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A Prospective Cohort of Children With HIV Infection
This study is currently recruiting participants.
Verified February 2017 by The HIV Netherlands Australia Thailand Research Collaboration
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborator:
Khon Kaen University
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00476606
First received: May 20, 2007
Last updated: February 22, 2017
Last verified: February 2017
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Purpose
To evaluate clinical and immunological outcome of children treated with HAART.
| Condition | Intervention |
|---|---|
| HIV Infections | Drug: Zidovudine, Stavudine, Didanosine, Lamivudine Drug: Nevirapine, Efavirenz Drug: LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Treatment Outcome of Children With HIV Infection |
Resource links provided by NLM:
Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:
Primary Outcome Measures:
- 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
PBMC
| Estimated Enrollment: | 1000 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | December 2020 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
This is a long term cohort study that was started in 2002. Currently, there are 120 children enrolled in the study and are receiving HIV care according to standard practice set by the Thai Ministry of Public Health. HIV-infected parents also receive care at the same clinic.
Eligibility| Ages Eligible for Study: | up to 20 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV-infected infants, children and adolescents (range age 1 day - 20 years old) who have participated in HIV-NAT trials
Criteria
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.
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476606
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476606
Contacts
| Contact: June Ohata, BS, BA | 662-652-3040 | juneohata4@gmail.com |
Locations
| 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 | |
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Khon Kaen University
Investigators
| Principal Investigator: | Kiat Ruxrungtham, MD, MSc | HIV-NAT, The Thai Red Cross AIDS Research Centre |
More Information
Additional Information:
Publications:
Bunupuradah T., Puthanakit T., Boonrak P., Butterworth O., Mengthaisong T., Intasan J., Ubolyam S., Kosalaraksa P., Engchanil C., Pancharoen C., Lumbiganond P., Phanuphak P., Ananworanich J., HIV-NAT Pediatric Study Team. Efficacy and safety of non nucleoside reverse transcriptase inhibitor (NNRTI) based highly active antiretroviral therapy (HAART) in Thai children with HIV, poster No. TUPEB128. Poster presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Sydney, Australia, July 22-25, 2007
| Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
| ClinicalTrials.gov Identifier: | NCT00476606 History of Changes |
| Other Study ID Numbers: |
HIV-NAT 015 |
| Study First Received: | May 20, 2007 |
| Last Updated: | February 22, 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 |
ClinicalTrials.gov processed this record on July 26, 2017