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

NCT00672412 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-11-09

No results posted yet for this study

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

Interventions

DRUG

GPO-Vir Z30 tablet

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

DRUG

Lamivudine

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

DRUG

Nevirapine

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

DRUG

Zidovudine

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

Sponsors & Collaborators

  • International Maternal Pediatric Adolescent AIDS Clinical Trials Group

    collaborator NETWORK

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Kulkanya Chokephaibulkit, MD · Siriraj Hospital

  • Nirum Vanprapar, MD · Siriraj Hospital

  • Ram Yogev, MD · CMRC Children's Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
5 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00672412 on ClinicalTrials.gov