Drug Levels of Tablet and Liquid Forms of Lamivudine, Nevirapine, and Stavudine in HIV Infected Thai Children
NCT ID: NCT00312091
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
44 participants
INTERVENTIONAL
2006-12-31
2008-09-30
Brief Summary
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Detailed Description
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This study has two stages. Stage 1 will last a minimum of 4 weeks; Stage 2 will last a minimum of 8 weeks. In Stage 1, patients will be randomly assigned to one of two arms. Arm A will receive the fixed-dose tablet twice daily for 2 weeks, then switch to the individual liquid formulations twice daily for 2 weeks. Arm B will receive the individual liquid formulations twice daily for 2 weeks, then switch to the fixed-dose tablet twice daily for 2 weeks. To encourage medication adherence, study staff will make home visits and phone calls to each patient's parent or guardian the first week of each treatment regimen. Medical history, a physical exam, and urine collection will occur on Days 11 and 25. Also on Days 11 and 25, patients will be admitted to the hospital to ensure 100% medication adherence and to provide blood for PK studies.
Stage 1 patients are not eligible for Stage 2. In Stage 2, patients will be stratified by body weight, then randomly assigned to one of two arms. Arm A will receive the fixed-dose tablet twice daily for 4 weeks, then switch to the individual liquid formulations twice daily for 4 weeks. Arm B will receive the individual liquid formulations twice daily for 4 weeks, then switch to the fixed-dose tablet twice daily for 4 weeks. To encourage medication adherence, study staff will make home visits and phone calls to each patient's parent or guardian the first week of each treatment regimen. Medical history, documentation of direct observation of therapy (DOT), a physical exam, and urine collection will occur on Days 25 and 53. Also on Days 25 and 53, patients will be admitted to the hospital to ensure 100% medication adherence and to provide blood for PK studies.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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A, Stage 1
Tablet 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
Lamivudine, nevirapine, and stavudine fixed-dose tablet
7 mg d4T, 30 mg 3TC, 50 mg NVP tablet
Lamivudine
Dosage dependent on weight. More information on this criterion can be found in the protocol.
Nevirapine
Dosage dependent on weight. More information on this criterion can be found in the protocol.
Stavudine
Dosage dependent on weight. More information on this criterion can be found in the protocol.
A, Stage 2
Tablet 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
Lamivudine, nevirapine, and stavudine fixed-dose tablet
7 mg d4T, 30 mg 3TC, 50 mg NVP tablet
Lamivudine
Dosage dependent on weight. More information on this criterion can be found in the protocol.
Nevirapine
Dosage dependent on weight. More information on this criterion can be found in the protocol.
Stavudine
Dosage dependent on weight. More information on this criterion can be found in the protocol.
B, Stage 1
Liquid 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
Lamivudine, nevirapine, and stavudine fixed-dose tablet
7 mg d4T, 30 mg 3TC, 50 mg NVP tablet
Lamivudine
Dosage dependent on weight. More information on this criterion can be found in the protocol.
Nevirapine
Dosage dependent on weight. More information on this criterion can be found in the protocol.
Stavudine
Dosage dependent on weight. More information on this criterion can be found in the protocol.
B, Stage 2
Liquid 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
Lamivudine, nevirapine, and stavudine fixed-dose tablet
7 mg d4T, 30 mg 3TC, 50 mg NVP tablet
Lamivudine
Dosage dependent on weight. More information on this criterion can be found in the protocol.
Nevirapine
Dosage dependent on weight. More information on this criterion can be found in the protocol.
Stavudine
Dosage dependent on weight. More information on this criterion can be found in the protocol.
Interventions
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Lamivudine, nevirapine, and stavudine fixed-dose tablet
7 mg d4T, 30 mg 3TC, 50 mg NVP tablet
Lamivudine
Dosage dependent on weight. More information on this criterion can be found in the protocol.
Nevirapine
Dosage dependent on weight. More information on this criterion can be found in the protocol.
Stavudine
Dosage dependent on weight. More information on this criterion can be found in the protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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)
* Pregnancy
6 Months
13 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Nirun Vanprapar, MD
Role: STUDY_CHAIR
Pediatric Infectious Unit, Department of Pediatrics, Siriraj Hopstial, Mahidol University
Locations
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Queen Sirikit National Institute of Child Health, Pediatric Infectious Unit
Bangkok, Ratchathewi, Thailand
Siriraj Hospital Mahidol University CRS
Bangkok, Ratchathewi, Thailand
Chiang Mai University Pediatrics-Obstetrics CRS
Chiang Mai, , Thailand
Chonburi Hosp. CRS
Chonburri, , Thailand
Countries
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References
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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.
Hoody 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.
King 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.
Vanprapar 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.
Other Identifiers
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10139
Identifier Type: REGISTRY
Identifier Source: secondary_id
PACTG P1056
Identifier Type: -
Identifier Source: secondary_id
IMPAACT P1056
Identifier Type: -
Identifier Source: secondary_id
P1056
Identifier Type: -
Identifier Source: org_study_id