HIV InfectionsPhase 1NCT00000814
A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease
A Phase 1 study testing Nevirapine, Zidovudine and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 68 sites in 2 countries.
Trial summary
To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection. The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Read more about this study
- Who is it for?
- Ages 6 months to 20 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nevirapine, Zidovudine and Didanosine
- How many people
- 390 participants
- Where
- 68 sitesin 2 countries
- Study dates
- Start not givento Nov 1998
- 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 6 months to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Erythropoietin.
- Concurrent Treatment:
- Allowed:
- Transfusion.
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- Patients must have:
- Progressive HIV disease.
- At least 24 weeks prior cumulative nucleoside analog antiretroviral monotherapy or combination therapy.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Active malignancy requiring chemotherapy.
- Currently receiving therapy in an ACTG primary therapy or salvage protocol who have NOT met an endpoint on that study.
- Known intolerance (other than hematologic) or toxicity to ddI, AZT, or NVP at the doses used in this study.
- Concurrent Medication:
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- Excluded (unless exemption made by study chair):
- Oral anticoagulants (warfarin, dicumarol).
- Oral contraceptives.
- Digitalis glycosides.
- Phenytoin.
- Theophylline.
- Patients with the following prior conditions are excluded:
- History of clinical pancreatitis.
- History of grade 2 or worse peripheral neuropathy.
- Prior Treatment:
- Excluded:
- Acute treatment for a serious bacterial, viral, or opportunistic infection within 14 days prior to study entry.
Trial locations and contacts
68 sites in 2 countries.
68 sites in 2 countries
United States65 sites
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294
Children's Hosp of Boston
Boston, Massachusetts, 021155724
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, 11203
SUNY - Brooklyn
Brooklyn, New York, 11203
Med Univ of South Carolina
Charleston, South Carolina, 294253312
Cook County Hosp
Chicago, Illinois, 60612
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
Columbus Children's Hosp
Columbus, Ohio, 432052696
Children's Med Ctr of Dallas
Dallas, Texas, 75235
West Central Ohio Hemophilia Ctr / Children's Med Ctr
Dayton, Ohio, 454041815
Children's Hosp of Denver
Denver, Colorado, 802181088
Children's Hosp of Michigan
Detroit, Michigan, 48201
Duke Univ Med Ctr
Durham, North Carolina, 277103499
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, 27710
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
North Shore Univ Hosp
Great Neck, New York, 11021
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
Univ of Pittsburgh Med School / Hershey Med Ctr
Hershey, Pennsylvania, 170330850
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
Univ of Miami (Pediatric)
Miami, Florida, 33161
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
Yale Univ Med School
New Haven, Connecticut, 06504
Schneider Children's Hosp
New Hyde Park, New York, 11040
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
Beth Israel Med Ctr / Pediatrics
New York, New York, 10003
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Cornell Univ Med College
New York, New York, 10021
Metropolitan Hosp Ctr
New York, New York, 10029
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
New York, New York, 10029
Mount Sinai Med Ctr / Pediatrics
New York, New York, 10029
Columbia Presbyterian Med Ctr
New York, New York, 10032
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, 10032
Harlem Hosp Ctr
New York, New York, 10037
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507
Children's Hosp of Oakland
Oakland, California, 946091809
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
Rhode Island Hosp / Brown Univ
Providence, Rhode Island, 02903
Univ of Rochester Medical Center
Rochester, New York, 14642
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457
Bronx Municipal Hosp Ctr / Bronx Lebanon Hosp Ctr
The Bronx, New York, 10461
Westchester Hosp
Valhalla, New York, 10595
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 200072197
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
Puerto Rico3 sites
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, 00956
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067
San Juan City Hosp
San Juan, 009367344
About this study
To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection.
The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.
Read the detailed description
The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.
In Stage 1 of the study, a minimum of 22 patients are randomized to each of three treatment arms: didanosine (ddI) plus AZT plus nevirapine (NVP); ddI plus AZT; and ddI plus NVP. After 12 weeks of treatment, the study proceeds to Stage 2 provided at least 40 percent of patients in Stage 1 show a reduction of at least 40 percent from baseline ICD p24 antigen of greater than or equal to 70 pg/ml AND fewer than two patients experience grade 4 rash. Patients in Stage 1 continue treatment for an additional 36 weeks. In Stage 2, additional patients are randomized to each original treatment regimen until a maximum of 130 patients per arm have been entered. Stage 2 patients receive treatment for at least 48 weeks.
