HIV InfectionsPhase 1NCT00000652
A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection
A Phase 1 study testing Zidovudine and Didanosine in people with HIV Infections, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
To assess the safety and tolerance of the combination of zidovudine (AZT) and didanosine (ddI) in children with HIV infection. New approaches to using available agents may provide increased or improved treatment options for AIDS. 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?
- Zidovudine and Didanosine
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Nov 1995
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Corticosteroids for treatment of lymphocytic interstitial pneumonitis.
- Concurrent Treatment:
- Allowed:
- Intravenous hyperalimentation.
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- Patients must have the following:
- P-2 class symptomatic HIV infection as defined by CDC OR who are asymptomatic but whose total CD4 cell count is < 500 cells/mm3.
- Freedom from significant active opportunistic or other infection requiring specific therapy.
- Part B patients:
- Prior treatment with zidovudine (AZT) that was discontinued because of hematologic toxicity.
- Availability of a parent or legal guardian who is sufficiently reliable to give informed consent and follow necessary study procedures including administration of medications and return for follow-up visits.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Critically ill, clinically unstable, or receiving drug therapy for an opportunistic or other infection.
- History of acute or chronic pancreatitis.
- Patients with the following are excluded:
- Critically ill, clinically unstable, or receiving drug therapy for an opportunistic or other infection.
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- History of acute or chronic pancreatitis.
- Prior Medication:
- Excluded:
- Antiretroviral or other antiviral agent within 14 days of entry into study.
- Immunomodulating agents, cytolytic chemotherapeutic agents, corticosteroids within 30 days (except for lymphocytic interstitial pneumonitis).
- Part A patients:
- Zidovudine (AZT) or didanosine (ddI).
- Part B patients:
- Didanosine (ddI).
- Prior Treatment:
- Excluded:
- Radiation therapy within 30 days.
- Intravenous immunoglobulin preparations within 14 days of entry into study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
About this study
To assess the safety and tolerance of the combination of zidovudine (AZT) and didanosine (ddI) in children with HIV infection.
New approaches to using available agents may provide increased or improved treatment options for AIDS. Combination therapy is expected to play a major role in improving survival and quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most extensively evaluated and for which the evidence for antiretroviral effectiveness is strongest.
Read the detailed description
New approaches to using available agents may provide increased or improved treatment options for AIDS. Combination therapy is expected to play a major role in improving survival and quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most extensively evaluated and for which the evidence for antiretroviral effectiveness is strongest.
Patients take AZT and ddI on an empty stomach; ddI is taken 2 minutes after taking antacid. Part A patients receive AZT plus ddI each at ranging doses. Patients in part B may receive a higher dose of ddI than patients in part A. The first patients enrolled are given the lowest dose. Subsequent patients receive increasingly higher doses until a dose limiting toxicity occurs.
- Conditions
- HIV Infections
- Being tested
- Zidovudine, Didanosine
- Keywords
- Didanosine, Drug Evaluation, Drug Therapy, Combination, Zidovudine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZidovudineDrug
DidanosineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionNov 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Intervention model
- Parallel groups
- Enrolment
- 85 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- PA Pizzo, Study chairRN Husson, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000652
- Sponsor's protocol ID
- ACTG 176
- Other IDs
- NCI 91 C-09
- Status last verified
- Oct 2012
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2012
- Results posted
- No
Publications
Mueller BU, Pizzo PA, Farley M, Husson RN, Goldsmith J, Kovacs A, Woods L, Ono J, Church JA, Brouwers P, et al. Pharmacokinetic evaluation of the combination of zidovudine and didanosine in children with human immunodeficiency virus infection. J Pediatr. 1994 Jul;125(1):142-6. doi: 10.1016/s0022-3476(94)70141-5.
PubMed 8021765
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection
- ClinicalTrials.gov ID
- NCT00000652
- Acronym / sponsor ID
- ACTG 176
- Conditions
- HIV Infections
- Keywords
- Didanosine, Drug Evaluation, Drug Therapy, Combination, Zidovudine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study completion
- Nov 1995 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and tolerance of the combination of zidovudine (AZT) and didanosine (ddI) in children with HIV infection.
New approaches to using available agents may provide increased or improved treatment options for AIDS. Combination therapy is expected to play a major role in improving survival and quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most extensively evaluated and for which the evidence for antiretroviral effectiveness is strongest.
Detailed description
New approaches to using available agents may provide increased or improved treatment options for AIDS. Combination therapy is expected to play a major role in improving survival and quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most extensively evaluated and for which the evidence for antiretroviral effectiveness is strongest.
Patients take AZT and ddI on an empty stomach; ddI is taken 2 minutes after taking antacid. Part A patients receive AZT plus ddI each at ranging doses. Patients in part B may receive a higher dose of ddI than patients in part A. The first patients enrolled are given the lowest dose. Subsequent patients receive increasingly higher doses until a dose limiting toxicity occurs.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Corticosteroids for treatment of lymphocytic interstitial pneumonitis.
- Intravenous hyperalimentation.
- P-2 class symptomatic HIV infection as defined by CDC OR who are asymptomatic but whose total CD4 cell count is < 500 cells/mm3.
- Freedom from significant active opportunistic or other infection requiring specific therapy.
- Prior treatment with zidovudine (AZT) that was discontinued because of hematologic toxicity.
Key exclusion criteria (19 listed)
- Critically ill, clinically unstable, or receiving drug therapy for an opportunistic or other infection.
- History of acute or chronic pancreatitis.
- Critically ill, clinically unstable, or receiving drug therapy for an opportunistic or other infection.
- History of acute or chronic pancreatitis.
- Antiretroviral or other antiviral agent within 14 days of entry into study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zidovudine | Drug | – |
| Didanosine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
- Background: PubMed 8021765Mueller BU, Pizzo PA, Farley M, Husson RN, Goldsmith J, Kovacs A, Woods L, Ono J, Church JA, Brouwers P, et al. Pharmacokinetic evaluation of the combination of zidovudine and didanosine in children with human immunodeficiency virus infection. J Pediatr. 1994 Jul;125(1):142-6. doi: 10.1016/s0022-3476(94)70141-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PA Pizzo study chair
RN Husson study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zidovudine and Didanosine in people with HIV Infections, run by National Cancer Institute (NCI) at 1 site 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 12 inclusion and 19 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 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 NCT00000652, 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 1 Nov 2012; AzTrials last refreshed its copy on 29 Oct 2026.