HIV InfectionsPhase 3NCT00000750
A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection
A Phase 3 study testing Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 42 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 9 months
- Conditions the study is for
- HIV Infections
- What is being tested?
- Zidovudine
- How many people
- 400 participants
- Where
- 42 sitesin 2 countries
- Study dates
- Start not givento Sep 1996
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
42 sites in 2 countries.
42 sites in 2 countries
United States41 sites
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294
Children's Hosp of Boston
Boston, Massachusetts, 021155724
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, 11203
Children's Hosp Pact Prog / Children's Hosp of Buffalo
Buffalo, New York, 14222
Med Univ of South Carolina
Charleston, South Carolina, 294253312
Cook County Hosp
Chicago, Illinois, 60612
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
Columbus Children's Hosp
Columbus, Ohio, 432052696
Children's Med Ctr of Dallas
Dallas, Texas, 75235
Children's Hosp of Denver
Denver, Colorado, 802181088
Kaiser Permanente / UCLA Med Ctr
Downey, California, 902422814
Duke Univ Med Ctr
Durham, North Carolina, 277103499
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
North Shore Univ Hosp
Great Neck, New York, 11021
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
Univ of Miami (Pediatric)
Miami, Florida, 33161
Yale Univ Med School
New Haven, Connecticut, 06504
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
Metropolitan Hosp Ctr
New York, New York, 10029
Mount Sinai Med Ctr / Pediatrics
New York, New York, 10029
Harlem Hosp Ctr
New York, New York, 10037
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
Univ of Rochester Medical Center
Rochester, New York, 14642
San Francisco Gen Hosp
San Francisco, California, 94110
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
Lincoln Hosp Ctr
The Bronx, New York, 10451
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457
Albert Einstein College of Medicine
The Bronx, New York, 10461
Westchester Hosp
Valhalla, New York, 10595
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
About this study
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Zidovudine
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZidovudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionSep 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 400 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Glaxo Wellcome
- Responsible party
- Sponsor
- Investigators
- E Connor, Study chairG McSherry, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000750
- Sponsor's protocol ID
- ACTG 182
- Other IDs
- 11157
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 28 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00000750
- Acronym / sponsor ID
- ACTG 182
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Glaxo Wellcome
- Study completion
- Sep 1996 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 1 day to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
- Any agent with known antiretroviral activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zidovudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E Connor study chair
G McSherry study chair
42 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 42 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.