AS PER AMENDMENT 02/12/97: As of 2/28/97, patients receiving study drugs will be offered blinded study drugs for an additional 16 weeks (until 6/30/97). Patients will be unblinded on or about 5/23/97.
- Conditions
- HIV Infections
- Being tested
- Nevirapine, Zidovudine, Didanosine
- Keywords
- Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Nevirapine
- 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.
NevirapineDrug
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 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 1
- Primary purpose
- Treatment
- Enrolment
- 390 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Burchett S, Study chairLuzuriaga K, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000814
- Sponsor's protocol ID
- ACTG 245
- Other IDs
- 11222
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 28 Oct 2021
- Results posted
- No
Publications
McKinney 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
Burchett SK, Carey V, Yong F, Sullivan J, Sulzbacher S, Civitello L, Culnane M, Mofenson L, Siminski S, Robinson P, Luzuriaga K. Virologic activity of didanosine (ddI), zidovudine (ZDV) and nevirapine (NVP) combinations in pediatric subjects with advanced HIV disease (ACTG 245). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:130 (abstract no 271)
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 21037891Burchett S, Sullivan J, Luzuriaga K, Carey V, Yong F, Culnane M, Mofenson L, Robinson P. Combinations of didanosine (DDI), zidovudine (ZDV) and nevirapine (NVP) can reduce CSF HIV-1 viral load in pediatric patients with advanced HIV disease. Int Conf AIDS. 1998;12:62 (abstract no 12253)
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease
- ClinicalTrials.gov ID
- NCT00000814
- Acronym / sponsor ID
- ACTG 245
- Conditions
- HIV Infections
- Keywords
- Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Nevirapine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Nov 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 compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection.
The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.
Detailed description
The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.
In Stage 1 of the study, a minimum of 22 patients are randomized to each of three treatment arms: didanosine (ddI) plus AZT plus nevirapine (NVP); ddI plus AZT; and ddI plus NVP. After 12 weeks of treatment, the study proceeds to Stage 2 provided at least 40 percent of patients in Stage 1 show a reduction of at least 40 percent from baseline ICD p24 antigen of greater than or equal to 70 pg/ml AND fewer than two patients experience grade 4 rash. Patients in Stage 1 continue treatment for an additional 36 weeks. In Stage 2, additional patients are randomized to each original treatment regimen until a maximum of 130 patients per arm have been entered. Stage 2 patients receive treatment for at least 48 weeks.
AS PER AMENDMENT 02/12/97: As of 2/28/97, patients receiving study drugs will be offered blinded study drugs for an additional 16 weeks (until 6/30/97). Patients will be unblinded on or about 5/23/97.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 6 months to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Erythropoietin.
- Transfusion.
- Progressive HIV disease.
- At least 24 weeks prior cumulative nucleoside analog antiretroviral monotherapy or combination therapy.
Key exclusion criteria (18 listed)
- Active malignancy requiring chemotherapy.
- Currently receiving therapy in an ACTG primary therapy or salvage protocol who have NOT met an endpoint on that study.
- Known intolerance (other than hematologic) or toxicity to ddI, AZT, or NVP at the doses used in this study.
- Oral anticoagulants (warfarin, dicumarol).
- Oral contraceptives.
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 |
|---|---|---|
| Nevirapine | Drug | – |
| 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 28 Oct 2021.
- 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
- BackgroundBurchett SK, Carey V, Yong F, Sullivan J, Sulzbacher S, Civitello L, Culnane M, Mofenson L, Siminski S, Robinson P, Luzuriaga K. Virologic activity of didanosine (ddI), zidovudine (ZDV) and nevirapine (NVP) combinations in pediatric subjects with advanced HIV disease (ACTG 245). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:130 (abstract no 271)
- 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.
- BackgroundBurchett S, Sullivan J, Luzuriaga K, Carey V, Yong F, Culnane M, Mofenson L, Robinson P. Combinations of didanosine (DDI), zidovudine (ZDV) and nevirapine (NVP) can reduce CSF HIV-1 viral load in pediatric patients with advanced HIV disease. Int Conf AIDS. 1998;12:62 (abstract no 12253)
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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.
Burchett S study chair
Luzuriaga K study chair
68 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nevirapine, Zidovudine and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 68 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 9 inclusion and 18 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 28 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 68 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 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 NCT00000814, 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 28 Oct 2021.