Safety and Pharmacokinetic Study of Fixed Dose Combination of Zidovudine, Lamivudine, and Nevirapine in HIV-Infected Children in Thailand
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00672412 |
Recruitment Status
:
Completed
First Posted
: May 6, 2008
Last Update Posted
: September 13, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: GPO-Vir Z30 tablet Drug: Lamivudine Drug: Nevirapine Drug: Zidovudine | Phase 1 Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | October 2008 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | January 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
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
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.
Other Names:
Drug: Nevirapine
Oral solution containing 10 mg NVP in each mL. Dosage depends on weight.
Other Names:
Drug: Zidovudine
Oral solution containing 10 mg ZDV in each mL. Dosage depends on weight.
Other Names:
|
Experimental: 2
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
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.
Other Names:
Drug: Nevirapine
Oral solution containing 10 mg NVP in each mL. Dosage depends on weight.
Other Names:
Drug: Zidovudine
Oral solution containing 10 mg ZDV in each mL. Dosage depends on weight.
Other Names:
|
- Safety and comparative bioavailability measured by concentration difference between the GPO-Vir Z30 and standard liquid regimens [ Time Frame: Throughout study ]
- Therapeutic adequacy of NVP measured by treatment-specific concentration distributions [ Time Frame: Throughout study ]
- 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 [ Time Frame: Throughout study ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 5 Months to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672412
Thailand | |
Prapokklao Hosp. CRS | |
Muang District, Chantaburi, Thailand, 22000 | |
Siriraj Hospital Mahidol University CRS | |
Bangkok, Ratchathewi, Thailand | |
Chiang Mai University Pediatrics-Obstetrics CRS | |
Chiang Mai, Thailand, 50200 | |
Chonburi Hosp. CRS | |
Chonburi, Thailand |
Study Chair: | Kulkanya Chokephaibulkit, MD | Siriraj Hospital | |
Study Chair: | Nirum Vanprapar, MD | Siriraj Hospital | |
Study Chair: | Ram Yogev, MD | CMRC Children's Memorial Hospital |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00672412 History of Changes |
Other Study ID Numbers: |
P1069 10620 ( Registry Identifier: DAIDS ES ) IMPAACT P1069 |
First Posted: | May 6, 2008 Key Record Dates |
Last Update Posted: | September 13, 2012 |
Last Verified: | September 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine Zidovudine Nevirapine |
Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Antimetabolites Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |