The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children With Mild to Moderate Symptoms
A Multicenter Placebo-Controlled Trial To Evaluate the Safety and Efficacy of Oral Zidovudine in the Treatment of Children Infected With Human Immunodeficiency Virus With Mild to Moderate Symptoms (Including LIP)
2 other identifiers
interventional
224
1 country
33
Brief Summary
To determine the safety and usefulness of zidovudine (AZT) for the treatment of children 3 months to 12 years of age. This study is designed to determine if children who are infected with HIV and who have a special type of lung disease called lymphocytic interstitial pneumonitis (LIP) or other early symptoms of HIV infection may derive benefit from treatment with AZT. It is hoped that this drug will prevent children from developing additional symptoms and infections and will help resolve already existing symptoms. AZT has been shown in the laboratory to inhibit the infection of cells by HIV. AZT has been shown to decrease the mortality and the frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. It is, therefore, likely that symptomatic HIV-infected children may also benefit from specific antiviral therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
September 1, 1992
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 1, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Prophylaxis for Pneumocystis carinii pneumonia (PCP) in children with AIDS or CD4 cell count = or \< 500 cells/mm3.
- Children must demonstrate the following clinical and laboratory findings:
- Laboratory evidence of HIV infection as demonstrated by either a positive viral culture or detectable serum p24 antigen or = or \> two positive tests for HIV antibody, which must be determined by a federally licensed ELISA test and confirmed by Western blot.
- Children \< 15 months of age, who are thought to have acquired HIV through perinatal transmission and whose only laboratory evidence of HIV infection is a positive antibody test, must also have one or more of the following laboratory criteria indicative of immunologic abnormality:
- hypergammaglobulinemia (IgG or IgA) defined as greater than the upper limit of normal for age-adjusted normals; absolute depression in the CD4+ cells to = or \< 500 cells/mm3; decreased helper/suppressor ratio \< 1.0; depressed in vitro mitogen response to at least one antigen/mitogen.
You may not qualify if:
- Hemophiliacs are included.
- Co-existing Condition:
- Children will be excluded for the following reasons:
- Recurrent or life-threatening toxicity. Several allergic reactions such as exfoliative erythroderma, anaphylaxis, or vascular collapse. The presence of one or more of the indicator diseases of AIDS, such as opportunistic infections, malignancy, recurrent bacterial infections, or encephalopathy. Development of two or more episodes of recurrent varicella zoster infection or chronic zoster defined as = or \> 30 days duration. Development of AIDS related complex, with failure to thrive, persistent or recurrent oral candidiasis, plus at least one of the following:
- Diarrhea that is either persistent or recurrent, lymphadenopathy at two or more noncontiguous sites, organomegaly, nephropathy manifested by nephrotic syndrome without evidence of renal failure, two or more episodes of herpes stomatitis or one or more episodes of herpes zoster within a 1 year period; plus at least one of the following:
- hypergammaglobulinemia, depression in the CD4+ cells to = or \< 500/mm3, decreased helper/suppressor ratio \< 1.0, depressed in vitro mitogen response to at least one antigen/mitogen.
- Concurrent Medication:
- Excluded:
- Hepatotoxic drugs.
- Steroids for lymphocytic interstitial pneumonitis (LIP).
- Prophylaxis for oral candidiasis, or otitis media.
- Immunoglobulin therapy.
- Chronic use of drugs that are metabolized by hepatic glucuronidation.
- Concurrent Treatment:
- Excluded:
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Kaiser Permanente / UCLA Med Ctr
Downey, California, 902422814, United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016, United States
Martin Luther King Jr Gen Hosp / UCLA Med Ctr
Los Angeles, California, 900593019, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004, United States
Stanford Univ School of Medicine
Menlo Park, California, 94025, United States
Children's Hosp of Oakland
Oakland, California, 946091809, United States
UCSD Treatment Ctr
San Diego, California, 92103, United States
Northern California Pediatric AIDS Treatment Ctr / UCSF
San Francisco, California, 94143, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201, United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933, United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373, United States
Beth Israel Med Ctr / Pediatrics
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Columbia Univ Babies' Hosp
New York, New York, 10032, United States
Harlem Hosp Ctr
New York, New York, 10037, United States
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, 10465, United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499, United States
Columbus Children's Hosp
Columbus, Ohio, 432052696, United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
P Weintrub
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
September 1, 1992
Last Updated
November 1, 2021
Record last verified: 2021-10