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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00000750

Enrollment

400

Registered

2001-08-31

Start date

Unknown

Completion date

1996-09-30

Last updated

2021-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine

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: 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.

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 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.

Interventions

DRUGZidovudine

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

1 Days to 9 Months

Healthy volunteers

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.

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026