A Phase 1 interventional study of Zidovudine in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 2 sites in United States. Open to participants aged 3 Months to 12 Years. Per ClinicalTrials.gov, last updated 2021-11-03.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment
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Among 193 studies testing zidovudine in HIV Infections — none open to participants now, 1 under way, none of them phase 3. Zidovudine · HIV Infections.
Among the 193 studies testing zidovudine in HIV Infections, this one is the 151st largest by enrollment of the 162 interventional ones that give a count, is one of 42 in phase 1, and was the 1st registered.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
Browse HIV Infections studies →None of the 193 studies testing zidovudine in HIV Infections is open now. The open studies under HIV Infections, anywhere →
Zidovudine: first FDA approval 1987 (RETROVIR), first EMA approval 1998. What it is approved for, and how studies give it, is on its page →
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 3 Months to 12 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
193 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 44 · Phase 2 49 · Phase 3 42 · Phase 4 7
First in 1991; this study’s year is marked.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 12 is below the median of 80 across 3,491 interventional studies indexed under HIV Infections.
Median enrollment 105 across the 162 interventional studies. Of the 188 that completed or were terminated, 10 (5%) have results posted.
This tab as a report to print or save as PDF → With an account.
68 of 193 have an industry lead sponsor. The 10 most frequent:
National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 406 completed or terminated interventional studies of FDA-regulated products, 302 (74%) have results posted.
1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID): 10 open now, 15 under way, 1 of them phase 3. Of 962 finished, 130 (14%) have results posted.
Among the 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID), this one is the 789th largest by enrollment of the 883 interventional ones that give a count, is one of 365 in phase 1, and was the 1st registered.
National Institute of Allergy and Infectious Diseases (NIAID)’s HIV Infections studies by the year they started, since 1984.
None of the studies under way reaches primary completion within a year.
Among the 193 studies testing zidovudine in HIV Infections, from their registry updates:
Among National Institute of Allergy and Infectious Diseases (NIAID)’s 1,034 in HIV Infections:
This tab as a report to print or save as PDF → With an account.
The study is designed to test the drug zidovudine (AZT) in children, including study of drug levels in various parts of the body fluids, safety of the drug, and its effect on different parts of the body.
The effects of any drug, the way a drug enters the bloodstream, the way it is used by the body, and the way the body eliminates the drug may be very different in children compared with adults. The largest group of children who have AIDS are those who are less than 2 years of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT show that it might be useful in the treatment of AIDS. Thus it is important to study the effects of the drug in children.
The effects of any drug, the way a drug enters the bloodstream, the way it is used by the body, and the way the body eliminates the drug may be very different in children compared with adults. The largest group of children who have AIDS are those who are less than 2 years of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT show that it might be useful in the treatment of AIDS. Thus it is important to study the effects of the drug in children.
Patients are hospitalized for 8 weeks to receive AZT through the intravenous (IV) route at 1 of 2 doses. Patients are then discharged from hospital and take AZT by mouth for 4 more weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Concurrent Treatment:
Allowed:
Exclusion Criteria
Co-existing Condition:
Children with the following conditions are excluded:
Children with the following conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded within 4 weeks of study entry:
Child who is seropositive for antibody or has HIV viremia and presents with one or more of following clinical criteria and at least one of the laboratory criteria may be considered an ARC patient for purpose of study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zidovudine
National Institute of Allergy and Infectious Diseases (NIAID) →