HIV InfectionsPhase 2NCT00000851
Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children
A Phase 2 study testing Stavudine and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 35 sites in 2 countries.
Trial summary
To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Stavudine and Didanosine
- How many people
- 198 participants
- Where
- 35 sitesin 2 countries
- Study dates
- Start not givento Oct 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 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients must:
- Be on-study, on-treatment in ACTG 240, or receiving AZT monotherapy by prescription for at least 6 months immediately preceding enrollment.
- Have laboratory evidence of HIV-1 infection < 18 months - 2 positive viral tests >= 18 months - 2 positive viral tests or 2 or more positive tests for HIV antibody
- Have parent or legal guardian willing to sign a consent.
- Prior Medication: Required:
- On-study, on-treatment in ACTG 240 (D4T or AZT) or receiving AZT monotherapy by prescription for at least six months immediately preceding this trial.
Who cannot join
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Intractable diarrhea or vomiting.
- Current clinical or laboratory Grade 3 or worse toxicities.
- Concurrent Medication:
- Excluded:
Show all 15Show fewer
- Concurrent use of antiretroviral agents other than those provided by the study, immunomodulators (other than IVIG or corticosteroids), or other investigational drugs except for those in ACTG 254 and ACTG 219.
- Chemotherapy for active malignancy.
- Patients with any of the following prior conditions are excluded:
- Reached an ACTG 240 defined endpoint, or are permanently off ACTG 240 study treatment.
- Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously.
- Subjects who have had chemotherapy for active malignancy.
- Prior Medication:
- Excluded:
- Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously.
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States32 sites
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado
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
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
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
Connecticut Children's Med. Ctr.
Hartford, Connecticut
Texas Children's Hosp. CRS
Houston, Texas, 77030
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33161
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, 08903
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, 11040
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112
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
NJ Med. School CRS
Newark, New Jersey
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, 19134
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York
SUNY Stony Brook NICHD CRS
Stony Brook, New York
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
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
Official title: Trial of Stavudine (d4T) Plus Didanosine (ddI) in Children on Long-Term Stavudine Monotherapy, and Stavudine Versus Stavudine Plus Didanosine in Children on Long-Term Zidovudine Monotherapy: A Rollover Protocol for ACTG 240 Participants and Children Receiving Prescription Zidovudine
To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long term changes from baseline in plasma HIV RNA concentrations. To determine the relationship, if any, between drug exposure and viral burden.
In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.
Read the detailed description
In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.
Eligible subjects receiving d4T will be assigned in an open manner to Arm 1, and subjects who have been receiving zidovudine (AZT) will be assigned in a randomized, double blind manner to Arms 2 and 3. Each subject will receive study drug for 48 weeks as follows: Arm 1 - d4T plus ddI, Arm 2 - d4T alone, Arm 3 - d4T plus ddI.
- Conditions
- HIV Infections
- Being tested
- Stavudine, Didanosine
- Keywords
- Didanosine, Drug Therapy, Combination, Antiviral Agents, Stavudine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StavudineDrug
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 completionOct 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Masking
- Double blind
- Enrolment
- 198 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kline M, Study chairVan Dyke R, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000851
- Sponsor's protocol ID
- ACTG 327
- Other IDs
- 11300
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Kline MW, Van Dyke RB, Lindsey JC, Gwynne M, Culnane M, Diaz C, Yogev R, McKinney RE Jr, Abrams EJ, Mofenson LM. Combination therapy with stavudine (d4T) plus didanosine (ddI) in children with human immunodeficiency virus infection. The Pediatric AIDS Clinical Trials Group 327 Team. Pediatrics. 1999 May;103(5):e62. doi: 10.1542/peds.103.5.e62.
PubMed 10224206Perrier 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
- Trial of Stavudine (d4T) Plus Didanosine (ddI) in Children on Long-Term Stavudine Monotherapy, and Stavudine Versus Stavudine Plus Didanosine in Children on Long-Term Zidovudine Monotherapy: A Rollover Protocol for ACTG 240 Participants and Children Receiving Prescription Zidovudine
- ClinicalTrials.gov ID
- NCT00000851
- Acronym / sponsor ID
- ACTG 327
- Conditions
- HIV Infections
- Keywords
- Didanosine, Drug Therapy, Combination, Antiviral Agents, Stavudine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Oct 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.
To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long term changes from baseline in plasma HIV RNA concentrations. To determine the relationship, if any, between drug exposure and viral burden.
In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.
Detailed description
In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.
Eligible subjects receiving d4T will be assigned in an open manner to Arm 1, and subjects who have been receiving zidovudine (AZT) will be assigned in a randomized, double blind manner to Arms 2 and 3. Each subject will receive study drug for 48 weeks as follows: Arm 1 - d4T plus ddI, Arm 2 - d4T alone, Arm 3 - d4T plus ddI.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Be on-study, on-treatment in ACTG 240, or receiving AZT monotherapy by prescription for at least 6 months immediately preceding enrollment.
- Have laboratory evidence of HIV-1 infection < 18 months - 2 positive viral tests >= 18 months - 2 positive viral tests or 2 or more positive tests for HIV antibody
- Have parent or legal guardian willing to sign a consent.
- On-study, on-treatment in ACTG 240 (D4T or AZT) or receiving AZT monotherapy by prescription for at least six months immediately preceding this trial.
Key exclusion criteria (15 listed)
- Intractable diarrhea or vomiting.
- Current clinical or laboratory Grade 3 or worse toxicities.
- Concurrent use of antiretroviral agents other than those provided by the study, immunomodulators (other than IVIG or corticosteroids), or other investigational drugs except for those in ACTG 254 and ACTG 219.
- Chemotherapy for active malignancy.
- Reached an ACTG 240 defined endpoint, or are permanently off ACTG 240 study treatment.
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 | – |
| 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 4 Nov 2021.
- Background: PubMed 10224206Kline MW, Van Dyke RB, Lindsey JC, Gwynne M, Culnane M, Diaz C, Yogev R, McKinney RE Jr, Abrams EJ, Mofenson LM. Combination therapy with stavudine (d4T) plus didanosine (ddI) in children with human immunodeficiency virus infection. The Pediatric AIDS Clinical Trials Group 327 Team. Pediatrics. 1999 May;103(5):e62. doi: 10.1542/peds.103.5.e62.
- 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
35 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 Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 35 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 6 inclusion and 15 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 35 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 NCT00000851, 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 4 Nov 2021.