Drug Levels of Tablet and Liquid Forms of Lamivudine, Nevirapine, and Stavudine in HIV Infected Thai Children
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Pharmacokinetics, Treatment Experienced
Eligibility Criteria
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
Sites / Locations
- Queen Sirikit National Institute of Child Health, Pediatric Infectious Unit
- Siriraj Hospital Mahidol University CRS
- Chiang Mai University Pediatrics-Obstetrics CRS
- Chonburi Hosp. CRS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
A, Stage 1
A, Stage 2
B, Stage 1
B, Stage 2
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
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
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
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