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NCT00367731 Clinical Trial

NOW Thai HAART Study

HIV Clinical Trial

Official title:
Neurological Outcomes With in THAI National HAART Program.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00367731
Other study ID # RVH_CER_003
Secondary ID
Status Completed
Phase Phase 4
First received August 22, 2006
Last updated August 22, 2006
Start date January 2005
Est. completion date September 2006

Study information
Verified date August 2006
Source Rajavithi Hospital
Contact n/a
Is FDA regulated No
Health authority Thailand: Ministry of Public Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 15 Years and older
Eligibility Inclusion Criteria:

- HIV/AIDS patients.

- Age >15 years.

- informed consent

Exclusion Criteria:

- Not informed consent

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Drug:
• Highly Active Antiretroviral Treatment (combination of :NRTI, NNRTI,or PI)

Locations
Country Name City State
Thailand Rajavithi Hospital Bangkok
Thailand Lumpang Hospital Lumpang
Thailand Sappasithiprasong Hospital Ubonratchathani

Sponsors (2)
Lead Sponsor Collaborator
Rajavithi Hospital Rajavithi Biomolecular Research Center

Country where clinical trial is conducted

Thailand, 

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