp of the King's Daughters	Norfolk	Virginia
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	Saint Petersburg	Florida
United States	Univ of Texas Health Sciences Ctr	San Antonio	Texas
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	Dr Patricia Emmanuel	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,