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HIV InfectionsPhase 2NCT00000963

A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine

A Phase 2 study testing Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 52 sites in 2 countries.

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 effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the treatment of children with symptomatic HIV disease who have had to discontinue zidovudine (AZT) because of intolerance and/or who have experienced progressive disease while on AZT. Read more about this study

Who is it for?
Ages 3 months to 18 years
Conditions the study is for
HIV Infections
What is being tested?
Didanosine
How many people
300 participants
Where
52 sitesin 2 countries
Study dates
Start not givento Sep 1995
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 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Concurrent Medication:
  • Allowed:
  • Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).
  • Immunoglobulin.
  • Maintenance therapy with amphotericin B (l mg/kg) up to 5 days/week.
  • Concurrent Treatment:
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  • Allowed:
  • Blood transfusions.
  • Prior Medication:
  • Allowed:
  • Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).
  • Patients enrolled in ACTG 128 and ACTG 138 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this study.
  • Patients currently enrolled in ACTG 051 who have not reached the study end points but who meet the entry criteria for ACTG 144 may be co-enrolled in ACTG 144.
  • Patient or guardian available to give written informed consent.

Who cannot join

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded.
  • Hypersensitivity to didanosine (ddI).
  • Symptomatic cardiomyopathy.
  • Seizures that are not well controlled by ongoing anticonvulsant therapy.
  • Symptomatic pancreatitis.
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  • Grade 1 or higher peripheral neuropathy.
  • Active malignancy requiring chemotherapy.
  • Concurrent Medication:
  • Excluded:
  • Zidovudine (AZT), other antiretroviral agents, biological modifiers, and investigational medications.
  • Avoid:
  • Drugs with potential to cause peripheral neuropathy or pancreatitis.
  • Patients with the following are excluded:
  • Active malignancy requiring concomitant chemotherapy.
  • Prior Medication:
  • Excluded:
  • Antiretroviral agents other than zidovudine (AZT) or dideoxycytidine (ddC) within 4 weeks of study entry.
  • Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry.
  • Any other experimental therapy within 1 week of entry.
  • Drugs that have or will cause prolonged neutropenia, significant pancreatitis, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.

Trial locations and contacts

52 sites in 2 countries.

52 sites in 2 countries

United States49 sites

  • Children's Hospital at Albany Medical Center, Dept. of Peds.

    Albany, New York, 12208

  • Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases

    Atlanta, Georgia, 30306

  • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology

    Baltimore, Maryland, 21201

  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

    Baltimore, Maryland, 21287

  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases

    Boston, Massachusetts, 02115

  • BMC, Div. of Ped Infectious Diseases

    Boston, Massachusetts, 02118

  • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS

    Brooklyn, New York, 11203

  • Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases

    Charleston, South Carolina, 29425

  • Cook County Hosp.

    Chicago, Illinois, 60612

  • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.

    Chicago, Illinois, 60612

  • Chicago Children's CRS

    Chicago, Illinois, 60614

  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease

    Chicago, Illinois, 60637

  • Case CRS

    Cleveland, Ohio, 44106

  • Children's Med. Ctr. Dallas

    Dallas, Texas, 75235

  • Children's Hospital of Michigan NICHD CRS

    Detroit, Michigan, 48201

  • DUMC Ped. CRS

    Durham, North Carolina, 27710

  • Univ. of Connecticut Health Ctr., Dept. of Ped.

    Farmington, Connecticut, 06032

  • North Shore-Long Island Jewish Health System, Dept. of Peds.

    Great Neck, New York, 11021

  • Texas Children's Hosp. CRS

    Houston, Texas, 77030

  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.

