AzTrials
AzTrials

HIV InfectionsPhase 3NCT00000637

A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children

A Phase 3 study testing Zidovudine and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 80 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

To compare the effectiveness of treatment with zidovudine (AZT) compared to didanosine (ddI) and compared to the combination of AZT and ddI as determined by survival and disease progression. Read more about this study

Who is it for?
Ages 3 months to 17 years
Conditions the study is for
HIV Infections
What is being tested?
Zidovudine and Didanosine
How many people
819 participants
Where
80 sitesin 2 countries
Study dates
Start not givento Sep 1996
Phase
Phase 3
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 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Concurrent Medication:
  • Allowed:
  • Acetaminophen, ibuprofen, or aspirin, but not on a continual basis for > 72 hours.
  • Systemic ketoconazole and fluconazole for acute therapy.
  • Recommended:
  • Prophylaxis for PCP. (Primary prophylaxis with TMP / SMX is encouraged.) IV pentamidine may be used in selected cases if not administered on a weekly basis.
Show all 12Show fewer
  • Patients must have the following:
  • HIV infection.
  • Children randomized prior to their eighteenth birthday are eligible. Co-enrollment in either ACTG 179 or 189 is permitted.
  • Prior Medication:
  • Allowed:
  • Up to six weeks of antiretroviral or immunomodulator treatment excluding steroids and intravenous immunoglobulin.

Who cannot join

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Active malignancy.
  • Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms.
  • History of uncontrolled seizure disorder.
  • Grade 3 or higher peripheral neuropathy.
Show all 28Show fewer
  • Cardiomyopathy.
  • Concurrent Medication:
  • Excluded:
  • Chemotherapy for malignancy.
  • Oral acidifying agents.
  • Acetaminophen, ibuprofen, or aspirin on a continual basis for > 72 hours.
  • Ketoconazole or fluconazole for prophylaxis.
  • Drugs with potential to cause peripheral neuropathy or pancreatitis should not be given daily for > 4 weeks.
  • Patients with the following are excluded:
  • Active malignancy.
  • Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms.
  • History of uncontrolled seizure disorder.
  • Grade 3 or higher peripheral neuropathy.
  • Prior Medication:
  • Excluded:
  • Steroids.
  • Intravenous immunoglobulin.
  • Antiretroviral drugs or specific immunomodulator treatment (excluding steroids and intravenous immunoglobulin) for > 6 weeks and within 7 days prior to study entry.
  • Prior Treatment:
  • Excluded:
  • Red blood cell transfusion within four weeks prior to study entry.
  • Ongoing drug or alcohol use.

Trial locations and contacts

80 sites in 2 countries.

