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Home > "A" Clinical Trials Conditions > A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination with Zidovudine in HIV-1 Infected Children

A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination with Zidovudine in HIV-1 Infected Children



A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination with Zidovudine in HIV-1 Infected Children

For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb,Glaxo Wellcome
Synopsis: To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1 infected children who received less than 56 days of prior antiretroviral therapy. To evaluate the safety and tolerance of 3TC/AZT in this patient population. To determine other measures of diseases in response to the study regimens. Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.
Details: Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile. Patients are randomized to receive oral 3TC/AZT, ddI/AZT, or ddI alone for at least 24 months. PER AMENDMENT 4/29/96: NOTE: Randomization to ZDV+ddI arm was terminated in Spring of 1996 based upon the results of ACTG 152. Patients on that arm will continue on blinded study drug and will be followed until the end of the study.
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 3 Months/15 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - IVIG. - Prophylaxis for opportunistic infection. - EPO. - G-CSF or GM-CSF. Patients must have: - Symptomatic HIV infection. - Less than 56 days of prior antiretroviral therapy. - Consent of parent or guardian. NOTE: - Co-enrollment on ACTG 219, ACTG 220, and certain ACTG opportunistic infection protocols is permitted. Prior Medication: Allowed: - Up to 56 days of prior antiretroviral therapy. - Prior immunomodulator therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Malignancy. - Hypersensitivity to a nucleoside analog. - Current grade 2 or higher amylase/lipase toxicity or grade 3 or 4 other toxicity. PER AMENDMENT 4/29/96: - Active opportunistic infection and/or serious bacterial infection at the time of entry. Concurrent Medication: Excluded: - Any other anti-HIV therapy. - Megestrol acetate ( Megace ). - Probenecid. - IV pentamidine. - Human growth hormone ( hGH ). - Systemic corticosteroids for more than 2 weeks. Prior Medication: Excluded: - Investigational drug therapy within 14 days prior to study entry.
Total Enrollment: 740

Location and Contact Information:

Overall Study Official:
McKinneyRE,  Study Chair, 

Arnold Palmer Hosp for Children & Women
Orlando,  Florida,  32806
United States
 

SUNY - Brooklyn
Brooklyn,  New York,  11203
United States
 

Rhode Island Hosp / Brown Univ
Providence,  Rhode Island,  02903
United States
 

Harlem Hosp Ctr
New York City,  New York,  10037
United States
 

Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore,  Maryland,  21201
United States
 

Case Western Reserve Univ - Pediatric
Cleveland,  Ohio,  44106
United States
 

Med Univ of South Carolina
Charleston,  South Carolina,  294253312
United States
 

Univ of Texas Health Science Ctr
San Antonio,  Texas,  78240
United States
 

Baystate Med Ctr of Springfield
Springfield,  Massachusetts,  01199
United States
 

Bellevue Hosp / New York Univ Med Ctr
New York City,  New York,  10016
United States
 

Children's Hosp at Albany Med Ctr
Albany,  New York,  12208
United States
 

Children's Med Ctr
Dayton,  Ohio,  454041518
United States
 

Univ of Florida
Gainesville,  Florida,  32610
United States
 

Texas Children's Hosp / Baylor Univ
Houston,  Texas,  77030
United States
 

Stanford Univ School of Medicine
Stanford,  California,  943054149
United States
 

Cincinnati Children's Hosp / Univ Hosp
Cincinnati,  Ohio,  452292899
United States
 

SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse,  New York,  13210
United States
 

All Children's Hosp
St. Petersburg,  Florida,  33701
United States
 

Saint Jude Children's Research Hosp of Memphis
Memphis,  Tennessee,  381052794
United States
 

Univ of California / Davis
Sacramento,  California,  958172208
United States
 

Children's Hosp of Washington DC
Washington D.C.,  District of Columbia,  200102916
United States
 

Univ of South Florida
Tampa,  Florida,  33606
United States
 

St Louis Children's Hosp
St. Louis,  Missouri,  63110
United States
 

Mayaguez Med Ctr
Mayaguez,  ,  00680
Puerto Rico
 

Howard Univ Hosp
Washington D.C.,  District of Columbia,  20060
United States
 

Cook - Fort Worth Children's Med Ctr
Ft. Worth,  Texas,  76104
United States
 

Children's Hosp of Michigan
Detroit,  Michigan,  48201
United States
 

Univ of Mississippi Med Ctr
Jackson,  Mississippi,  392165405
United States
 

Univ of Massachusetts Med School
Worcester,  Massachusetts,  016550001
United States
 

Univ of Illinois College of Medicine / Pediatrics
Chicago,  Illinois,  60612
United States
 

Yale Univ Med School
New Haven,  Connecticut,  06504
United States
 

Schneider Children's Hosp
New Hyde Park,  New York,  11040
United States
 

Saint Christopher's Hosp for Children
Philadelphia,  Pennsylvania,  191341095
United States
 

Children's Hosp of Boston
Boston,  Massachusetts,  021155724
United States
 

Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles,  California,  900276016
United States
 

