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

NCT00672412 | Completed Phase 1

• 3 other identifiers: P106910620IMPAACT P1069
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

HIV Infections

Keywords

Treatment Experienced

Outcome Measures

Primary Outcomes (2)

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

  Throughout study

• Therapeutic adequacy of NVP measured by treatment-specific concentration distributions

  Throughout study

Secondary Outcomes (1)

• 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

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

Participants receive GPO-VIR Z30 tablets containing ZDV, 3TC, and NVP for the first 14 days of the study. On Day 15, participants receive liquid ZDV, 3TC, and NVP for the following 14 days of the study.

Drug: GPO-Vir Z30 tablet; Drug: Lamivudine; Drug: Nevirapine; Drug: Zidovudine

2

EXPERIMENTAL

Participants receive liquid ZDV, 3TC, and NVP for the first 14 days of the study. On Day 15, participants receive GPO-VIR Z30 tablets containing ZDV, 3TC, and NVP for the following 14 days of the study.

Drug: GPO-Vir Z30 tablet; Drug: Lamivudine; Drug: Nevirapine; Drug: Zidovudine

Interventions

GPO-Vir Z30 tablet DRUG

Tablet consisting of ZDV 30 mg/3TC 15 mg/NVP 28 mg taken orally twice daily

1; 2

Lamivudine DRUG

Oral suspension containing 10 mg 3TC in each mL. Dosage depends on weight.

Also known as: 3TC, Epivir

1; 2

Nevirapine DRUG

Oral solution containing 10 mg NVP in each mL. Dosage depends on weight.

Also known as: NVP, Viramune

1; 2

Zidovudine DRUG

Oral solution containing 10 mg ZDV in each mL. Dosage depends on weight.

Also known as: ZDV, Retrovir

1; 2

Eligibility Criteria

• Age: 5 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• International Maternal Pediatric Adolescent AIDS Clinical Trials Group: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (4)

Prapokklao Hosp. CRS

Muang District, Changwat Chanthaburi, 22000, Thailand

Location

Siriraj Hospital Mahidol University CRS

Bangkok, Ratchathewi, Thailand

Location

Chiang Mai University Pediatrics-Obstetrics CRS

Chiang Mai, 50200, Thailand

Location

Chonburi Hosp. CRS

Chon Buri, Thailand

Location

Related Publications (2)

• 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.

  PMID: 17375626 BACKGROUND

• 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.

  PMID: 17375627 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Lamivudine; Nevirapine; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Pyridines; Thymidine

Study Officials

• Kulkanya Chokephaibulkit, MD

  Siriraj Hospital

  STUDY CHAIR

• Nirum Vanprapar, MD

  Siriraj Hospital

  STUDY CHAIR

• Ram Yogev, MD

  CMRC Children's Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: October 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: November 9, 2021

Record last verified: 2012-09

Locations

TH (4)