Safety and Pharmacokinetic Study of Fixed Dose Combination of Zidovudine, Lamivudine, and Nevirapine in HIV-Infected Children in Thailand

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

In 2005, there were 50,620 HIV-infected children living in Thailand. Current anti-HIV regimens, comprised of individual pills for each drug, frequently lead to missed doses. To properly control their infection, regimens that are tolerable and effective in children and without pill burden are necessary. The primary purpose of this study is to evaluate the safety and bioavailability of GPO-VIR Z30, a combination fixed dose tablet containing zidovudine (ZDV), lamivudine (3TC), and nevirapine (NVP), in HIV-infected children in Thailand.

• 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; Zidovudine

Criteria

Inclusion Criteria:

• Weigh between 6 and 30 kilograms

• HIV infected

• Receiving HAART regimen of NVP and 2 NRTIs. More information on this criterion can be found in the protocol.

• Agree to use two appropriate forms of contraception. More information on this criterion can be found in the protocol.

• Ability to swallow study drugs

• Willing to be hospitalized for 12-hour intensive PK study

• Agree to use two appropriate forms of contraception. More information on this criterion can be found in the protocol.

• Parent or legal guardian able and willing to provide written informed consent

Exclusion Criteria:

• Certain abnormal laboratory values. More information on this criterion can be found in the protocol.

• Vomiting or diarrhea (greater than Grade 2) within 30 days prior to study entry

• History of immunologic failure. More information on this criterion can be found in the protocol.

• Current treatment for an acute serious bacterial, viral, or opportunistic infection

• History of dose-limiting toxicity requiring treatment discontinuation of any of the study drugs

• Hypersensitivity to study drugs

• Surgical or medical problem affecting gastrointestinal motility or absorption or liver function

• Treatment with experimental drugs within 30 days prior to study entry

• Acute hepatitis

• Chemotherapy for active malignancy

• Any clinically significant diseases or findings during the screening medical history or physical examination that, in the opinion of the investigator, may interfere with the study

• Pregnant