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AzTrials

HIV InfectionsPhase 2NCT00000716

A Multicenter Trial To Evaluate Oral Retrovir in the Treatment of Children With Symptomatic HIV Infection

A Phase 2 study testing Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 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

To evaluate the safety and tolerance of oral zidovudine (AZT) when given over a period of 24 weeks to children between 3 months and 12 years of age. The effectiveness of AZT in treating HIV infection in infants and children will also be evaluated. 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
70 participants
Where
9 sitesUnited States
Study dates
Start not givento Jan 1991
Phase
Phase 2
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 Medication:
  • Allowed:
  • Amphotericin B and antituberculosis chemotherapy.
  • Children who have advanced lymphocytic interstitial pneumonitis (LIP) who are steroid dependent may remain on such therapy.
  • Secondary prophylaxis for Pneumocystis carinii pneumonia (PCP) with careful monitoring for possible toxicity due to combination therapy with zidovudine (AZT).
  • Concurrent Treatment:
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  • Allowed:
  • Blood transfusions for hematologic toxicity.
  • Immunoglobulin therapy for development of = or > 3 serious bacterial infections while receiving zidovudine. A serious bacterial infection includes septicemia (not catheter related), pneumonia, meningitis, bone or joint infection, or abscess of the body cavity or internal organ.
  • The pathogen must be one of the following organisms:
  • Staphylococcus aureus, Streptococcus pyogenes, Escherichia coli, Streptococcus group B, Pseudomonas aeruginosa, Hemophilus influenzae B, and Pneumococcus. Laboratory documentation of the pathogen is required.
  • Patients must comply with the following:
  • Life expectancy of more than 6 months.
  • Children must have laboratory evidence of HIV infections as demonstrated by either a positive viral culture or detectable serum p24 antigen or repeated positive test for HIV antibody determined by a federally licensed ELISA test and confirmed by Western blot.
  • Children under 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 increased immunoglobulin levels and decreased absolute number of CD4+ cells or a decreased helper/suppressor ratio.
  • AIDS:
  • Must have clinical evidence of HIV infection as demonstrated by the presence of one or more of the indicator diseases as defined in the CDC Surveillance definition for AIDS. (NOTE:
  • Children with lymphocytic interstitial pneumonitis are excluded unless they meet at least one of the following conditions:
  • an additional AIDS-defining opportunistic infection, recurrent serious bacterial infection, HIV encephalopathy, wasting syndrome, or meet the definition of AIDS related complex (ARC).
  • ARC:
  • Children who present with at least one of the first three clinical findings and one of any other listed below within 2 months of entry or who present with two of the first three symptoms listed:
  • <= 500 CD4 cells/mm3 within 4 weeks of entry, persistent (>= 2 months) or recurrent oral candidiasis despite therapy, diarrhea (defined as >= 3 loose stools per day) that is either persistent or recurrent, hepatomegaly, splenomegaly, cardiomyopathy, nephropathy manifested by nephrotic syndrome without evidence of renal failure, 2 or more episodes of herpes stomatitis within a 1-year period, or 2 or more episodes of recurrent herpes zoster or chronic zoster (defined as = or > 30 days duration regardless of therapy).
  • Written informed consent from a parent or guardian.

Who cannot join

  • Co-existing Condition:
  • Patients with the following will be excluded:
  • Any active or chronic opportunistic infection at time of entry requiring acute therapy with experimental agents or agents which may affect zidovudine (AZT) toxicity or safety, nor serious bacterial, fungal, or parasitic infections requiring parenteral therapy at the time of entry.
  • Concurrent Medication:
  • Concomitant medications should be kept to a minimum.
  • Excluded:
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  • Chronic use of drugs that are metabolized by hepatic glucuronidation, such as acetaminophen.
  • Acute therapy for active or chronic opportunistic infection with experimental agents or agents which may affect zidovudine (AZT) toxicity.
  • Parenteral therapy for serious bacterial, fungal, or parasitic infections.
  • Prophylaxis for Pneumocystis carinii pneumonia (PCP) for children who have not had a previous episode of PCP, oral candidiasis, or otitis media.
  • Immunoglobulin therapy. Note: Immunoglobulin therapy may be administered to children who develop = > 3 serious bacterial infections while receiving AZT.
  • Children with lymphocytic interstitial pneumonitis (LIP) as their only clinical sign of HIV infection will be excluded from the study. Children with any of the following laboratory findings within 2 weeks of entry will be excluded:
  • A total bilirubin > 3 times Upper Limit of Normal (ULN).
  • SGOT > 5 x Upper Limit of Normal in the presence of an age-adjusted abnormal bilirubin.
  • Creatinine clearance < 50 ml/min/1.73 m2.
  • White blood cells < 2000 cells/mm3.
  • Neutrophils < 800 cells/mm3.
  • Hematocrit < 24 percent.
  • Hemoglobin < 8.0 g /dl.
  • Children who will be unable to be followed by their original study center for the 24 weeks of the study will be excluded.
  • Prior Medication:
  • Excluded within 2 weeks of study entry:
  • Any other experimental therapy or drugs which cause prolonged neutropenia or significant nephrotoxicity.
  • Excluded within 4 weeks of study entry:
  • Immunomodulating agents including steroids, interferon, isoprinosine, and interleukin-2.
  • Excluded within 2 months of study entry:
  • Other antiretroviral agents.
  • Note: Children with advanced lymphocytic interstitial pneumonitis (LIP) who are steroid dependent may remain on such therapy.
  • Prior Treatment:
  • Excluded within 4 weeks of study entry:
  • Immunoglobulin.
  • Lymphocyte transfusions for immune reconstitution.
  • Excluded within 3 months of study entry:
  • Bone marrow transplant.
  • Active alcohol or drug abuse.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Johns Hopkins Hosp - Pediatric

