Status:
COMPLETED
Drug Levels of Tablet and Liquid Forms of Lamivudine, Nevirapine, and Stavudine in HIV Infected Thai Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Conditions:
HIV Infections
Eligibility:
All Genders
6-13 years
Phase:
PHASE1
PHASE2
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 f...
Detailed Description
The Thai Ministry of Public Health strives to provide the HIV infected people of Thailand with affordable antiretrovirals (ARVs). A fixed-dose combination tablet of 3TC, NVP, and d4T is recommended as...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Stages 1 and 2:
- 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
- Inclusion Criteria for Stage 1:
- Between 12 to 30 kg (26.5 to 66.1 lbs)
- Inclusion Criteria for Stage 2:
- Between 6 to 30 kg (13.2 to 66.1 lbs)
- Exclusion Criteria:
- 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)
- Pregnancy
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00312091
Start Date
December 1 2006
End Date
September 1 2008
Last Update
November 2 2021
Active Locations (4)
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1
Queen Sirikit National Institute of Child Health, Pediatric Infectious Unit
Bangkok, Ratchathewi, Thailand, 10400
2
Siriraj Hospital Mahidol University CRS
Bangkok, Ratchathewi, Thailand, 10700
3
Chiang Mai University Pediatrics-Obstetrics CRS
Chiang Mai, Thailand, 50200
4
Chonburi Hosp. CRS
Chonburri, Thailand, 20000 TH