NOW Thai HAART Study
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 22, 2006 | ||||
| Last Updated Date | August 22, 2006 | ||||
| Start Date ICMJE | January 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | NOW Thai HAART Study | ||||
| Official Title ICMJE | Neurological Outcomes With in THAI National HAART Program. | ||||
| Brief Summary | After Initiation of HAART in peoples who living with HIV/AIDS in Thailand by the year 2000, rapidly expanded HAART access of national project has been promoted in 2004. Free ARVs (For CD4<200cell/cu.mm. or in symptomatic HIV with CD4<250 cell/cu.mm. )and CD4 monitoring has been available. The first-line regimen is d4T+3TC+NVP in mainly the first time (Naive) patients. CD4 response ), rate of opportunistic infection, and neurological outcomes were measured. Rate of ARV change, adverse events,treatment failure, TB co-infection rate, percent changing to EFV-based regimen or PI-based regimen were recorded. Any Adverse Events including, Sever rash, Severe Hepatitis, Lipid abnormalities, Severe Anemia and Other, common AEs will be analysed. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Cross-Sectional Time Perspective: Retrospective/Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Drug: Highly Active Antiretroviral Treatment (combination of :NRTI, NNRTI,or PI) | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 500 | ||||
| Completion Date | September 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 15 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Thailand | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00367731 | ||||
| Other Study ID Numbers ICMJE | RVH_CER_003 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Rajavithi Hospital | ||||
| Collaborators ICMJE | Rajavithi Biomolecular Research Center | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Rajavithi Hospital | ||||
| Verification Date | August 2006 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||