HIV InfectionsNCT00000662
A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease
A study testing Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who are HIV-infected and either symptomatic or have a CD4 cell count < 400 cells/mm3 and to monitor adverse effects of AZT. Read more about this study
- Who is it for?
- Ages 3 months to 12 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Zidovudine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento May 1993
- Phase
- Interventional
- 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 3 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Concurrent Treatment:
- Allowed:
- Blood transfusions for hematologic toxicity.
- Criteria for children 3 months to less than 15 months of age:
- Patient must be HIV antibody-positive by repeated reactive screening test (e.g., ELISA) and positive confirmatory test (e.g., Western blot).
- OR
Show all 22Show fewer
- If antibody-negative, patient must have two positive p24 antigen determinations performed at least one week apart or have had a positive HIV culture.
- Patients must meet two of the following criteria:
- Be HIV culture positive or p24 antigen positive.
- Have at least one of the Class P-2 symptoms (by CDC criteria).
- Be immunosuppressed defined as having:
- CD4+(T4) lymphocytes = or < 400 cells/mm3.
- Abnormal age adjusted immunoglobulin levels (IgG or IgA). Decreased helper/suppressor ratio < 1.0.
- Note:
- In general, abnormal values for any of the above lab tests should be confirmed in 2 measurements at least 1 week apart, and other clinical causes for these abnormalities should be ruled out.
- Criteria for children 15 months to 12 years of age:
- Patient must be HIV antibody-positive by repeated reactive screening test (e.g., ELISA) and positive confirmatory test (e.g., Western blot).
- OR
- If antibody-negative, patient must have two positive p24 antigen determinations performed at least one week apart or have had a positive HIV culture.
- Patients must meet one of the following criteria:
- Have at least one of the class P-2 symptoms (by CDC criteria).
- Be immunosuppressed defined as having CD4+(T4) lymphocytes = or < 400 cells/mm3, based on two measurements at least 1 week apart.
Who cannot join
- Co-existing Condition:
- Patients with known hypersensitivity to AZT are excluded.
- Patients with the following are excluded:
- Failure to meet inclusion criteria.
- Inability to obtain signed informed consent from a parent or legal guardian.
- Enrollment in another treatment protocol that expressly prohibits concomitant treatment with zidovudine (AZT).
- Enrollment in another clinical trial in which AZT is a treatment.
- Known hypersensitivity to AZT.
Trial locations and contacts
1 site in 1 country.
United States1 site
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, 27709
About this study
To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who are HIV-infected and either symptomatic or have a CD4 cell count < 400 cells/mm3 and to monitor adverse effects of AZT.
Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT.
Read the detailed description
Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT.
This Treatment IND (investigational new drug) is an open label, uncontrolled protocol. AZT is ordered and prescribed by the patient's physician. The physician is responsible for obtaining informed consent, assuring that the patient meets the eligibility criteria, dispensing the medication to the patient, monitoring the patient's condition on treatment, and reporting required data to the project coordinating center.
- Conditions
- HIV Infections
- Being tested
- Zidovudine
- Keywords
- Drugs, Investigational, 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)
- Primary completionMay 1993
- Study completionMay 1993
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 N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Glaxo Wellcome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000662
- Sponsor's protocol ID
- TX 304
- Other IDs
- FDA 43A
- Status last verified
- Apr 1992
- First submitted
- 2 Nov 1999
- Last updated
- 31 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease
- ClinicalTrials.gov ID
- NCT00000662
- Acronym / sponsor ID
- TX 304
- Conditions
- HIV Infections
- Keywords
- Drugs, Investigational, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Glaxo Wellcome
- Primary completion
- May 1993 (actual)
- Study completion
- May 1993 (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.
To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who are HIV-infected and either symptomatic or have a CD4 cell count < 400 cells/mm3 and to monitor adverse effects of AZT.
Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT.
Detailed description
Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT.
This Treatment IND (investigational new drug) is an open label, uncontrolled protocol. AZT is ordered and prescribed by the patient's physician. The physician is responsible for obtaining informed consent, assuring that the patient meets the eligibility criteria, dispensing the medication to the patient, monitoring the patient's condition on treatment, and reporting required data to the project coordinating center.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (22 listed)
- Blood transfusions for hematologic toxicity.
- Patient must be HIV antibody-positive by repeated reactive screening test (e.g., ELISA) and positive confirmatory test (e.g., Western blot).
- OR
- If antibody-negative, patient must have two positive p24 antigen determinations performed at least one week apart or have had a positive HIV culture.
- Be HIV culture positive or p24 antigen positive.
Key exclusion criteria (8 listed)
- Patients with known hypersensitivity to AZT are excluded.
- Failure to meet inclusion criteria.
- Inability to obtain signed informed consent from a parent or legal guardian.
- Enrollment in another treatment protocol that expressly prohibits concomitant treatment with zidovudine (AZT).
- Enrollment in another clinical trial in which AZT is a treatment.
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 31 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 22 inclusion and 8 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 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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 31 Oct 2016.