A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection - Article Azidothymidine Capsule; AZT Capsule; Compound S Capsule; Retrovir Capsule
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.
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
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.
Ages Eligible for Study: up to 9 Months, Genders Eligible for Study: Both
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.
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.
- PCP prophylaxis.
- Immunizations according to current recommendations.
Univ of Alabama at Birmingham Schl of Med / Pediatrics, Birmingham, Alabama, 35294, United States
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
Children's Hosp of Denver, Denver, Colorado, 802181088, United States
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
Univ of Miami (Pediatric), Miami, Florida, 33161, United States
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
Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana, 701122699, United States
Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore, Maryland, 21201, United States
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
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
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
Duke Univ Med Ctr, Durham, North Carolina, 277103499, United States
Columbus Children's Hosp, Columbus, Ohio, 432052696, United States
Med Univ of South Carolina, Charleston, South Carolina, 294253312, United States
Saint Jude Children's Research Hosp of Memphis, Memphis, Tennessee, 381052794, United States
Children's Med Ctr of Dallas, Dallas, Texas, 75235, United States
San Juan City Hosp, San Juan, 009367344, Puerto Rico
E Connor, Study Chair
G McSherry, Study Chair
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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
Cache Date: April 9, 2005