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

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	Glaxo Wellcome
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000750

Purpose

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	Intervention	Phase
HIV Infections	Drug: Zidovudine	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Primary Purpose: Treatment
Official Title:	A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Zidovudine

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:	400
Primary Completion Date:	September 1996 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	up to 9 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000750

Show 42 Study Locations

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Glaxo Wellcome

Investigators

Study Chair:	E Connor
Study Chair:	G McSherry

More Information

Additional Information:

Click here for more information about Zidovudine This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00000750 History of Changes
Other Study ID Numbers:	ACTG 182
Study First Received:	November 2, 1999
Last Updated:	February 28, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 12, 2012