80 sites in 2 countries

United States76 sites

  • Children's Hosp at Albany Med Ctr

    Albany, New York, 12208

  • Emory Univ Hosp / Pediatrics

    Atlanta, Georgia, 30306

  • Univ of Maryland at Baltimore / Univ Med Ctr

    Baltimore, Maryland, 21201

  • Johns Hopkins Hosp - Pediatric

    Baltimore, Maryland, 212874933

  • Univ of Alabama at Birmingham Schl of Med / Pediatrics

    Birmingham, Alabama, 35294

  • Children's Hosp of Boston

    Boston, Massachusetts, 021155724

  • Boston City Hosp / Pediatrics

    Boston, Massachusetts, 02118

  • King's County Hosp Ctr / Pediatrics

    Brooklyn, New York, 11203

  • SUNY - Brooklyn

    Brooklyn, New York, 11203

  • SUNY / Health Sciences Ctr at Brooklyn / Pediatrics

    Brooklyn, New York, 11203

  • Children's Hosp Pact Prog / Children's Hosp of Buffalo

    Buffalo, New York, 14222

  • Univ of North Carolina

    Chapel Hill, North Carolina, 275997215

  • Med Univ of South Carolina

    Charleston, South Carolina, 29425

  • Cook County Hosp

    Chicago, Illinois, 60612

  • Univ of Illinois College of Medicine / Pediatrics

    Chicago, Illinois, 60612

  • Chicago Children's Memorial Hosp

    Chicago, Illinois, 606143394

  • Univ of Chicago Children's Hosp

    Chicago, Illinois, 606371470

  • Cincinnati Children's Hosp / Univ Hosp

    Cincinnati, Ohio, 452292899

  • Case Western Reserve Univ

    Cleveland, Ohio, 44106

  • Columbus Children's Hosp

    Columbus, Ohio, 432052696

  • Children's Med Ctr of Dallas

    Dallas, Texas, 75235

  • Children's Hosp of Denver

    Denver, Colorado, 802181088

  • Children's Hosp of Michigan

    Detroit, Michigan, 48201

  • Kaiser Permanente / UCLA Med Ctr

    Downey, California, 902422814

  • Duke Univ Med Ctr

    Durham, North Carolina, 277103499

  • Univ of Connecticut Health Ctr

    Farmington, Connecticut, 06032

  • North Shore Univ Hosp

    Great Neck, New York, 11021

  • Hermann Hosp / Univ Texas Health Science Ctr

    Houston, Texas, 77030

  • Texas Children's Hosp / Baylor Univ

    Houston, Texas, 77030

  • UCSD Med Ctr / Pediatrics / Clinical Sciences

    La Jolla, California, 920930672

  • Long Beach Memorial (Pediatric)

    Long Beach, California, 90801

  • Los Angeles County - USC Med Ctr

    Los Angeles, California, 90033

  • Cedars Sinai / UCLA Med Ctr

    Los Angeles, California, 900481804

  • UCLA Med Ctr / Pediatric

    Los Angeles, California, 900951752

  • Harbor - UCLA Med Ctr / UCLA School of Medicine

    Los Angeles, California, 905022004

  • Saint Jude Children's Research Hosp of Memphis

    Memphis, Tennessee, 381052794

  • Univ of Miami (Pediatric)

