HIVNCT00367731
NOW Thai HAART Study
An observational study of HIV and AIDS, run by Department of Medical Services Ministry of Public Health of Thailand at 3 sites in Thailand.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV, AIDS, Neurological Complications
- What is being tested?
- Highly Active Antiretroviral Treatment (combination of :NRTI, NNRTI,or PI)
- How many people
- 500 participants
- Where
- 3 sitesThailand
- Study dates
- Jan 2005to Sep 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV/AIDS patients.
- Age >15 years.
- informed consent
Who cannot join
- Not informed consent
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Rajavithi Hospital
Bangkok, 10400
Lumpang Hospital
Lumpang
Sappasithiprasong Hospital
Ubonratchathani
About this study
Official title: Neurological Outcomes With in THAI National HAART Program.
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.
- Conditions
- HIV, AIDS, Neurological Complications
- Being tested
- Highly Active Antiretroviral Treatment (combination of :NRTI, NNRTI,or PI)
- Keywords
- HIV, AIDS, Neurological complications, HAART
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highly Active Antiretroviral Treatment (combination of :NRTI, NNRTI,or PI)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startJan 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Collaborators
- Rajavithi Biomolecular Research Center
- Investigators
- Subsai Kongsaengdao, M.D., Principal investigator, Department of Medical Services Ministry of Public Health of Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367731
- Sponsor's protocol ID
- RVH_CER_003
- Status last verified
- Aug 2006
- First submitted
- 22 Aug 2006
- Last updated
- 23 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Outcomes With in THAI National HAART Program.
- ClinicalTrials.gov ID
- NCT00367731
- Acronym / sponsor ID
- RVH_CER_003
- Conditions
- HIV, AIDS, Neurological Complications
- Keywords
- HIV, AIDS, Neurological complications, HAART
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Collaborators
- Rajavithi Biomolecular Research Center
- Study start
- Jan 2005
- Study completion
- Sep 2006
- First posted
- 23 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- HIV/AIDS patients.
- Age >15 years.
- informed consent
Key exclusion criteria (1 listed)
- Not informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Highly Active Antiretroviral Treatment (combination of :NRTI, NNRTI,or PI) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subsai Kongsaengdao, M.D. principal investigator
Department of Medical Services Ministry of Public Health of Thailand
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and AIDS, run by Department of Medical Services Ministry of Public Health of Thailand at 3 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2006.