Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Glaxo Wellcome

Conditions:

HIV Infections

Eligibility:

All Genders

1-9 years

Phase:

PHASE3

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: T...

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 ...

Eligibility 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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

September 1 1996

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT00000750

End Date

September 1 1996

Last Update

October 28 2021

Active Locations (42)

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Page 1 of 11 (42 locations)

1

Univ of Alabama at Birmingham Schl of Med / Pediatrics

Birmingham, Alabama, United States, 35294

2

Kaiser Permanente / UCLA Med Ctr

Downey, California, United States, 902422814

3

UCLA Med Ctr / Pediatric

Los Angeles, California, United States, 900951752

4

Harbor - UCLA Med Ctr / UCLA School of Medicine

Los Angeles, California, United States, 905022004