    Miami, Florida, 33161

  • UMDNJ - Robert Wood Johnson Med School / Pediatrics

    New Brunswick, New Jersey, 089030019

  • Robert Wood Johnson Med School / Hershey Med Ctr

    New Brunswick, New Jersey, 08903

  • Yale Univ Med School

    New Haven, Connecticut, 06504

  • Schneider Children's Hosp

    New Hyde Park, New York, 11040

  • Beth Israel Med Ctr / Pediatrics

    New York, New York, 10003

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York, 10016

  • Cornell Univ Med College

    New York, New York, 10021

  • Saint Luke's - Roosevelt Hosp Ctr

    New York, New York, 10025

  • Metropolitan Hosp Ctr

    New York, New York, 10029

  • Mount Sinai Med Ctr / Pediatrics

    New York, New York, 10029

  • Columbia Presbyterian Med Ctr

    New York, New York, 10032

  • Incarnation Children's Ctr / Columbia Presbyterian Med Ctr

    New York, New York, 10032

  • Harlem Hosp Ctr

    New York, New York, 10037

  • Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl

    Newark, New Jersey, 07103

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

    Newark, New Jersey, 071072198

  • Children's Hosp of Oakland

    Oakland, California, 946091809

  • Huntington Memorial Hosp / Children's Hosp of Los Angeles

    Pasadena, California, 91105

  • Children's Hosp of Philadelphia

    Philadelphia, Pennsylvania, 191044318

  • Saint Christopher's Hosp for Children

    Philadelphia, Pennsylvania, 191341095

  • Hemophilia Ctr of Western PA / Univ of Pittsburgh

    Pittsburgh, Pennsylvania, 15219

  • Rhode Island Hosp / Brown Univ

    Providence, Rhode Island, 02903

  • Univ of Rochester Medical Center

    Rochester, New York, 14642

  • Univ of California / San Diego Treatment Ctr

    San Diego, California, 921036325

  • UCSF / Moffitt Hosp - Pediatric

    San Francisco, California, 941430105

  • Children's Hosp of Seattle

    Seattle, Washington, 98105

  • Baystate Med Ctr of Springfield

    Springfield, Massachusetts, 01199

  • St Louis Univ School of Medicine

    St Louis, Missouri, 63104

  • Stanford Univ School of Medicine / Pediatrics

    Stanford, California, 943054149

  • State Univ of New York at Stony Brook

    Stony Brook, New York, 117948111

  • SUNY Health Sciences Ctr at Syracuse / Pediatrics

    Syracuse, New York, 13210

  • Lincoln Hosp Ctr

    The Bronx, New York, 10451

  • Bronx Lebanon Hosp Ctr / Pediatrics

    The Bronx, New York, 10457

  • Bronx Lebanon Hosp Ctr

    The Bronx, New York, 10457

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Westchester Hosp

    Valhalla, New York, 10595

  • Georgetown Univ Med Ctr

    Washington D.C., District of Columbia, 200072197

  • Children's Hosp of Washington DC

    Washington D.C., District of Columbia, 200102916

  • Howard Univ Hosp

    Washington D.C., District of Columbia, 20060

  • Univ of Massachusetts Med Ctr

    Worcester, Massachusetts, 01655

Other trials in United States

Puerto Rico4 sites

  • Ramon Ruiz Arnau Univ Hosp / Pediatrics

    Bayamón, 00956

  • Univ of Puerto Rico / Univ Children's Hosp AIDS

    San Juan, 009365067

  • UPR Children's Hosp / UPR School of Medicine

    San Juan, 009365067

  • San Juan City Hosp

    San Juan, 009367344

Other trials in Puerto Rico

About this study

To compare the effectiveness of treatment with zidovudine (AZT) compared to didanosine (ddI) and compared to the combination of AZT and ddI as determined by survival and disease progression. To compare the relative safety and tolerance of AZT versus ddI versus AZT plus ddI in symptomatic HIV infected children; to compare the virological and immunological parameters in the three treatment groups. AZT has been shown to delay the progression of AIDS in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect. Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment, but later have progression of the disease. Thus, new drug treatments are needed. Studies of ddI in adults and children indicate some effectiveness of the drug. A direct comparison of AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT plus ddI) may give added therapeutic benefit to children.

Read the detailed description

AZT has been shown to delay the progression of AIDS in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect. Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment, but later have progression of the disease. Thus, new drug treatments are needed. Studies of ddI in adults and children indicate some effectiveness of the drug. A direct comparison of AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT plus ddI) may give added therapeutic benefit to children.

Patients are placed by random selection into one of three groups to receive either AZT alone, ddI alone, or AZT and ddI. This is a double-blind study: neither patient nor treating physician knows which group patient is in. If patients are receiving either AZT or ddI alone and they develop drug toxicity (after dose reduction), or if HIV disease progresses, the alternative single drug is offered. If patients receiving both drugs develop drug toxicity (despite dose reduction) or if HIV disease progresses, they discontinue study drug and are offered the best alternative therapy. PER AMENDMENT 6/26/95: Initial monotherapy AZT arm is unblinded and no further crossover therapy for any arm is permitted. Patients who reach crossover criteria on initial blinded ddI or AZT+ddI will be unblinded and permanently discontinued from study drugs.

Conditions
HIV Infections
Being tested
Zidovudine, Didanosine
Keywords
Didanosine, Drug Evaluation, Drug Therapy, Combination, 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 completionSep 1996

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 3
Primary purpose
Treatment
Masking
Double blind
Enrolment
819 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000637
Sponsor's protocol ID
ACTG 152
Other IDs
11127
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
2 Nov 2021
Results posted
No

Publications

  • Raskino C, Pearson DA, Baker CJ, Lifschitz MH, O'Donnell K, Mintz M, Nozyce M, Brouwers P, McKinney RE, Jimenez E, Englund JA. Neurologic, neurocognitive, and brain growth outcomes in human immunodeficiency virus-infected children receiving different nucleoside antiretroviral regimens. Pediatric AIDS Clinical Trials Group 152 Study Team. Pediatrics. 1999 Sep;104(3):e32. doi: 10.1542/peds.104.3.e32.

