HIV InfectionsNCT00087945
Blood Levels of Abacavir in HIV Infected Adolescents
A study testing Abacavir sulfate and Abacavir sulfate, lamivudine, and zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 20 sites in 2 countries.
Trial summary
The way abacavir (ABC) behaves in the body differs between children and adults, but little is known about ABC in adolescents. It is unclear if adult doses of ABC are appropriate for adolescents. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Abacavir sulfate and Abacavir sulfate, lamivudine, and zidovudine
- How many people
- 30 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Jul 2004to Dec 2004
- Phase
- Interventional
- 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 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV-1 infected
- CD4 count greater than 100 cells/mm3
- Viral load less than 100,000 copies/ml
- Have taken an abacavir-containing regimen for at least 8 weeks prior to study entry
- Weight more than 83 lbs (37.5 kg)
- Ability and willingness to swallow study medications
- Consent of parent or guardian, if applicable
Who cannot join
- Any Grade 3 or greater toxicity within 14 days prior to study entry
- Participation in PACTG P1018
- CDC Category C opportunistic infections or HIV-1 associated cancer requiring drug therapy at the time of study enrollment
- Treatment with immune modulators, including interleukin-2 or intravenous gamma globulin, within 30 days of study entry
- Received therapeutic vaccines or any HIV-1 vaccine given for primary prevention within 30 days of study entry
- Surgical or medical problem affecting gastrointestinal motility or absorption (e.g., ileus, ulcerative colitis) or liver function
Show all 10Show fewer
- History of chronic alcohol use
- Any clinically significant disease other than HIV-1 infection that, in the investigator's opinion, would represent an increased risk for the participant or compromise the outcome of the study
- Chemotherapy for active cancer
- Pregnancy or breastfeeding
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States19 sites
Usc La Nichd Crs
Alhambra, California, 91803
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Augusta, Georgia, 30912
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 02115
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
Chapel Hill, North Carolina, 27599
Chicago Children's CRS
Chicago, Illinois, 60614
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, 48201
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209
Children's Hospital of Los Angeles NICHD CRS
Los Angeles, California, 90027
St. Jude/UTHSC CRS
Memphis, Tennessee, 38105
UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases
New Brunswick, New Jersey, 08901
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112
Columbia IMPAACT CRS
New York, New York, 10032
Rutgers - New Jersey Medical School CRS
Newark, New Jersey, 07103
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, 92103
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, 01199
USF - Tampa NICHD CRS
Tampa, Florida, 33606
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457
Children's National Med. Ctr. Washington DC NICHD CRS
Washington D.C., District of Columbia, 20010
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, 20010
About this study
Official title: Abacavir Pharmacokinetics During Chronic Therapy in HIV-1 Infected Adolescents and Young Adults
The way abacavir (ABC) behaves in the body differs between children and adults, but little is known about ABC in adolescents. It is unclear if adult doses of ABC are appropriate for adolescents. The purpose of this study is to determine the blood levels of ABC in HIV infected adolescents who are on ABC-containing regimens.
Read the detailed description
ABC is approved for the treatment of HIV in adults and children, but it is unclear if currently recommended ABC doses are appropriate for adolescents. Previous data suggest ABC clearance in children is about twice that found in adults, but limited data exist on the pharmacokinetics of ABC in adolescents. This study will evaluate the 8-hour pharmacokinetics of ABC in HIV infected adolescents who are currently on ABC-containing treatment regimens.
There will be two groups in this study. Group 1 participants will be 13 to 17 years old. Group 2 participants will be 18 to 25 years old. All participants will receive a 300 mg dose of ABC as either a single-agent tablet or a combination tablet of ABC, lamivudine, and zidovudine (whichever they are currently taking). Participants will have a medical history assessment and a physical exam at screening and study entry. Participants will also be asked about adherence to their ABC-containing regimen at study entry. During the 8-hour drug level study, blood collection for pharmacokinetic analysis will occur prior to taking ABC, and at 0.5, 1, 2, 3, 4, 6, and 8 hours after taking ABC.
- Conditions
- HIV Infections
- Being tested
- Abacavir sulfate, Abacavir sulfate, lamivudine, and zidovudine
- Keywords
- Treatment Experienced
- 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
Abacavir sulfate, lamivudine, and zidovudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2004 (estimated)
- Study startJul 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- John Rodman, PharmD, Study chair, St. Jude's Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087945
- Sponsor's protocol ID
- PACTG P1052
- Other IDs
- 10194
- Status last verified
- Oct 2013
- First submitted
- 16 Jul 2004
- Last updated
- 8 Oct 2013
- Results posted
- No
Publications
Chittick GE, Gillotin C, McDowell JA, Lou Y, Edwards KD, Prince WT, Stein DS. Abacavir: absolute bioavailability, bioequivalence of three oral formulations, and effect of food. Pharmacotherapy. 1999 Aug;19(8):932-42. doi: 10.1592/phco.19.11.932.31568.
