Blood Levels of Abacavir in HIV Infected Adolescents
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Abacavir sulfate Drug: Abacavir sulfate, lamivudine, and zidovudine |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Abacavir Pharmacokinetics During Chronic Therapy in HIV-1 Infected Adolescents and Young Adults |
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2004 |
| Study Completion Date: | December 2004 |
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.
Eligibility| Ages Eligible for Study: | 13 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations| United States, California | |
| Los Angeles County Medical Center/USC | |
| Los Angeles, California, United States, 90033 | |
| Childrens Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| UCSD Mother, Child & Adolescent HIV Program | |
| San Diego, California, United States, 92103 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| University of Florida - Health Science Center | |
| Jacksonville, Florida, United States, 32209 | |
| University of South Florida | |
| St Petersburg, Florida, United States, 33701 | |
| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Chicago Childrens Memorial Hospital (Pediatric) | |
| Chicago, Illinois, United States, 60614 | |
| United States, Louisiana | |
| Tulane Univ., Charity Hospital of New Orleans | |
| New Orleans, Louisiana, United States, 70112-2699 | |
| United States, Massachusetts | |
| Childrens Hospital of Boston | |
| Boston, Massachusetts, United States, 02115 | |
| Baystate Medical Center, Springfield | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Michigan | |
| Childrens Hospital of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| Robert Wood Johnson AIDS Program | |
| New Brunswick, New Jersey, United States, 08901-1969 | |
| Univ. of Med. & Dentistry of NJ/Univ. Hospital | |
| Newark, New Jersey, United States, 07101-1709 | |
| United States, New York | |
| Bronx Lebanon Hospital Center | |
| Bronx, New York, United States, 10457 | |
| The Columbia Presbyterian Medical Center | |
| New York, New York, United States | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7220 | |
| United States, Tennessee | |
| St. Jude Childrens Research Hospital, Memphis | |
| Memphis, Tennessee, United States, 38105-2794 | |
| Puerto Rico | |
| San Juan City Hospital | |
| San Juan, Puerto Rico | |
| Study Chair: | John Rodman, PharmD | St. Jude's Children's Research Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00087945 History of Changes |
| Other Study ID Numbers: | PACTG P1052 |
| Study First Received: | July 16, 2004 |
| Last Updated: | October 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Dideoxynucleosides |
Lamivudine Abacavir Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 23, 2013