    PubMed 10469815

  • Grubman S. Pediatric treatment update. GMHC Treat Issues. 1996 Mar;10(3):7-9.

    PubMed 11363392

  • Glick ME. CTG studies yield results. AIDS Clinical Trials Group. NIAID AIDS Agenda. 1995 Spring:8-9.

    PubMed 11362451

  • Rogers MF, Mofenson LM, Moseley RR. Reducing the risk of perinatal HIV transmission through zidovudine therapy: treatment recommendations and implications. J Am Med Womens Assoc (1972). 1995 May-Aug;50(3-4):78-82, 93.

    PubMed 7657952

  • Nielsen K, Wei LS, Sim MS, Deveikis A, Keller M, Stiehm ER, Frenkel LM, Bryson YJ. Correlation of clinical progression in human immunodeficiency virus-infected children with in vitro zidovudine resistance measured by a direct quantitative peripheral blood lymphocyte assay. J Infect Dis. 1995 Aug;172(2):359-64. doi: 10.1093/infdis/172.2.359.

    PubMed 7622878

  • Palumbo PE, Raskino C, Fiscus S, Pahwa S, Fowler MG, Spector SA, Englund JA, Baker CJ. Predictive value of quantitative plasma HIV RNA and CD4+ lymphocyte count in HIV-infected infants and children. JAMA. 1998 Mar 11;279(10):756-61. doi: 10.1001/jama.279.10.756.

    PubMed 9508151

  • 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

  • James JS. AZT, ddI, and ddC combinations at FDA advisory hearing. Food and Drug Administration. AIDS Treat News. 1996 Apr 5;(no 244):6.

    PubMed 11363307

  • Englund JA, Baker CJ, McKinney RE, Raskino CL, Fowler MG, Lifschitz MC. Results of ACTG 152, a randomized comparative trial of zidovudine (ZDV), didanosine (ddI), and ZDV/ddI combination therapy in symptomatic HIV-infected children. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1996 Sep 15-18:213 (abstract no I150)

  • Englund JA, Baker CJ, Raskino C, McKinney RE, Petrie B, Fowler MG, Pearson D, Gershon A, McSherry GD, Abrams EJ, Schliozberg J, Sullivan JL. Zidovudine, didanosine, or both as the initial treatment for symptomatic HIV-infected children. AIDS Clinical Trials Group (ACTG) Study 152 Team. N Engl J Med. 1997 Jun 12;336(24):1704-12. doi: 10.1056/NEJM199706123362403.

    PubMed 9182213

  • Capparelli EV, Englund JA, Connor JD, Spector SA, McKinney RE, Palumbo P, Baker CJ. Population pharmacokinetics and pharmacodynamics of zidovudine in HIV-infected infants and children. J Clin Pharmacol. 2003 Feb;43(2):133-40. doi: 10.1177/0091270002239821.

    PubMed 12616665

  • Chantry CJ, Byrd RS, Englund JA, Baker CJ, McKinney RE Jr; Pediatric AIDS Clinical Trials Group Protocol 152 Study Team. Growth, survival and viral load in symptomatic childhood human immunodeficiency virus infection. Pediatr Infect Dis J. 2003 Dec;22(12):1033-9. doi: 10.1097/01.inf.0000100575.64298.bc.

    PubMed 14688560

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zidovudine and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 80 sites in 2 countries.

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 12 inclusion and 28 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 2 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 80 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 NCT00000637, which also lists 12 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 2 Nov 2021.

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