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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000750

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

400

Expected to finish

1996-09-01

Last updated by the study team

2021-10-28

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

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.
• Immunizations according to current recommendations.

Where it is running

• Univ of Alabama at Birmingham Schl of Med / Pediatrics — Birmingham, Alabama, United States
• Kaiser Permanente / UCLA Med Ctr — Downey, California, United States
• UCLA Med Ctr / Pediatric — Los Angeles, California, United States
• Harbor - UCLA Med Ctr / UCLA School of Medicine — Los Angeles, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• UCSF / Moffitt Hosp - Pediatric — San Francisco, California, United States
• Children's Hosp of Denver — Denver, Colorado, United States
• Univ of Connecticut / Farmington — Farmington, Connecticut, United States
• Yale Univ Med School — New Haven, Connecticut, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Children's Hosp of Washington DC — Washington D.C., District of Columbia, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Cook County Hosp — Chicago, Illinois, United States
• Univ of Illinois College of Medicine / Pediatrics — Chicago, Illinois, United States
• Chicago Children's Memorial Hosp — Chicago, Illinois, United States
• Univ of Chicago Children's Hosp — Chicago, Illinois, United States
• Tulane Univ / Charity Hosp of New Orleans — New Orleans, Louisiana, United States
• Univ of Maryland at Baltimore / Univ Med Ctr — Baltimore, Maryland, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States
• Univ of Massachusetts Med School — Worcester, Massachusetts, United States
• Univ of Medicine & Dentistry of New Jersey / Univ Hosp — Newark, New Jersey, United States
• Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl — Newark, New Jersey, United States
• Children's Hosp at Albany Med Ctr — Albany, New York, United States

Full record on ClinicalTrials.gov

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