    Baltimore, Maryland, 212874933

  • Johns Hopkins Hosp

    Baltimore, Maryland, 21287

  • Children's Hosp of Boston

    Boston, Massachusetts, 021155724

  • Duke Univ Med Ctr

    Durham, North Carolina, 27710

  • Los Angeles County - USC Med Ctr

    Los Angeles, California, 90033

  • Univ of Miami School of Medicine

    Miami, Florida, 331361013

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York, 10016

  • Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl

    Newark, New Jersey, 071072198

  • San Francisco AIDS Clinic / San Francisco Gen Hosp

    San Francisco, California, 941102859

Other trials in United States

About this study

To evaluate the safety and tolerance of oral zidovudine (AZT) when given over a period of 24 weeks to children between 3 months and 12 years of age. The effectiveness of AZT in treating HIV infection in infants and children will also be evaluated.

HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in altering the course of the disease and decreasing mortality in these children. AZT has been shown to be effective in certain adult patients with symptomatic HIV infection. It is therefore likely that infected children may also benefit from this treatment.

Read the detailed description

HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in altering the course of the disease and decreasing mortality in these children. AZT has been shown to be effective in certain adult patients with symptomatic HIV infection. It is therefore likely that infected children may also benefit from this treatment.

The participants receive AZT mixed with juice at a dose dependent on body size every 6 hours for 24 weeks. The children are evaluated weekly for the first 4 weeks, every two weeks for the subsequent 8 weeks, and monthly thereafter. Blood samples are collected periodically and cerebrospinal fluid (CSF) by lumbar puncture on 2 occasions.

Conditions
HIV Infections
Being tested
Zidovudine
Keywords
Drug Evaluation, Administration, Oral, Acquired Immunodeficiency Syndrome, Zidovudine
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

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. Primary completionJan 1991

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 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
70 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000716
Sponsor's protocol ID
ACTG 043
Other IDs
NCI-T88-0191N, Protocol 26,341--08, Project P53, FDA 9C
Status last verified
May 1990
First submitted
2 Nov 1999
Last updated
14 Mar 2011
Results posted
No

Publications

  • McKinney RE Jr, Wilfert C. Growth as a prognostic indicator in children with human immunodeficiency virus infection treated with zidovudine. AIDS Clinical Trials Group Protocol 043 Study Group. J Pediatr. 1994 Nov;125(5 Pt 1):728-33. doi: 10.1016/s0022-3476(94)70065-6.

    PubMed 7965424

  • McKinney RE Jr, Maha MA, Connor EM, Feinberg J, Scott GB, Wulfsohn M, McIntosh K, Borkowsky W, Modlin JF, Weintrub P, et al. A multicenter trial of oral zidovudine in children with advanced human immunodeficiency virus disease. The Protocol 043 Study Group. N Engl J Med. 1991 Apr 11;324(15):1018-25. doi: 10.1056/NEJM199104113241503.

    PubMed 1672443

  • Connor E. Lymphocyte subset changes in children with advanced symptomatic HIV infection treated with oral zidovudine. Int Conf AIDS. 1990 Jun 20-23;6(2):95 (abstract no FB21)

  • Kavanaugh-McHugh A, Ruff A, Rowe S, Holt E, Modlin J, Maha M, Wilfert C. Cardiac abnormalities in pediatric HIV infection. Int Conf AIDS. 1990 Jun 20-23;6(2):198 (abstract no FB483)

  • McKinney RE, Wilfert CM. The efficacy of oral, intermittent zidovudine (ZDV) in a phase II pediatric trial (AIDS clinical trials group study 043). Int Conf AIDS. 1990 Jun 20-23;6(2):94 (abstract no FB18)

  • McKinney RS. Markers prognostic for survival in zidovudine treated, HIV infected children. ACTG Protocol 043 Study Group. American Pediatric Society 104th annual meeting and Society for Pediatric Research 63rd annual meeting; 1994 May 2-5; Seattle. Pediatr AIDS HIV Infect. 1994 Oct;5(5):323 (unnumbered abstract)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 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 23 inclusion and 35 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 14 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 NCT00000716, which also lists 6 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 14 Mar 2011.

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