Drug Levels of Tablet and Liquid Forms of Lamivudine, Nevirapine, and Stavudine in HIV Infected Thai Children
A Phase I/II Comparative Pharmacokinetic Study of the Fixed-Dose Combination (FDC) of Stavudine (d4T), Lamivudine (3TC), and Nevirapine (NVP) as GPO-VIR Pediatric Chewable Tablets Versus the Individual Liquid Formulations in HIV Infected Children 6 Months and Older to Less Than 13 Years of Age in Thailand
4 other identifiers
interventional
44
1 country
4
Brief Summary
The purpose of this study is to compare the blood levels, absorption, and breakdown of lamivudine (3TC), nevirapine (NVP), and stavudine (d4T) in a fixed-dose tablet to that of the individual liquid formulations of the same anti-HIV drugs in HIV infected Thai children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
Started Dec 2006
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2006
CompletedFirst Posted
Study publicly available on registry
April 7, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedNovember 2, 2021
October 1, 2021
1.8 years
April 5, 2006
October 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Comparative bioavailability
Throughout study
therapeutic adequacy
Throughout study
Secondary Outcomes (1)
Drug absorption from standard pharmacokinetic (PK) analyses
Throughout study
Study Arms (4)
A, Stage 1
EXPERIMENTALTablet containing d4T, 3TC, and NVP taken orally twice daily for the first 4 weeks, then liquid formulations of d4T, 3TC, and NVP taken orally twice daily for the final 4 weeks
A, Stage 2
EXPERIMENTALTablet containing d4T, 3TC, and NVP taken orally twice daily for 4 weeks, then liquid formulations of d4T, 3TC, and NVP taken orally twice daily for 4 weeks
B, Stage 1
EXPERIMENTALLiquid formulations of d4T, 3TC, and NVP taken orally twice daily for 2 weeks, then tablet containing d4T, 3TC, and NVP taken orally twice daily for 2 weeks
B, Stage 2
EXPERIMENTALLiquid formulations of d4T, 3TC, and NVP taken orally twice daily for 4 weeks, then tablet containing d4T, 3TC, and NVP taken orally twice daily for 4 weeks
Interventions
7 mg d4T, 30 mg 3TC, 50 mg NVP tablet
Dosage dependent on weight. More information on this criterion can be found in the protocol.
Dosage dependent on weight. More information on this criterion can be found in the protocol.
Dosage dependent on weight. More information on this criterion can be found in the protocol.
Eligibility Criteria
You may qualify if:
- HIV infected
- On a highly active antiretroviral regimen (HAART) including NVP and 2 nucleoside reverse transcriptase inhibitors and receiving a maintenance of NVP for at least 4 weeks prior to study entry and taking the current recommended oral dose every 12 hours
- Willing to swallow or chew study drugs
- Willing to be hospitalized for the 12 hour PK studies
- Willing to use acceptable forms of contraception
- Parent or guardian willing to provide informed consent
- Between 12 to 30 kg (26.5 to 66.1 lbs)
- Between 6 to 30 kg (13.2 to 66.1 lbs)
You may not qualify if:
- Certain abnormal laboratory values
- Require certain medications
- Grade 2 or greater vomiting within 30 days prior to study entry
- Grade 2 or greater diarrhea within 30 days prior to study entry
- History of immunological failure (CD4 percentage decrease of more than 30% within a 6-month period for children 6 years or younger OR CD4 cell count decrease of more than 30% within a 6-month period for children older than 6 years)
- Current treatment for acute serious bacterial, viral, or opportunistic infection
- History of dose-limiting toxicity requiring treatment discontinuation of any of the study drugs
- Known hypersensitivity to any of the study drugs
- Current surgical or medical problem affecting gastrointestinal motility or absorption (e.g., ileus, ulcerative colitis) or liver function
- Treatment with immune modulators or myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic drugs within 30 days prior to study entry. Patients who have received therapeutic vaccines are not excluded.
- Treatment with experimental drugs within 30 days of study entry
- Acute inflammation of the liver
- Chemotherapy for active cancer
- Any clinically significant diseases other than HIV infection or clinically significant findings that, in the investigator's opinion, may interfere with the study
- Inability to provide a reliable means of contact (e.g., telephone number)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Queen Sirikit National Institute of Child Health, Pediatric Infectious Unit
Bangkok, Ratchathewi, 10400, Thailand
Siriraj Hospital Mahidol University CRS
Bangkok, Ratchathewi, 10700, Thailand
Chiang Mai University Pediatrics-Obstetrics CRS
Chiang Mai, 50200, Thailand
Chonburi Hosp. CRS
Chonburri, 20000 TH, Thailand
Related Publications (4)
Chokephaibulkit K, Plipat N, Cressey TR, Frederix K, Phongsamart W, Capparelli E, Kolladarungkri T, Vanprapar N. Pharmacokinetics of nevirapine in HIV-infected children receiving an adult fixed-dose combination of stavudine, lamivudine and nevirapine. AIDS. 2005 Sep 23;19(14):1495-9. doi: 10.1097/01.aids.0000183625.97170.59.
PMID: 16135903BACKGROUNDHoody DW, Fletcher CV. Pharmacology considerations for antiretroviral therapy in human immunodeficiency virus (HIV)-infected children. Semin Pediatr Infect Dis. 2003 Oct;14(4):286-94. doi: 10.1053/j.spid.2003.09.004.
PMID: 14724793BACKGROUNDKing JR, Kimberlin DW, Aldrovandi GM, Acosta EP. Antiretroviral pharmacokinetics in the paediatric population: a review. Clin Pharmacokinet. 2002;41(14):1115-33. doi: 10.2165/00003088-200241140-00001.
PMID: 12405863BACKGROUNDVanprapar N, Cressey TR, Chokephaibulkit K, Muresan P, Plipat N, Sirisanthana V, Prasitsuebsai W, Hongsiriwan S, Chotpitayasunondh T, Eksaengsri A, Toye M, Smith ME, McIntosh K, Capparelli E, Yogev R; IMPAACT P1056 Team. A chewable pediatric fixed-dose combination tablet of stavudine, lamivudine, and nevirapine: pharmacokinetics and safety compared with the individual liquid formulations in human immunodeficiency virus-infected children in Thailand. Pediatr Infect Dis J. 2010 Oct;29(10):940-4. doi: 10.1097/INF.0b013e3181e2189d.
PMID: 20453709RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nirun Vanprapar, MD
Pediatric Infectious Unit, Department of Pediatrics, Siriraj Hopstial, Mahidol University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2006
First Posted
April 7, 2006
Study Start
December 1, 2006
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
November 2, 2021
Record last verified: 2021-10