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HIV InfectionsPhase 1/2NCT00672412

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

A Phase 1/2 study testing GPO-Vir Z30 tablet, Lamivudine and Nevirapine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 months to 12 years
Conditions the study is for
HIV Infections
What is being tested?
GPO-Vir Z30 tablet, Lamivudine and Nevirapine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
4 sitesThailand
Study dates
Oct 2008to Jan 2010
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 months to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Thailand4 sites

  • Siriraj Hospital Mahidol University CRS

    Bangkok, Ratchathewi

  • Chiang Mai University Pediatrics-Obstetrics CRS

    Chiang Mai, 50200

  • Chonburi Hosp. CRS

    Chon Buri

  • Prapokklao Hosp. CRS

    Muang District, Changwat Chanthaburi, 22000

Other trials in Thailand

About this study

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

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.

Read the 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.

Conditions
HIV Infections
Being tested
GPO-Vir Z30 tablet, Lamivudine, Nevirapine, Zidovudine
Keywords
Treatment Experienced
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GPO-Vir Z30 tabletDrug

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

  • LamivudineDrug

    Also called 3TC, Epivir

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

  • NevirapineDrug

    Also called NVP, Viramune

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

  • ZidovudineDrug

    Also called ZDV, Retrovir

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

Study groups in NCT00672412
Study groupRoleWhat they receive
1ExperimentalParticipants 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.
Receives: Drug: GPO-Vir Z30 tablet; Drug: Lamivudine; Drug: Nevirapine; Drug: Zidovudine
2ExperimentalParticipants 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.
Receives: Drug: GPO-Vir Z30 tablet; Drug: Lamivudine; Drug: Nevirapine; Drug: Zidovudine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Throughout study

  2. Therapeutic adequacy of NVP measured by treatment-specific concentration distributions

    Measured: Throughout study

Secondary outcomes (1)

  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

    Measured: Throughout study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00672412
Sponsor's protocol ID
P1069
Other IDs
10620, IMPAACT P1069
Status last verified
Sep 2012
First submitted
2 May 2008
Last updated
9 Nov 2021
Results posted
No

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.

    PubMed 17375626

  • 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.

    PubMed 17375627

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GPO-Vir Z30 tablet, Lamivudine and Nevirapine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and comparative bioavailability measured by concentration difference between the GPO-Vir Z30 and standard liquid regimens (time frame: Throughout study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00672412, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.

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Clinical Trial NCT00672412 | AzTrials