- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000750
A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection
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.
Study Overview
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.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
San Juan, Puerto Rico, 009367344
- San Juan City Hosp
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Univ of Alabama at Birmingham Schl of Med / Pediatrics
-
-
California
-
Downey, California, United States, 902422814
- Kaiser Permanente / UCLA Med Ctr
-
Los Angeles, California, United States, 905022004
- Harbor - UCLA Med Ctr / UCLA School of Medicine
-
Los Angeles, California, United States, 900951752
- UCLA Med Ctr / Pediatric
-
San Francisco, California, United States, 94110
- San Francisco Gen Hosp
-
San Francisco, California, United States, 941430105
- UCSF / Moffitt Hosp - Pediatric
-
-
Colorado
-
Denver, Colorado, United States, 802181088
- Children's Hosp of Denver
-
-
Connecticut
-
Farmington, Connecticut, United States, 06032
- Univ of Connecticut / Farmington
-
New Haven, Connecticut, United States, 06504
- Yale Univ Med School
-
-
District of Columbia
-
Washington, District of Columbia, United States, 200102916
- Children's Hosp of Washington DC
-
Washington, District of Columbia, United States, 20007
- Georgetown Univ Med Ctr
-
Washington, District of Columbia, United States, 20060
- Howard Univ Hosp
-
-
Florida
-
Miami, Florida, United States, 33161
- Univ of Miami (Pediatric)
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Cook County Hosp
-
Chicago, Illinois, United States, 606143394
- Chicago Children's Memorial Hosp
-
Chicago, Illinois, United States, 606371470
- Univ of Chicago Children's Hosp
-
Chicago, Illinois, United States, 60612
- Univ of Illinois College of Medicine / Pediatrics
-
-
Louisiana
-
New Orleans, Louisiana, United States, 701122699
- Tulane Univ / Charity Hosp of New Orleans
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Univ of Maryland at Baltimore / Univ Med Ctr
-
-
Massachusetts
-
Boston, Massachusetts, United States, 021155724
- Children's Hosp of Boston
-
Springfield, Massachusetts, United States, 01199
- Baystate Med Ctr of Springfield
-
Worcester, Massachusetts, United States, 016550001
- Univ of Massachusetts Med School
-
-
New Jersey
-
Newark, New Jersey, United States, 071032714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
-
Newark, New Jersey, United States, 071072198
- Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
-
-
New York
-
Albany, New York, United States, 12208
- Children's Hosp at Albany Med Ctr
-
Bronx, New York, United States, 10461
- Albert Einstein College Of Medicine
-
Bronx, New York, United States, 10457
- Bronx Lebanon Hosp Ctr
-
Bronx, New York, United States, 10451
- Lincoln Hosp Ctr
-
Brooklyn, New York, United States, 11203
- King's County Hosp Ctr / Pediatrics
-
Buffalo, New York, United States, 14222
- Children's Hosp Pact Prog / Children's Hosp of Buffalo
-
Great Neck, New York, United States, 11021
- North Shore Univ Hosp
-
New York, New York, United States, 10029
- Metropolitan Hosp Ctr
-
New York, New York, United States, 10037
- Harlem Hosp Ctr
-
New York, New York, United States, 10029
- Mount Sinai Med Ctr / Pediatrics
-
Rochester, New York, United States, 14642
- Univ of Rochester Medical Center
-
Valhalla, New York, United States, 10595
- Westchester Hosp
-
-
North Carolina
-
Durham, North Carolina, United States, 277103499
- Duke Univ Med Ctr
-
-
Ohio
-
Columbus, Ohio, United States, 432052696
- Columbus Children's Hosp
-
-
South Carolina
-
Charleston, South Carolina, United States, 294253312
- Med Univ of South Carolina
-
-
Tennessee
-
Memphis, Tennessee, United States, 381052794
- Saint Jude Children's Research Hosp of Memphis
-
-
Texas
-
Dallas, Texas, United States, 75235
- Children's Med Ctr of Dallas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: G McSherry
Study record dates
Study Major Dates
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Zidovudine
Other Study ID Numbers
- ACTG 182
- 11157 (REGISTRY: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV Infections | HIV SeronegativityUnited States, Puerto Rico
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
Clinical Trials on Zidovudine
-
Glaxo WellcomeUnknownHIV InfectionsUnited States
-
Institut de Recherche pour le DeveloppementEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedHIV Infections | PregnancyThailand
-
Glaxo WellcomeCompleted
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
Glaxo WellcomeCompleted
-
Glaxo WellcomeCompletedHIV Infections | LipodystrophyUnited States
-
Universidad Peruana Cayetano HerediaMerck Sharp & Dohme LLCCompletedHTLV-I Infections | Tropical Spastic ParaparesisPeru
-
University of Colorado, DenverNational Institute of Allergy and Infectious Diseases (NIAID); University of...Completed
-
ViiV HealthcareCompleted
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV InfectionsUnited States, Puerto Rico