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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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