TDF Long Term Study
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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: NCT01815255 |
Recruitment Status :
Completed
First Posted : March 21, 2013
Last Update Posted : July 17, 2020
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Condition or disease | Intervention/treatment |
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HIV-infected Thai Children | Drug: tenofovir (TDF) |
Study Type : | Observational |
Actual Enrollment : | 36 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Efficacy and Safety Evaluation of TDF-based Regimen in Thai HIV-infected Children |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | August 2013 |
Group/Cohort | Intervention/treatment |
---|---|
tenofovir (TDF)
HIV-infected children who are currently on TDF-based regimen or are changing to TDF based on their clinical indication
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Drug: tenofovir (TDF) |
- viral load [ Time Frame: week 48 and 96 ]Number of patients who have viral load less than 50 copies/ml at week 48 and week 96
- renal status [ Time Frame: weeks 24, 48, 72, and 96 ]Number of patients with renal toxicity assessed by GFR and with proximal tubular effect
- adherence [ Time Frame: every 3 months ]Agreement between self reported adherence by visual analogue scale (VAS) pill count and TDM Sensitivity and specificity of self-reported adherence and pill count against gold standards of TDM and undetectable viral load
- resistance [ Time Frame: every 3 months ]Resistant mutations in patients who fail TDF-based regimen and response to new regimen
- adverse events [ Time Frame: weeks 24, 48, 72, and 96 ]Proportion of patients who develop adverse events which are related to TDF and other ARVs
Biospecimen Retention: None Retained

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Ages Eligible for Study: | 8 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- children who are changing to TDF due to adherence problem or treatment failure
- children who are already on TDF due to their clinical indication
Exclusion Criteria:
- child/caretaker refuse to participate in this study
- cannot adhere to the study schedule

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): NCT01815255
Thailand | |
HIV-NAT | |
Bangkok, Thailand, 10330 | |
King Chulalongkorn Hospital, Chulalongkorn University | |
Bangkok, Thailand, 10330 |
Principal Investigator: | Wasana Prasitsuebsai, MD | The HIV Netherlands Australia Thailand Research Collaboration | |
Principal Investigator: | Jurai Wongsawat, MD | Bamrasnadura Institute |
Publications of Results:
Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
ClinicalTrials.gov Identifier: | NCT01815255 |
Other Study ID Numbers: |
HIV-NAT 133 |
First Posted: | March 21, 2013 Key Record Dates |
Last Update Posted: | July 17, 2020 |
Last Verified: | July 2020 |
TDF-based regimen HIV-infected children Thai generic |
safety and efficacy renal status To assess effect of TDF on renal problem in HIV-infected children receiving TDF-based once daily regimen To compare the effectiveness and clinical usefulness of different tools of adherence |
Tenofovir Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents |