A Prospective Cohort of Children With HIV Infection
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ClinicalTrials.gov Identifier: NCT00476606 |
Recruitment Status
:
Recruiting
First Posted
: May 22, 2007
Last Update Posted
: February 24, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
HIV Infections | Drug: Zidovudine, Stavudine, Didanosine, Lamivudine Drug: Nevirapine, Efavirenz Drug: LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir |
Study Type : | Observational |
Estimated Enrollment : | 1000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Treatment Outcome of Children With HIV Infection |
Study Start Date : | March 2003 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |

Group/Cohort | Intervention/treatment |
---|---|
Long-term pediatric cohort
Long-term follow-up cohort since 2003
|
Drug: Zidovudine, Stavudine, Didanosine, Lamivudine
Refer to the Thai guideline for HIV management 2007
Drug: Nevirapine, Efavirenz
Refer to the Thai guideline for HIV management 2007
Drug: LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir
Refer to the Thai guideline for HIV management 2007
|
- 1. To collect clinical and immunologic data of children treated with HAART 2. To collect clinical outcome data on children with HIV infection 3. To provide the best possible care to children with HIV infection [ Time Frame: every 3 months ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | up to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Children who are part of the ATC program at Chulalongkorn hospital and at HIV-NAT, The Thai Red Cross AIDS research center
- Children who fulfil criteria to start HAART according to the ATC program
- Children who are switched to second regimen or salvage therapy
- Children who are on any antiretroviral regimens, including post trial children from other HIV-NAT study (both at HIV-NAT and Khon Kaen University sites)
- Children with HIV infection who are not on antiretroviral therapy
- Caretakers understand the purpose of data and plasma samples collection, and have signed the consent form
Exclusion Criteria:
- Patients and caretakers may choose to stop HAART at anytime during the study. If they agree, we would continue to follow them in this study.

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): NCT00476606
Contact: June Ohata, BS, BA | 662-652-3040 | juneohata4@gmail.com |
Thailand | |
HIV-NAT | Recruiting |
Bangkok, Thailand, 10330 | |
Contact: June Ohata, BS, BA 662-652-3040 juneohata4@gmail.com | |
Sub-Investigator: Thanyawee Puthanakit, MD | |
Pediatric infectious diseases section, Chulalongkorn University | Recruiting |
Bangkok, Thailand, 10330 | |
Contact: Chitsanu Pancharoen, MD | |
Khon Kaen University | Recruiting |
Khon Kaen, Thailand, 40002 | |
Contact: Pope Kosalaraksa, MD | |
Sub-Investigator: Chulapan Engchanil, MD | |
Sub-Investigator: Pagakrong Lumbiganon, MD |
Principal Investigator: | Kiat Ruxrungtham, MD, MSc | HIV-NAT, The Thai Red Cross AIDS Research Centre |
Additional Information:
Publications of Results:
Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
ClinicalTrials.gov Identifier: | NCT00476606 History of Changes |
Other Study ID Numbers: |
HIV-NAT 015 |
First Posted: | May 22, 2007 Key Record Dates |
Last Update Posted: | February 24, 2017 |
Last Verified: | February 2017 |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
HIV children HAART ARV Second line HAART |
Viral Load Combination drug Treatment Experienced Treatment Naive |
Additional relevant MeSH terms:
Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir Nelfinavir |
Indinavir Saquinavir Lamivudine Zidovudine Nevirapine Stavudine Didanosine Efavirenz HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents |