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AzTrials

HIV InfectionsPhase 1NCT00000701

A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)

A Phase 1 study testing Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. 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
12 participants
Where
2 sitesUnited States
Study dates
Start not givento Feb 1990
Phase
Phase 1
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:
  • Nutritional support not exceeding 120 calories/kg/day (hyperalimentation or dietary supplements including vitamin, folate, iron supplements).

Who cannot join

  • Co-existing Condition:
  • Children with the following conditions are excluded:
  • Asymptomatic with T-lymphocyte deficiency.
  • Asymptomatic viremic patients or those not meeting definition criteria of AIDS related complex (ARC) or AIDS.
  • Clinical evidence of active infection of acute nature or active significant or clinically apparent opportunistic infection at time of entry into study.
  • Hemoglobinopathy including sickle cell anemia.
Show all 50Show fewer
  • Congenital infections such as toxoplasmosis or herpes simplex virus infection in the first month after birth or cytomegalovirus infection in the first 6 months after birth.
  • Children with the following conditions are excluded:
  • Asymptomatic with T-lymphocyte deficiency.
  • Asymptomatic viremic patients or those not meeting definition criteria of AIDS related complex (ARC) or AIDS.
  • Clinical evidence of active infection of acute nature or active significant or clinically apparent opportunistic infection at time of entry into study.
  • Hemoglobinopathy including sickle cell anemia.
  • Congenital infections such as toxoplasmosis or herpes simplex virus infection in the first month after birth or cytomegalovirus infection in the first 6 months after birth.
  • Prior Medication:
  • Excluded:
  • Suramin.
  • Ribavirin.
  • HPA 23.
  • Phosphonoformate.
  • Ansamycin.
  • Interleukin 2.
  • Interferon.
  • Excluded within 30 days of study entry:
  • All cytolytic chemotherapeutic agents, immunomodulating agents including steroids and immunoglobulin preparations.
  • Antivirals (acyclovir, ganciclovir).
  • Prior Treatment:
  • Excluded within 4 weeks of study entry:
  • Lymphocyte transfusions for immune reconstitution.
  • Excluded within 3 months of study entry:
  • Bone marrow transplant.
  • Child who is seropositive for HIV 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:
  • Clinical criteria:
  • Persistent oral candidiasis despite appropriate therapy.
  • Wasting syndrome characterized by failure to thrive and malnutrition.
  • Recurrent or chronic unexplained diarrhea.
  • Lymphadenopathy (more than 1 cm) at 2 or more noncontiguous sites.
  • Hepatomegaly with or without splenomegaly.
  • Encephalopathy with loss of developmental milestones and cortical atrophy present on computed tomography (CT) examination.
  • Recurrent bacterial infections (bacteremia, pneumonia, septic arthritis, meningitis).
  • Cutaneous anergy as defined by lack of delayed cutaneous hypersensitivity to selected antigens.
  • Laboratory criteria:
  • Hypergammaglobulinemia (IgG or IgA) defined as immunoglobulin values exceeding the maximum age-adjusted level.
  • Decreased number of total T-lymphocytes (2 SD from mean).
  • Absolute depression in T-helper cells to less than 500/mm3.
  • Depressed (equal to or more than 2 SD from normal mean) in vitro mitogen response to at least one antigen.
  • One positive HIV culture within 3 months of study entry into the study or blood obtained and culture pending.
  • Life expectancy greater than 6 months.
  • Ambulatory and free of opportunistic infection at time of entry.
  • Reliably diagnosed disease at least moderately indicative of underlying cellular immunodeficiency and no known cause of underlying cellular immunodeficiency or other reduced resistance reported to be associated with that disease.
  • Disease accepted as sufficiently indicative of underlying cellular immunodeficiency by CDC. In absence of these opportunistic diseases, a histologically confirmed diagnosis of chronic lymphoid interstitial pneumonitis will be considered indicative of AIDS unless test(s) for HIV are negative.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Duke Univ Med Ctr

    Durham, North Carolina, 27710

  • Univ of Miami School of Medicine

    Miami, Florida, 331361013

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions
HIV Infections
Being tested
Zidovudine
Keywords
Drug Evaluation, 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionFeb 1990

Resources

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 1
Primary purpose
Treatment
Masking
None (open label)
Enrolment
12 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000701
Sponsor's protocol ID
ACTG 003
Other IDs
Protocol 26,541-004, Project p53, 10979
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
3 Nov 2021
Results posted
No

Publications

  • Walter EB, Weinhold KJ, Wilfert CM. Enhanced p24 antigen detection in sera from human immunodeficiency virus-infected children. Pediatr Infect Dis J. 1993 Jan;12(1):94-6. doi: 10.1097/00006454-199301000-00019. No abstract available.

    PubMed 8417433

  • McKinney RE Jr, Pizzo PA, Scott GB, Parks WP, Maha MA, Lehrman SN, Riggs M, Eddy J, Lane BA, Eppes SC, et al. Safety and tolerance of intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients. Pediatric Zidovudine Phase I Study Group. J Pediatr. 1990 Apr;116(4):640-7. doi: 10.1016/s0022-3476(05)81619-1.

    PubMed 2181102

  • Dolin R, Graham BS, Greenberg SB, Tacket CO, Belshe RB, Midthun K, Clements ML, Gorse GJ, Horgan BW, Atmar RL, et al. The safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-1) recombinant gp160 candidate vaccine in humans. NIAID AIDS Vaccine Clinical Trials Network. Ann Intern Med. 1991 Jan 15;114(2):119-27. doi: 10.7326/0003-4819-114-2-119.

    PubMed 1984386

  • Mitchell C, Scott G, Hutto C, Mastrucci T, Gourley J, Owens C, Sajous M. Safety and tolerance of zidovudine in pediatric AIDS. Int Conf AIDS. 1990 Jun 20-23;6(2):200 (abstract no FB488)

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites 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 3 inclusion and 50 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

On the ClinicalTrials.gov record for NCT00000701, which also lists 4 linked publications.

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 3 Nov 2021.

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