Back to resultsA Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zidovudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
Eligibility Criteria
Inclusion Criteria Patients must have: HIV infection. CD4 count >= 2000 cells/mm3 AND >= 30 percent of total lymphocytes. No signs or symptoms of HIV infection (other than lymphadenopathy, mild hepatomegaly, hypergammaglobulinemia, or splenomegaly, which is permitted). Consent of parent or guardian. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Serious acute infection requiring parenteral therapy at time of entry. One or more serious, proven bacterial infections including any of the following: septicemia; pneumonia; meningitis; bone or joint infection; or abscess of an internal organ or body cavity (excluding otitis media or superficial skin or mucosal abscesses) that are caused by Haemophilus, Streptococcus (including pneumococcus), or other pyogenic bacteria. Clinical neurologic/neuropsychologic deficits, or a head circumference less than the fifth percentile. Concurrent Medication: Excluded: Any agent with known antiretroviral activity. Acetaminophen, ibuprofen, or aspirin for more than 72 hours continuously. Prior Medication: Excluded: More than 7 weeks of prior antiretroviral or immunomodulator therapy post-natally. Recommended: PCP prophylaxis. Immunizations according to current recommendations.
Sites / Locations
- Univ of Alabama at Birmingham Schl of Med / Pediatrics
- Kaiser Permanente / UCLA Med Ctr
- UCLA Med Ctr / Pediatric
- Harbor - UCLA Med Ctr / UCLA School of Medicine
- San Francisco Gen Hosp
- UCSF / Moffitt Hosp - Pediatric
- Children's Hosp of Denver
- Univ of Connecticut / Farmington
- Yale Univ Med School
- Georgetown Univ Med Ctr
- Children's Hosp of Washington DC
- Howard Univ Hosp
- Univ of Miami (Pediatric)
- Cook County Hosp
- Univ of Illinois College of Medicine / Pediatrics
- Chicago Children's Memorial Hosp
- Univ of Chicago Children's Hosp
- Tulane Univ / Charity Hosp of New Orleans
- Univ of Maryland at Baltimore / Univ Med Ctr
- Children's Hosp of Boston
- Baystate Med Ctr of Springfield
- Univ of Massachusetts Med School
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
- Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
- Children's Hosp at Albany Med Ctr
- Lincoln Hosp Ctr
- Bronx Lebanon Hosp Ctr
- Albert Einstein College of Medicine
- King's County Hosp Ctr / Pediatrics
- Children's Hosp Pact Prog / Children's Hosp of Buffalo
- North Shore Univ Hosp
- Metropolitan Hosp Ctr
- Mount Sinai Med Ctr / Pediatrics
- Harlem Hosp Ctr
- Univ of Rochester Medical Center
- Westchester Hosp
- Duke Univ Med Ctr
- Columbus Children's Hosp
- Med Univ of South Carolina
- Saint Jude Children's Research Hosp of Memphis
- Children's Med Ctr of Dallas
- San Juan City Hosp
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000750
First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Glaxo Wellcome
1. Study Identification
Unique Protocol Identification Number
NCT00000750
Brief Title
A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection
Official Title
A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 1996 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Glaxo Wellcome
4. Oversight
5. Study Description
Brief Summary
Primary: To determine the efficacy of early treatment with zidovudine (AZT) in HIV-infected asymptomatic infants. To determine the safety and tolerance of AZT in this patient population.
Secondary: To compare the virologic and immunologic parameters between the treatment groups. To determine the efficacy of AZT as an early treatment to prevent development of CD4+ cell depletion in HIV-infected asymptomatic infants.
AZT is currently indicated for primary treatment in children with HIV-associated signs and symptoms and for those with significant immunodeficiency. This study will attempt to determine whether early treatment with AZT prevents the development of symptoms in HIV-infected infants who are asymptomatic.
Detailed Description
AZT is currently indicated for primary treatment in children with HIV-associated signs and symptoms and for those with significant immunodeficiency. This study will attempt to determine whether early treatment with AZT prevents the development of symptoms in HIV-infected infants who are asymptomatic.
Patients are randomized to receive oral AZT (at age-adjusted doses) or placebo. Patients are evaluated at weeks 2 and 4 and every 4 weeks thereafter; those who reach a study endpoint will have their treatment unblinded to allow the clinician to determine which treatment regimen the patient should then receive. Patients who meet the criteria for changes to open-label AZT will be given the appropriate age-adjusted dose without unblinding the original randomization assignment. Patients who complete or discontinue treatment are followed every 6 months for up to 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zidovudine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients must have:
HIV infection.
CD4 count >= 2000 cells/mm3 AND >= 30 percent of total lymphocytes.
No signs or symptoms of HIV infection (other than lymphadenopathy, mild hepatomegaly, hypergammaglobulinemia, or splenomegaly, which is permitted).
Consent of parent or guardian.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Serious acute infection requiring parenteral therapy at time of entry.
One or more serious, proven bacterial infections including any of the following:
septicemia; pneumonia; meningitis; bone or joint infection; or abscess of an internal organ or body cavity (excluding otitis media or superficial skin or mucosal abscesses) that are caused by Haemophilus, Streptococcus (including pneumococcus), or other pyogenic bacteria.
Clinical neurologic/neuropsychologic deficits, or a head circumference less than the fifth percentile.
Concurrent Medication:
Excluded:
Any agent with known antiretroviral activity.
Acetaminophen, ibuprofen, or aspirin for more than 72 hours continuously.
Prior Medication:
Excluded:
More than 7 weeks of prior antiretroviral or immunomodulator therapy post-natally.
Recommended:
PCP prophylaxis.
Immunizations according to current recommendations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E Connor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
G McSherry
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham Schl of Med / Pediatrics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Kaiser Permanente / UCLA Med Ctr
City
Downey
State/Province
California
ZIP/Postal Code
902422814
Country
United States
Facility Name
UCLA Med Ctr / Pediatric
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951752
Country
United States
Facility Name
Harbor - UCLA Med Ctr / UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
905022004
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
UCSF / Moffitt Hosp - Pediatric
City
San Francisco
State/Province
California
ZIP/Postal Code
941430105
Country
United States
Facility Name
Children's Hosp of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
802181088
Country
United States
Facility Name
Univ of Connecticut / Farmington
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Yale Univ Med School
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Children's Hosp of Washington DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200102916
Country
United States
Facility Name
Howard Univ Hosp
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Univ of Miami (Pediatric)
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Cook County Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Illinois College of Medicine / Pediatrics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago Children's Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606143394
Country
United States
Facility Name
Univ of Chicago Children's Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606371470
Country
United States
Facility Name
Tulane Univ / Charity Hosp of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Univ of Maryland at Baltimore / Univ Med Ctr
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Children's Hosp of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021155724
Country
United States
Facility Name
Baystate Med Ctr of Springfield
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Univ of Massachusetts Med School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
016550001
Country
United States
Facility Name
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032714
Country
United States
Facility Name
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071072198
Country
United States
Facility Name
Children's Hosp at Albany Med Ctr
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Lincoln Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
King's County Hosp Ctr / Pediatrics
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Children's Hosp Pact Prog / Children's Hosp of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
North Shore Univ Hosp
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Metropolitan Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mount Sinai Med Ctr / Pediatrics
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Westchester Hosp
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
277103499
Country
United States
Facility Name
Columbus Children's Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432052696
Country
United States
Facility Name
Med Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
294253312
Country
United States
Facility Name
Saint Jude Children's Research Hosp of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
381052794
Country
United States
Facility Name
Children's Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
San Juan City Hosp
City
San Juan
ZIP/Postal Code
009367344
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection
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