NCT00367731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2006

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

August 23, 2006

Status Verified

August 1, 2006

First QC Date

August 22, 2006

Last Update Submit

August 22, 2006

Conditions

HIVAIDSNeurological Complications

Keywords

HIVAIDSNeurological complicationsHAART

Interventions

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

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • HIV/AIDS patients.
  • Age \>15 years.
  • informed consent

You may not qualify if:

  • Not informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Lumpang Hospital

Lumpang, Thailand

Location

Sappasithiprasong Hospital

Ubonratchathani, Thailand

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Subsai Kongsaengdao, M.D.

    Department of Medical Services Ministry of Public Health of Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 22, 2006

First Posted

August 23, 2006

Study Start

January 1, 2005

Study Completion

September 1, 2006

Last Updated

August 23, 2006

Record last verified: 2006-08

Locations

TH(3)