Drug Levels of Tablet and Liquid Forms of Lamivudine, Nevirapine, and Stavudine in HIV Infected Thai Children

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Treatments: Lamivudine; Nevirapine; Stavudine

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