A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection

NCT00000750 | Completed Phase 3

• 2 other identifiers: ACTG 18211157
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 42

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.

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine

Interventions

Zidovudine DRUG

Eligibility Criteria

• Age: 1 Day - 9 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Glaxo Wellcome: collaborator

Study Sites (42)

Univ of Alabama at Birmingham Schl of Med / Pediatrics

Birmingham, Alabama, 35294, United States

Location

Kaiser Permanente / UCLA Med Ctr

Downey, California, 902422814, United States

Location

UCLA Med Ctr / Pediatric

Los Angeles, California, 900951752, United States

Location

Harbor - UCLA Med Ctr / UCLA School of Medicine

Los Angeles, California, 905022004, United States

Location

San Francisco Gen Hosp

San Francisco, California, 94110, United States

Location

UCSF / Moffitt Hosp - Pediatric

San Francisco, California, 941430105, United States

Location

Children's Hosp of Denver

Denver, Colorado, 802181088, United States

Location

Univ of Connecticut / Farmington

Farmington, Connecticut, 06032, United States

Location

Yale Univ Med School

New Haven, Connecticut, 06504, United States

Location

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, 20007, United States

Location

Children's Hosp of Washington DC

Washington D.C., District of Columbia, 200102916, United States

Location

Howard Univ Hosp

Washington D.C., District of Columbia, 20060, United States

Location

Univ of Miami (Pediatric)

Miami, Florida, 33161, United States

Location

Cook County Hosp

Chicago, Illinois, 60612, United States

Location

Univ of Illinois College of Medicine / Pediatrics

Chicago, Illinois, 60612, United States

Location

Chicago Children's Memorial Hosp

Chicago, Illinois, 606143394, United States

Location

Univ of Chicago Children's Hosp

Chicago, Illinois, 606371470, United States

Location

Tulane Univ / Charity Hosp of New Orleans

New Orleans, Louisiana, 701122699, United States

Location

Univ of Maryland at Baltimore / Univ Med Ctr

Baltimore, Maryland, 21201, United States

Location

Children's Hosp of Boston

Boston, Massachusetts, 021155724, United States

Location

Baystate Med Ctr of Springfield

Springfield, Massachusetts, 01199, United States

Location

Univ of Massachusetts Med School

Worcester, Massachusetts, 016550001, United States

Location

Univ of Medicine & Dentistry of New Jersey / Univ Hosp

Newark, New Jersey, 071032714, United States

Location

Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl

Newark, New Jersey, 071072198, United States

Location

Children's Hosp at Albany Med Ctr

Albany, New York, 12208, United States

Location

King's County Hosp Ctr / Pediatrics

Brooklyn, New York, 11203, United States

Location

Children's Hosp Pact Prog / Children's Hosp of Buffalo

Buffalo, New York, 14222, United States

Location

North Shore Univ Hosp

Great Neck, New York, 11021, United States

Location

Metropolitan Hosp Ctr

New York, New York, 10029, United States

Location

Mount Sinai Med Ctr / Pediatrics

New York, New York, 10029, United States

Location

Harlem Hosp Ctr

New York, New York, 10037, United States

Location

Univ of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Lincoln Hosp Ctr

The Bronx, New York, 10451, United States

Location

Bronx Lebanon Hosp Ctr

The Bronx, New York, 10457, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Westchester Hosp

Valhalla, New York, 10595, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 277103499, United States

Location

Columbus Children's Hosp

Columbus, Ohio, 432052696, United States

Location

Med Univ of South Carolina

Charleston, South Carolina, 294253312, United States

Location

Saint Jude Children's Research Hosp of Memphis

Memphis, Tennessee, 381052794, United States

Location

Children's Med Ctr of Dallas

Dallas, Texas, 75235, United States

Location

San Juan City Hosp

San Juan, 009367344, Puerto Rico

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• E Connor

  STUDY CHAIR

• G McSherry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: September 1, 1996
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

US (41); PR (1)