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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: GPO-Vir Z30 tablet (Drug); Lamivudine (Drug); Nevirapine (Drug); Zidovudine (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Kulkanya Chokephaibulkit, MD, Study Chair, Affiliation: Siriraj Hospital, Mahidol University
Nirum Vanprapar, MD, Study Chair, Affiliation: Siriraj Hospital, Mahidol University
Ram Yogev, MD, Study Chair, Affiliation: CMRC Children's Memorial Hospital

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.

Clinical Details

Official title: A Phase I/II Comparative Pharmacokinetic Study of the Fixed-Dose Combination (FDC) of Zidovudine (ZDV), Lamivudine (3TC), and Nevirapine (NVP) as GPO-Vir Z30 Pediatric Tablets Versus the Individual Liquid Formulations in HIV-Infected Children Greater Than or Equal to Five Months and Less Than 13 Years of Age in Thailand

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Safety and comparative bioavailability measured by concentration difference between the GPO-Vir Z30 and standard liquid regimens

Therapeutic adequacy of NVP measured by treatment-specific concentration distributions

Secondary outcome: Comparisons in PK analyses between GPO-VIR Z30 and standard liquid regimens including pharmacokinetic parameters, adverse drug reactions, and the influence of SNPs on NVP pharmacokinetic parameters

Detailed description: An important factor affecting the therapeutic response to ARVs is adherence. A common reason for poor adherence is high pill burden. A combination fixed dose drug approach appears to be an effective strategy to improve adherence and therapeutic response. In this study, investigators will compare the bioavailability and safety of GPO-VIR Z30, a combination fixed dose drug, with the liquid formulations of ZDV,3TC, and NVP, in children. This study will last approximately 8 weeks. Participants will be randomly assigned to one of two arms. Participants in Arm 1 will receive GPO-VIR Z30 for 2 weeks before receiving liquid formulations of ZDV, 3TC, and NVP for the following 2 weeks. Participants in Arm 2 will receive liquid formulations of ZDV, 3TC, and NVP for 2 weeks before receiving GPO-VIR Z30 for the following 2 weeks. This study will consist of 4 study visits after screening. Visits will occur at study entry and on Days 14, 28, and 56. Medical history and a physical exam will occur at all visits. A pregnancy test will occur for females at all visits. Pharmacokinetic tests, involving hospitalization for the 12 hour procedure, will occur on Days 14 and 28. Safety and adherence monitoring will occur by telephone on Days 7, 11 or 12, 13, 21, 25 or 26, 27, and 35. Home visits for directly observed therapy (DOT) may also occur.

Eligibility

Minimum age: 5 Months. Maximum age: 12 Years. Gender(s): Both.

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

Locations and Contacts

Chiang Mai University Pediatrics-Obstetrics CRS, Chiang Mai 50200, Thailand

Chonburi Hosp. CRS, Chonburi, Thailand

Prapokklao Hosp. CRS, Muang District, Chantaburi 22000, Thailand

Siriraj Hospital Mahidol University CRS, Bangkok, Ratchathewi, Thailand

Additional Information

Click here for more information about lamivudine

Click here for more information about nevirapine

Click here for more information about zidovudine

Related publications:

Kiertiburanakul S, Khongnorasat S, Rattanasiri S, Sungkanuparph S. Efficacy of a generic fixed-dose combination of stavudine, lamivudine and nevirapine (GPO-VIR) in Thai HIV-infected patients. J Med Assoc Thai. 2007 Feb;90(2):237-43.

Manosuthi W, Kiertiburanakul S, Chaovavanich A, Sungkanuparph S. Plasma nevirapine levels and 24-week efficacy of a fixed-dose combination of stavudine, lamivudine and nevirapine (GPO-VIR) among Thai HIV-infected patients. J Med Assoc Thai. 2007 Feb;90(2):244-50.

Starting date: October 2008
Last updated: September 11, 2012

Page last updated: August 23, 2015

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