    Long Beach, California, 90801

  • Usc La Nichd Crs

    Los Angeles, California, 90033

  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

    Los Angeles, California

  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS

    Miami, Florida, 33161

  • UMDNJ - Robert Wood Johnson

    New Brunswick, New Jersey

  • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease

    New Haven, Connecticut, 06504

  • Schneider Children's Hosp., Div. of Infectious Diseases

    New Hyde Park, New York, 11040

  • Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU

    New Orleans, Louisiana

  • Tulane/LSU Maternal/Child CRS

    New Orleans, Louisiana

  • NYU Med. Ctr., Dept. of Medicine

    New York, New York, 10016

  • Metropolitan Hosp. NICHD CRS

    New York, New York, 10029

  • Columbia IMPAACT CRS

    New York, New York, 10032

  • Incarnation Children's Ctr.

    New York, New York, 10032

  • Harlem Hosp. Ctr. NY NICHD CRS

    New York, New York, 10037

  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

    Oakland, California, 94609

  • St. Joseph's Hosp. & Med. Ctr. of New Jersey

    Paterson, New Jersey

  • The Children's Hosp. of Philadelphia IMPAACT CRS

    Philadelphia, Pennsylvania, 19104

  • St. Christopher's Hosp. for Children

    Philadelphia, Pennsylvania, 19134

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642

  • UCSD Maternal, Child, and Adolescent HIV CRS

    San Diego, California, 92093

  • UCSF Pediatric AIDS CRS

    San Francisco, California, 94143

  • UW School of Medicine - CHRMC

    Seattle, Washington, 98105

  • Baystate Health, Baystate Med. Ctr.

    Springfield, Massachusetts, 01199

  • SUNY Stony Brook NICHD CRS

    Stony Brook, New York, 11794

  • SUNY Upstate Med. Univ., Dept. of Peds.

    Syracuse, New York, 13210

  • Bronx-Lebanon Hosp. IMPAACT CRS

    The Bronx, New York, 10457

  • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases

    Torrance, California

  • Children's National Med. Ctr., ACTU

    Washington D.C., District of Columbia, 20010

  • Howard Univ. Washington DC NICHD CRS

    Washington D.C., District of Columbia, 20060

  • WNE Maternal Pediatric Adolescent AIDS CRS

    Worcester, Massachusetts, 01655

Other trials in United States

Puerto Rico3 sites

  • Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.

    Bayamón, 00956

  • San Juan City Hosp. PR NICHD CRS

    San Juan, 00936

  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Randomized Comparative Trial of Two Doses of 2',3'-Dideoxyinosine (ddI) in Children With Symptomatic HIV Infection Who Are Either Unresponsive to Zidovudine and/or Who Are Intolerant to Zidovudine

To evaluate the effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the treatment of children with symptomatic HIV disease who have had to discontinue zidovudine (AZT) because of intolerance and/or who have experienced progressive disease while on AZT.

The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.

Read the detailed description

The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.

Children who show AZT intolerance and/or progressive disease after 6 months of AZT therapy receive oral ddI at 1 of 2 doses for a minimum of 48 weeks, with a 48-week extension. Patients are seen for clinical and laboratory evaluations at scheduled times during the study. (Per 5/12/92 amendment, new patients will not be enrolled in the pharmacokinetics studies.) Per 10/31/94 amendment: Patients are eligible to receive blinded study drug for an additional 8-16 weeks after the final on-study visit, but no later than 2/15/95.

Conditions
HIV Infections
Being tested
Didanosine
Keywords
Didanosine, 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.

  • DidanosineDrug

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 1995

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
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000963
Sponsor's protocol ID
ACTG 144
Other IDs
11119
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
29 Oct 2021
Results posted
No

Publications

  • Carey VJ, Yong F, Frenkel L, McKinney R. Enhancing the prognostic value of bodily growth histories in HIV-positive pediatric cohorts. Int Conf AIDS. 1996 Jul 7-12;11(2):134 (abstract no WeC3444)

  • Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.

    PubMed 21037891

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 52 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 14 inclusion and 21 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 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 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 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 NCT00000963, which also lists 2 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 29 Oct 2021.

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