AIDSNCT00864292
Predictors of Neuro-cognitive Decline and Survival in HIV-infected Subjects
An observational study of AIDS and Dementia, run by SEARCH Research Foundation at 1 site in Thailand.
Trial summary
Patients will be followed every 6 months for a total of 5 visits (Month 0, 6, 12, 18 and 24). The first visit is the screening and entry visit which can occur at any time after the subject finishes SEARCH 001 study but preferably it should occur approximately 6 months after SEARCH 001 study completion. Read more about this study
- Who is it for?
- Any age
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2007to Apr 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- All patients who have completed the SEARCH 001 study are eligible to enroll in this SEARCH 001.1 study provided that they understand and voluntarily sign the informed consent form.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Thailand1 site
South East Asia Research Collaboration with Hawaii
Bangkok, 10330
About this study
Patients will be followed every 6 months for a total of 5 visits (Month 0, 6, 12, 18 and 24). The first visit is the screening and entry visit which can occur at any time after the subject finishes SEARCH 001 study but preferably it should occur approximately 6 months after SEARCH 001 study completion.
At each visit, patients will undergo the following
Read more
- Assessment of function including activity of daily living questionnaire
- History of medical illnesses, medication history
- Neurological examination: All patients will have a neurological evaluation and neuropsychological evaluation to characterize neurocognitive and neurological status. (It is possible that patients within the non-dementia group will meet criteria for dementia after close testing is completed).
- Neuropsychological assessment:
- Thai Depression Inventory.
- HIV viral load and storage of blood for proviral DNA level
Final outcome assessment based on all available data. If possible, it is intended that these diagnoses will be determined through monthly VTC conference calls with UH investigators. This consensus conference will include the Thai investigators, the UH neurologist, the UH neuropsychologist and the UH principal investigators.
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected, no dementia | Patients with HIV-infection but no dementia | |
| HIV-infected, dementia | Patients with HIV-infection and dementia |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startAug 2007
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDSStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEARCH Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Thai Red Cross AIDS Research Centre
- Investigators
- Jintanat Ananworanich, PhD, Principal investigator, SEARCH Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864292
- Sponsor's protocol ID
- SEARCH 001.1
- Status last verified
- Mar 2009
- First submitted
- 17 Mar 2009
- Last updated
- 3 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Neuro-cognitive Decline and Survival in HIV-infected Subjects
- ClinicalTrials.gov ID
- NCT00864292
- Acronym / sponsor ID
- SEARCH 001.1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- SEARCH Research FoundationUniversity, hospital or other
- Collaborators
- Thai Red Cross AIDS Research Centre
- Study start
- Aug 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 Mar 2009 (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.
Patients will be followed every 6 months for a total of 5 visits (Month 0, 6, 12, 18 and 24). The first visit is the screening and entry visit which can occur at any time after the subject finishes SEARCH 001 study but preferably it should occur approximately 6 months after SEARCH 001 study completion.
At each visit, patients will undergo the following
- Assessment of function including activity of daily living questionnaire
- History of medical illnesses, medication history
- Neurological examination: All patients will have a neurological evaluation and neuropsychological evaluation to characterize neurocognitive and neurological status. (It is possible that patients within the non-dementia group will meet criteria for dementia after close testing is completed).
- Neuropsychological assessment:
- Thai Depression Inventory.
- HIV viral load and storage of blood for proviral DNA level
Final outcome assessment based on all available data. If possible, it is intended that these diagnoses will be determined through monthly VTC conference calls with UH investigators. This consensus conference will include the Thai investigators, the UH neurologist, the UH neuropsychologist and the UH principal investigators.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-infected, no dementia | – | –Patients with HIV-infection but no dementia |
| HIV-infected, dementia | – | –Patients with HIV-infection and dementia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- All patients who have completed the SEARCH 001 study are eligible to enroll in this SEARCH 001.1 study provided that they understand and voluntarily sign the informed consent form.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 3 May 2011.
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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.
Jintanat Ananworanich, PhD principal investigator
SEARCH Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AIDS and Dementia, run by SEARCH Research Foundation at 1 site 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 1 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 3 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 May 2011.