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HIV InfectionsPhase 1NCT00000669

A Phase I Safety and Pharmacokinetics Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Infants and Children With AIDS or Symptomatic HIV Infection

A Phase 1 study testing Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 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 determine the safety and maximum tolerated dose (MTD) of 2',3'-dideoxyinosine (ddI), given orally and intravenously, in infants and children with AIDS. The study also measures bloodstream and cerebrospinal fluid (CSF) levels of the administered drug, and provides a preliminary assessment of the effectiveness of ddI… 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?
Didanosine
How many people
25 participants
Where
5 sitesUnited States
Study dates
Start not givento not given
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 Medication:
  • Allowed:
  • Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis if this drug is extended to children.
  • Acute therapy not exceeding 7 days with oral or intravenous acyclovir for herpes simplex infections.
  • Trimethoprim / sulfamethoxazole for Pneumocystis carinii infections during course of study at discretion of investigator after discussion with the sponsor.
  • Symptomatic therapy with analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy as deemed necessary by the principal investigator.
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  • Patients must have:
  • Diagnosis of AIDS as defined by CDC or meeting CDC P2 classification.
  • Patients must be free of opportunistic infection or other serious bacterial, fungal, or parasitic infection at time of entry into study.
  • Life expectancy > 6 months.
  • Parent or guardian (and patient as applicable) able to give informed consent.
  • Available for follow-up for at least 6 months.
  • Allowed: Hemophilia.

Who cannot join

  • Co-existing Condition:
  • Children with the following are excluded:
  • Chronic hematologic disorders unrelated to coagulation defects, hemoglobinopathies, or ITP.
  • Intractable diarrhea.
  • No venous access.
  • History of seizures within previous 2 years or currently requiring anticonvulsants for control.
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  • Currently active heart disease as evidenced by a cardiac arrhythmia or other significant abnormality on routine electrocardiography (ECG) or shortening fraction of < 10 percent on echocardiogram.
  • Renal disease.
  • Any other clinical condition that in the opinion of the investigator makes the patient unsuitable for study.
  • Concurrent Medication:
  • Excluded:
  • Antiretroviral drugs.
  • Zidovudine (AZT).
  • AL 721.
  • Interferon.
  • Corticosteroids.
  • Immunomodulating drugs.
  • Other systemic investigation agent.
  • Ribavirin.
  • Rifampin, barbiturates, or any other potent inducer or inhibitor of drug-metabolizing enzymes.
  • Cytotoxic anticancer therapy.
  • H-2 blockers.
  • Intravenous ketoconazole.
  • Immunoglobulin preparations.
  • Children with the following are excluded:
  • Chronic hematologic disorders unrelated to coagulation defects, hemoglobinopathies, or ITP.
  • Intractable diarrhea.
  • No venous access.
  • History of seizures within previous 2 years or currently requiring anticonvulsants for control.
  • Currently active heart disease as evidenced by a cardiac arrhythmia or other significant abnormality on routine electrocardiography (ECG) or shortening fraction of < 10 percent on echocardiogram.
  • Renal disease.
  • Any other clinical condition that in the opinion of the investigator makes the patient unsuitable for study.
  • Renal disease.
  • Prior Medication:
  • Excluded:
  • Any prior therapy which in the opinion of the investigator would make the patient unsuitable for study.
  • Excluded within 2 weeks of study entry:
  • Trimethoprim / sulfamethoxazole.
  • Excluded within 1 month of study entry:
  • Study drug or other antiretroviral drug or systemic investigational agent.
  • Any agent known as a potent inducer or inhibitor of drug metabolizing enzymes.
  • H-2 blockers.
  • Ketoconazole.
  • Immunoglobulin preparations.
  • Excluded within 3 months of study entry:
  • Ribavirin.
  • Excluded:
  • Zidovudine (AZT) for > 6 months.
  • Cytotoxic anticancer therapy.
  • Prior Treatment:
  • Excluded within 4 weeks of study entry:
  • Blood transfusion.
  • Lymphocyte transfusions for immune reconstitution.
  • Bone marrow transplant.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Univ of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Univ TX Health Science Ctr

    Houston, Texas, 77030

  • The Regional Medical Ctr, Memphis

    Memphis, Tennessee, 38105

  • Univ of Miami School of Medicine

    Miami, Florida, 331361013

Other trials in United States

About this study

To determine the safety and maximum tolerated dose (MTD) of 2',3'-dideoxyinosine (ddI), given orally and intravenously, in infants and children with AIDS. The study also measures bloodstream and cerebrospinal fluid (CSF) levels of the administered drug, and provides a preliminary assessment of the effectiveness of ddI on HIV replication.

AMENDED: Based on safety established in the first dosing phase of 52 weeks and long term dosing data in adults, the dosing period will be extended to 104 weeks. Original design: Information presently available indicates that ddI has high antiviral activity with less apparent toxicity than zidovudine (AZT) (the drug presently used to treat AIDS).

Read the detailed description

AMENDED: Based on safety established in the first dosing phase of 52 weeks and long term dosing data in adults, the dosing period will be extended to 104 weeks. Original design: Information presently available indicates that ddI has high antiviral activity with less apparent toxicity than zidovudine (AZT) (the drug presently used to treat AIDS).

AMENDED: Dosing will proceed for 104 weeks at each dose level. Original design: Five patients are treated at the initial dose level. Because ddI is not stable in the acid environment of the stomach, oral doses of ddI follow administration of an antacid. An alternative method of dosing is to mix the reconstituted ddI with an appropriate volume of Maalox TC or Mylanta II. In order to determine the MTD, successive groups of 5 patients enter the study at a higher dose level after 3 patients have experienced 3 weeks of dosing and significant toxicities have not developed. Patients are assigned to treatment groups in the order in which they are enrolled. Dosing proceeds for 16 weeks at each dose level. However, consideration is given to escalating patients entered at the lowest dose to the next dose level after 10 weeks of dosing. The dose escalation continues until toxicities requiring dose modifications are found in 2 of 5 in any group.

Conditions
HIV Infections
Being tested
Didanosine
Keywords
Didanosine, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
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)

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
25 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000669
Sponsor's protocol ID
ACTG 091
Other IDs
070V1, AI454-003
Status last verified
Oct 1996
First submitted
2 Nov 1999
Last updated
26 Aug 2008
Results posted
No

Publications

  • Butler KM, Husson RN, Balis FM, Brouwers P, Eddy J, el-Amin D, Gress J, Hawkins M, Jarosinski P, Moss H, et al. Dideoxyinosine in children with symptomatic human immunodeficiency virus infection. N Engl J Med. 1991 Jan 17;324(3):137-44. doi: 10.1056/NEJM199101173240301.

    PubMed 1670591

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 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 13 inclusion and 54 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 26 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 NCT00000669, which also lists 1 linked publication.

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 26 Aug 2008.

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