Saint Joseph's Hosp
Tampa,  Florida,  33614
United States
 

Children's Hosp of Oakland
Oakland,  California,  946091809
United States
 

San Juan City Hosp
San Juan,  ,  009367344
Puerto Rico
 

Long Beach Memorial (Pediatric)
Long Beach,  California,  90801
United States
 

Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham,  North Carolina,  27710
United States
 

Boston City Hosp / Pediatrics
Boston,  Massachusetts,  02118
United States
 

Univ of South Carolina School of Med
Columbia,  South Carolina,  29203
United States
 

Mount Sinai Hosp Med Ctr
Chicago,  Illinois,  60608
United States
 

Mem Children's Hosp
Savannah,  Georgia,  31404
United States
 

Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark,  New Jersey,  07103
United States
 

Univ of Minnesota Med School
Minneapolis,  Minnesota,  55455
United States
 

Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan,  ,  009365067
Puerto Rico
 

Children's Diagnostic and Treatment Ctr of South Florida
Ft. Lauderdale,  Florida,  33301
United States
 

Beth Israel Med Ctr / Pediatrics
New York City,  New York,  10003
United States
 

Metropolitan Hosp Ctr
New York City,  New York,  10029
United States
 

Univ of Miami (Pediatric)
Miami,  Florida,  33161
United States
 

Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles,  California,  905022004
United States
 

North Shore Univ Hosp
Great Neck,  New York,  11021
United States
 

Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon,  ,  00956
Puerto Rico
 

Columbia Presbyterian Med Ctr
New York City,  New York,  10032
United States
 

Saint Luke's - Roosevelt Hosp Ctr
New York City,  New York,  10025
United States
 

UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla,  California,  920930672
United States
 

Children's Med Ctr of Dallas
Dallas,  Texas,  75235
United States
 

UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick,  New Jersey,  089030019
United States
 

HRS Palm Beach County Public Health Unit
West Palm Beach,  Florida,  33407
United States
 

Virginia Commonwealth Univ
Richmond,  Virginia,  232980413
United States
 

Tulane Univ / Charity Hosp of New Orleans
New Orleans,  Louisiana,  701122699
United States
 

Univ of Rochester Medical Center
Rochester,  New York,  14642
United States
 

UCLA Med Ctr / Pediatric
Los Angeles,  California,  900951752
United States
 

Westchester Hosp
Valhalla,  New York,  10595
United States
 

Johns Hopkins Hosp - Pediatric
Baltimore,  Maryland,  212874933
United States
 

Univ of Connecticut / Farmington
Farmington,  Connecticut,  06032
United States
 

Bronx Lebanon Hosp Ctr
Bronx,  New York,  10457
United States
 

UCSF / Moffitt Hosp - Pediatric
San Francisco,  California,  941430105
United States
 

Univ of Chicago Children's Hosp
Chicago,  Illinois,  606371470
United States
 

State Univ of New York at Stony Brook
Stony Brook,  New York,  117948111
United States
 

King's County Hosp Ctr / Pediatrics
Brooklyn,  New York,  11203
United States
 

Emory Univ Hosp / Pediatrics
Atlanta,  Georgia,  30306
United States
 

Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark,  New Jersey,  071032714
United States
 

Children's Hosp of Philadelphia
Philadelphia,  Pennsylvania,  191044318
United States
 

Children's Hosp of Denver
Denver,  Colorado,  802181088
United States
 

Hermann Hosp / Univ Texas Health Science Ctr
Houston,  Texas,  77030
United States
 

Children's Hosp of Buffalo
Buffalo,  New York,  14222
United States
 

Senetara Norfolk Gen Hosp
Norfolk,  Virginia,  23507
United States
 

Columbus Children's Hosp
Columbus,  Ohio,  432052696
United States
 

Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham,  Alabama,  35294
United States
 

Duke Univ Med Ctr
Durham,  North Carolina,  277103499
United States
 

Los Angeles County - USC Med Ctr
Los Angeles,  California,  90033
United States
 

Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark,  New Jersey,  071072198
United States
 

Cook County Hosp
Chicago,  Illinois,  60612
United States
 

Children's Hospital & Medical Center / Seattle ACTU
Seattle,  Washington,  981050371
United States
 

Arkansas Children's Hosp
Little Rock,  Arkansas,  72202
United States
 

Chicago Children's Memorial Hosp
Chicago,  Illinois,  606143394
United States
 

Med College of Georgia
Augusta,  Georgia,  30912
United States
 

Univ of Florida Health Science Ctr / Pediatrics
Jacksonville,  Florida,  32209
United States
 

Mount Sinai Med Ctr / Pediatrics
New York City,  New York,  10029
United States
 


Additional Information:
Study ID Numbers:
  ACTG 300; 
Study Start Date: 
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001066

Other Hiv Infections Studies:
1. A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons

2. A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of Accelerated Schedules

3. A Randomized Trial of the Efficacy and Safety of a Strategy of Starting with Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals with CD4+ Cell Counts Less than or Equal to 200/mm3

4. Dual Boosted- PI PK trial

5. A Study of Ritonavir (ABT-538) When Used with Nelfinavir in HIV-Infected Patients

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A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination with Zidovudine in HIV-1 Infected Children

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