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

This study has been completed.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Glaxo Wellcome
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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.

Condition Treatment or Intervention Phase
HIV Infections
 Drug: Zidovudine
Phase III

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Pharmacokinetics Study

Further Study Details: 

Expected Total Enrollment:  400

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.

Eligibility

Ages Eligible for Study:  up to  9 Months,  Genders Eligible for Study:  Both

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.

Location Information


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

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

      San Francisco Gen Hosp, San Francisco,  California,  94110,  United States

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

      Kaiser Permanente / UCLA Med Ctr, Downey,  California,  902422814,  United States

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

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

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

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

District of Columbia
      Howard Univ Hosp, Washington,  District of Columbia,  20060,  United States

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

      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States

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

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

      Cook County Hosp, Chicago,  Illinois,  60612,  United States

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

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

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

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

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

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

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

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

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

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

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

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

      Westchester Hosp, Valhalla,  New York,  10595,  United States

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

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

      Albert Einstein College of Medicine, Bronx,  New York,  10461,  United States

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

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

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

      Lincoln Hosp Ctr, Bronx,  New York,  10451,  United States

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

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

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

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

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

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

Puerto Rico
      San Juan City Hosp, San Juan,  009367344,  Puerto Rico

Study chairs or principal investigators

E Connor,  Study Chair
G McSherry,  Study Chair

More Information

Click here for more information about Zidovudine

Study ID Numbers:  ACTG 182
Record last reviewed:  October 1996
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000750
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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