HIV InfectionsPhase 2NCT00000789
A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection
A Phase 2 study testing Stavudine and Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 54 sites in 2 countries.
Trial summary
PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral stavudine (d4T) in symptomatic HIV-infected children. SECONDARY: To compare the clinical, virologic, and immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both drugs. Read more about this study
- Who is it for?
- Ages 3 months to 6 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Stavudine and Zidovudine
- How many people
- 230 participants
- Where
- 54 sitesin 2 countries
- Study dates
- Start not givento Jul 1998
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Concurrent Medication:
- Recommended:
- PCP prophylaxis.
- Allowed:
- Immunoglobulin.
- Erythropoietin, G-CSF, and GM-CSF.
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- Corticosteroids.
- Ethionamide or isoniazid for TB if no alternative is available.
- Pyridoxine (up to 50 mg/day) as vitamin supplement.
- Patients must have:
- Symptomatic HIV infection.
- No more than 6 weeks of prior antiretroviral or immunomodulator therapy (other than steroids and IVIG).
- Consent of parent or guardian.
- NOTE:
- Coenrollment on another ACTG protocol not involving antiretroviral therapy is permitted.
- Prior Medication:
- Allowed:
- Maternal immunomodulator or antiretroviral therapy (including during pregnancy).
- Antiretroviral therapy prior to 2 months.
- Up to 6 weeks of prior antiretroviral therapy or specific immunomodulator therapy (other than corticosteroids and IVIG).
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Current grade 3 or worse neuropathy / lower motor neuropathy.
- Other grade 3 or worse clinical or laboratory toxicities.
- Known intolerance to either AZT or d4T.
- Concurrent Medication:
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- Excluded:
- Chemotherapy for active malignancy.
- Patients with the following prior conditions are excluded:
- History of grade 3 or worse neuropathy/lower motor neuropathy.
- Prior Medication:
- Excluded:
- More than 6 weeks of prior antiretroviral or immunomodulator therapy.
- Antiretroviral or immunomodulator therapy within 7 days prior to study entry. Ongoing drug or alcohol abuse.
Trial locations and contacts
54 sites in 2 countries.
54 sites in 2 countries
United States51 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 Colorado Denver NICHD CRS
Aurora, Colorado, 80218
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, 21201
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
Cooper Univ. Hosp.
Camden, New Jersey, 08103
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
Chapel Hill, North Carolina
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
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
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209
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, 90095
St. Jude/UTHSC CRS
Memphis, Tennessee, 38105
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33161
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, 08903
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/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112
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, 90502
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
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, 00936
About this study
PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral stavudine (d4T) in symptomatic HIV-infected children.
SECONDARY: To compare the clinical, virologic, and immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both drugs.
At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.
Read the detailed description
At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.
Patients are randomized to receive either oral AZT or oral d4T. Treatment continues until the last patient enrolled has received 52 weeks of therapy, or until the study is terminated.
- Conditions
- HIV Infections
- Being tested
- Stavudine, Zidovudine
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Stavudine
- 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.
StavudineDrug
ZidovudineDrug
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 completionJul 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Institute of Allergy and Infectious Diseases (NIAID)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 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 230 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Glaxo Wellcome, Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Kline M, Study chairVan Dyke R, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000789
- Sponsor's protocol ID
- ACTG 240
- Other IDs
- 11217
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Kline MW, Fletcher CV, Federici ME, Harris AT, Evans KD, Rutkiewicz VL, Shearer WT, Dunkle LM. Combination therapy with stavudine and didanosine in children with advanced human immunodeficiency virus infection: pharmacokinetic properties, safety, and immunologic and virologic effects. Pediatrics. 1996 Jun;97(6 Pt 1):886-90.
PubMed 8657531McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173
Kline MW, Van Dyke RB, Lindsey JC, Gwynne M, Culnane M, McKinney RE Jr, Nichols S, Mitchell WG, Yogev R, Hutcheon N. A randomized comparative trial of stavudine (d4T) versus zidovudine (ZDV, AZT) in children with human immunodeficiency virus infection. AIDS Clinical Trials Group 240 Team. Pediatrics. 1998 Feb;101(2):214-20. doi: 10.1542/peds.101.2.214.
PubMed 9445494Perrier 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection
- ClinicalTrials.gov ID
- NCT00000789
- Acronym / sponsor ID
- ACTG 240
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Stavudine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Glaxo Wellcome, Bristol-Myers Squibb
- Study completion
- Jul 1998 (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.
PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral stavudine (d4T) in symptomatic HIV-infected children.
SECONDARY: To compare the clinical, virologic, and immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both drugs.
At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.
Detailed description
At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.
Patients are randomized to receive either oral AZT or oral d4T. Treatment continues until the last patient enrolled has received 52 weeks of therapy, or until the study is terminated.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (20 listed)
- PCP prophylaxis.
- Immunoglobulin.
- Erythropoietin, G-CSF, and GM-CSF.
- Corticosteroids.
- Ethionamide or isoniazid for TB if no alternative is available.
Key exclusion criteria (14 listed)
- Current grade 3 or worse neuropathy / lower motor neuropathy.
- Other grade 3 or worse clinical or laboratory toxicities.
- Known intolerance to either AZT or d4T.
- Chemotherapy for active malignancy.
- History of grade 3 or worse neuropathy/lower motor neuropathy.
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 |
|---|---|---|
| Stavudine | Drug | – |
| Zidovudine | 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 4 Nov 2021.
- Background: PubMed 8657531Kline MW, Fletcher CV, Federici ME, Harris AT, Evans KD, Rutkiewicz VL, Shearer WT, Dunkle LM. Combination therapy with stavudine and didanosine in children with advanced human immunodeficiency virus infection: pharmacokinetic properties, safety, and immunologic and virologic effects. Pediatrics. 1996 Jun;97(6 Pt 1):886-90.
- BackgroundMcKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173
- Background: PubMed 9445494Kline MW, Van Dyke RB, Lindsey JC, Gwynne M, Culnane M, McKinney RE Jr, Nichols S, Mitchell WG, Yogev R, Hutcheon N. A randomized comparative trial of stavudine (d4T) versus zidovudine (ZDV, AZT) in children with human immunodeficiency virus infection. AIDS Clinical Trials Group 240 Team. Pediatrics. 1998 Feb;101(2):214-20. doi: 10.1542/peds.101.2.214.
- Background: PubMed 21037891Perrier 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.
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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.
Kline M study chair
Van Dyke R study chair
54 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stavudine and Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 54 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 20 inclusion and 14 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 4 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 54 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 NCT00000789, which also lists 4 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 4 Nov 2021.