HIV InfectionsPhase 1NCT00011479
Blood Levels of Abacavir After One Dose in HIV-Infected Children and Adolescents
A Phase 1 study testing Abacavir sulfate in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 24 sites in United States.
Trial summary
The purpose of this study is to measure blood levels of abacavir in children and adolescents over a period of time following a single dose so that a dosage for adolescents can be determined. Little is known about how abacavir is cleared by the body in adolescents. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Abacavir sulfate
- How many people
- 24 participants
- Where
- 24 sitesUnited States
- Study dates
- Start not givento Aug 2002
- 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 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are 9 to 18 years of age.
- Are HIV-positive.
- Have a CD4 cell count above 200 cells/microL.
- Have a viral load (level of HIV in the blood) under 100,000 copies/ml.
- Have not changed their anti-HIV drugs for the 4 weeks before study entry.
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- Are able to swallow study medications.
- Both males and females, agree to use a barrier method of birth control for 3 days after taking the abacavir dose for this study. (This study has been changed. In the earlier version, no birth control was needed.)
- Can be followed at a participating Pediatric AIDS Clinical Trials Unit (PACTU) for the entire study.
- Provide written consent of a parent or guardian, if under 18 years of age.
Who cannot join
- Patients will not be eligible for this study if they:
- Have liver or kidney problems, as shown by screening tests.
- Have medical or surgical problems that affect movement or absorption in the stomach or gut.
- Have an opportunistic (AIDS-related) or serious bacterial infection requiring medicine at the time of enrollment.
- Have any diseases (other than HIV infection) or other findings that, in the investigator's opinion, might make it harmful for the patient to be on the study.
- Have a history of chronic alcohol use.
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- Fall outside of a certain weight range for their age.
- Are pregnant or breast-feeding.
- Are receiving or have received abacavir.
- Are receiving nonnucleoside reverse transcriptase inhibitors, including efavirenz, delavirdine, or nevirapine; hydroxyurea; mycophenylate; rifampin, rifabutin, anticonvulsants, or other drugs that affect the liver; or chemotherapy for active cancer.
- Have received interferons, interleukins, HIV or other vaccines, or experimental therapy within 30 days before entering the study.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Med College of Georgia
Augusta, Georgia, 30912
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
Children's Hosp of Boston
Boston, Massachusetts, 021155724
Med Univ of South Carolina
Charleston, South Carolina, 294253312
Cook County Hosp
Chicago, Illinois, 60612
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
The Med Ctr Inc
Columbus, Georgia, 31901
Columbus Children's Hosp
Columbus, Ohio, 432052696
Children's Med Ctr of Dallas
Dallas, Texas, 75235
Duke Univ Med Ctr
Durham, North Carolina, 277103499
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Children's Hospital of L.A. (Pediatric)
Los Angeles, California, 90054
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
Univ of Miami (Pediatric)
Miami, Florida, 33161
Metropolitan Hosp Ctr
New York, New York, 10029
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
Univ of Rochester Med Ctr
Rochester, New York, 146420001
Univ of California, San Diego
San Diego, California, 92103
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
About this study
Official title: Single Dose Pharmacokinetic Study of Abacavir in HIV-Infected Children and Adolescents
The purpose of this study is to measure blood levels of abacavir in children and adolescents over a period of time following a single dose so that a dosage for adolescents can be determined.
Little is known about how abacavir is cleared by the body in adolescents. It has been shown that young children require a higher abacavir dose based on weight than adults. Older children, or adolescents, may not require as high a dose. This study may provide information as to whether the children's dose or the adult dose is better for HIV-infected adolescents.
Read the detailed description
Pharmacokinetic differences between children and adults have resulted in recommended doses of abacavir based on weight that are higher for children than for adults. There are insufficient data to determine whether the pediatric or adult dose is more appropriate for HIV-infected adolescent patients. This study measures pharmacokinetic data for abacavir in the adolescent population so that an appropriate dosage can be determined.
Patients are evenly enrolled into 2 groups based on Tanner Stage. Group I patients are Tanner Stage 1 or 2 (pre-pubertal). Group II patients are Tanner Stage 3, 4, or 5 (pubertal). Each patient receives a single oral dose of abacavir given as the commercially available oral solution. Pharmacokinetic blood samples are collected before dosing and at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4, 6, and 8 hours post dose for abacavir concentrations.
- Conditions
- HIV Infections
- Being tested
- Abacavir sulfate
- Keywords
- Administration, Oral, Drug Administration Schedule, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Pharmacokinetics, abacavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abacavir sulfateDrug
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 completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 24 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Lawrence D'Angelo, Study chairJohn Rodman, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011479
- Sponsor's protocol ID
- P1018
- Other IDs
- 11653, ACTG P1018, PACTG P1018
- Status last verified
- Oct 2021
- First submitted
- 22 Feb 2001
- Last updated
- 1 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Pharmacokinetic Study of Abacavir in HIV-Infected Children and Adolescents
- ClinicalTrials.gov ID
- NCT00011479
- Acronym / sponsor ID
- P1018
- Conditions
- HIV Infections
- Keywords
- Administration, Oral, Drug Administration Schedule, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Pharmacokinetics, abacavir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study completion
- Aug 2002 (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.
The purpose of this study is to measure blood levels of abacavir in children and adolescents over a period of time following a single dose so that a dosage for adolescents can be determined.
Little is known about how abacavir is cleared by the body in adolescents. It has been shown that young children require a higher abacavir dose based on weight than adults. Older children, or adolescents, may not require as high a dose. This study may provide information as to whether the children's dose or the adult dose is better for HIV-infected adolescents.
Detailed description
Pharmacokinetic differences between children and adults have resulted in recommended doses of abacavir based on weight that are higher for children than for adults. There are insufficient data to determine whether the pediatric or adult dose is more appropriate for HIV-infected adolescent patients. This study measures pharmacokinetic data for abacavir in the adolescent population so that an appropriate dosage can be determined.
Patients are evenly enrolled into 2 groups based on Tanner Stage. Group I patients are Tanner Stage 1 or 2 (pre-pubertal). Group II patients are Tanner Stage 3, 4, or 5 (pubertal). Each patient receives a single oral dose of abacavir given as the commercially available oral solution. Pharmacokinetic blood samples are collected before dosing and at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4, 6, and 8 hours post dose for abacavir concentrations.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Are 9 to 18 years of age.
- Are HIV-positive.
- Have a CD4 cell count above 200 cells/microL.
- Have a viral load (level of HIV in the blood) under 100,000 copies/ml.
- Have not changed their anti-HIV drugs for the 4 weeks before study entry.
Key exclusion criteria (11 listed)
- Have liver or kidney problems, as shown by screening tests.
- Have medical or surgical problems that affect movement or absorption in the stomach or gut.
- Have an opportunistic (AIDS-related) or serious bacterial infection requiring medicine at the time of enrollment.
- Have any diseases (other than HIV infection) or other findings that, in the investigator's opinion, might make it harmful for the patient to be on the study.
- Have a history of chronic alcohol use.
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 |
|---|---|---|
| Abacavir sulfate | 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 2021.
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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.
Lawrence D'Angelo study chair
John Rodman study chair
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abacavir sulfate in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 24 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 10 inclusion and 11 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 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
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 2021.