PubMed 10453964Hughes W, McDowell JA, Shenep J, Flynn P, Kline MW, Yogev R, Symonds W, Lou Y, Hetherington S. Safety and single-dose pharmacokinetics of abacavir (1592U89) in human immunodeficiency virus type 1-infected children. Antimicrob Agents Chemother. 1999 Mar;43(3):609-15. doi: 10.1128/AAC.43.3.609.
PubMed 10049275Kline MW, Blanchard S, Fletcher CV, Shenep JL, McKinney RE Jr, Brundage RC, Culnane M, Van Dyke RB, Dankner WM, Kovacs A, McDowell JA, Hetherington S. A phase I study of abacavir (1592U89) alone and in combination with other antiretroviral agents in infants and children with human immunodeficiency virus infection. AIDS Clinical Trials Group 330 Team. Pediatrics. 1999 Apr;103(4):e47. doi: 10.1542/peds.103.4.e47.
PubMed 10103339
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abacavir Pharmacokinetics During Chronic Therapy in HIV-1 Infected Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT00087945
- Acronym / sponsor ID
- PACTG P1052
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 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 start
- Jul 2004
- Study completion
- Dec 2004 (actual)
- First posted
- 19 Jul 2004 (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 way abacavir (ABC) behaves in the body differs between children and adults, but little is known about ABC in adolescents. It is unclear if adult doses of ABC are appropriate for adolescents. The purpose of this study is to determine the blood levels of ABC in HIV infected adolescents who are on ABC-containing regimens.
Detailed description
ABC is approved for the treatment of HIV in adults and children, but it is unclear if currently recommended ABC doses are appropriate for adolescents. Previous data suggest ABC clearance in children is about twice that found in adults, but limited data exist on the pharmacokinetics of ABC in adolescents. This study will evaluate the 8-hour pharmacokinetics of ABC in HIV infected adolescents who are currently on ABC-containing treatment regimens.
There will be two groups in this study. Group 1 participants will be 13 to 17 years old. Group 2 participants will be 18 to 25 years old. All participants will receive a 300 mg dose of ABC as either a single-agent tablet or a combination tablet of ABC, lamivudine, and zidovudine (whichever they are currently taking). Participants will have a medical history assessment and a physical exam at screening and study entry. Participants will also be asked about adherence to their ABC-containing regimen at study entry. During the 8-hour drug level study, blood collection for pharmacokinetic analysis will occur prior to taking ABC, and at 0.5, 1, 2, 3, 4, 6, and 8 hours after taking ABC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- HIV-1 infected
- CD4 count greater than 100 cells/mm3
- Viral load less than 100,000 copies/ml
- Have taken an abacavir-containing regimen for at least 8 weeks prior to study entry
- Weight more than 83 lbs (37.5 kg)
Key exclusion criteria (10 listed)
- Any Grade 3 or greater toxicity within 14 days prior to study entry
- Participation in PACTG P1018
- CDC Category C opportunistic infections or HIV-1 associated cancer requiring drug therapy at the time of study enrollment
- Treatment with immune modulators, including interleukin-2 or intravenous gamma globulin, within 30 days of study entry
- Received therapeutic vaccines or any HIV-1 vaccine given for primary prevention within 30 days of study entry
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 | – |
| Abacavir sulfate, lamivudine, and 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 8 Oct 2013.
- Background: PubMed 10453964Chittick GE, Gillotin C, McDowell JA, Lou Y, Edwards KD, Prince WT, Stein DS. Abacavir: absolute bioavailability, bioequivalence of three oral formulations, and effect of food. Pharmacotherapy. 1999 Aug;19(8):932-42. doi: 10.1592/phco.19.11.932.31568.
- Background: PubMed 10049275Hughes W, McDowell JA, Shenep J, Flynn P, Kline MW, Yogev R, Symonds W, Lou Y, Hetherington S. Safety and single-dose pharmacokinetics of abacavir (1592U89) in human immunodeficiency virus type 1-infected children. Antimicrob Agents Chemother. 1999 Mar;43(3):609-15. doi: 10.1128/AAC.43.3.609.
- Background: PubMed 10103339Kline MW, Blanchard S, Fletcher CV, Shenep JL, McKinney RE Jr, Brundage RC, Culnane M, Van Dyke RB, Dankner WM, Kovacs A, McDowell JA, Hetherington S. A phase I study of abacavir (1592U89) alone and in combination with other antiretroviral agents in infants and children with human immunodeficiency virus infection. AIDS Clinical Trials Group 330 Team. Pediatrics. 1999 Apr;103(4):e47. doi: 10.1542/peds.103.4.e47.
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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.
John Rodman, PharmD study chair
St. Jude's Children's Research Hospital
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abacavir sulfate and Abacavir sulfate, lamivudine, and zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 20 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 7 inclusion and 10 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 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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.
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 NCT00087945, which also lists 3 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 8 Oct 2013.