HIV InfectionsNCT00476671
Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1
An observational study of HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
Trial summary
To assess the prevalence and risk factors of neurocognitive impairment and psychiatric comorbidities in HIV infected patients who have undetectable viral load, have been on HAART for at least 1 year and have no history of CNS infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- lumbar puncture, MRI, MRS
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2007to Jun 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV infected adults with viral < 50 copies/ml on NNRTI based HAART
Who may be able to join
- Signed informed consent
- Evidence of HIV infection (confirmed positive ELISA and documented history of measurable HIV RNA)
- Age > 18 years old
- Plasma HIV RNA of < 50 copies/ml within 3 months prior to screening
- Have been on only NNRTI-based HAART regimen for the entire duration and for at least1 year.
Who cannot join
- Current AIDS defining illnesses
- Current or history of previous CNS infection.
- Head injury with loss of consciousness greater than 1 hour
- Acute illness within 30 days prior to entry that, in the opinion of investigators, would prevent patients from completing the protocol required procedures.
- Known learning disability including dyslexia
Trial locations and contacts
1 site in 1 country.
Thailand1 site
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, 10330
About this study
Official title: Prevalence and Risk Factors of HIV-associated Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1 Infected Thai Individuals With Undetectable Viral Load in the HAART Era.
To assess the prevalence and risk factors of neurocognitive impairment and psychiatric comorbidities in HIV infected patients who have undetectable viral load, have been on HAART for at least 1 year and have no history of CNS infection.
Read the detailed description
To understand how to prevent and treat HIV-associated neurocognitive impairment and psychiatric comorbidities in HIV-infected Thai individuals who don't have current AIDS related illness or current and prior central nervous system (CNS) infection, and have been well treated with HAART with undetectable HIV RNA.
- Conditions
- HIV Infections
- Being tested
- lumbar puncture, MRI, MRS
- Keywords
- neuropsychiatric, neurocognitive, psychiatric, HIV related dementia, MCMD, HIV-1, Prevalence, risk factors of neurocognitive impairment and psychiatric comorbidities in HIV-1 infected patients with undetectable viral load in the HAART era., Treatment Experienced
- Medical subject headings
- HIV Infections, AIDS Dementia Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar puncture, MRI, MRSProcedure or surgery
lumbar puncture, MRI, MRS are only performed in patients with HIV associated dementia
| Study group | Role | What they receive |
|---|---|---|
| 1 | HIV infected adults with viral load < 50 copies/ml on NNRTI based HAART Receives: Procedure: lumbar puncture, MRI, MRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological testing score
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startMar 2007
- Primary completionApr 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hawaii, SEARCH Research Foundation, Chulalongkorn University, University of Missouri, Department of Psychology, Division of Neuroscience
- Responsible party
- Sponsor
- Investigators
- Jintanat Ananworanich, MD, Ph.D, Principal investigator, The HIV Netherlands Australia Thailand Research Collaboration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476671
- Sponsor's protocol ID
- HIV-NAT 040
- Status last verified
- Jul 2020
- First submitted
- 20 May 2007
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of HIV-associated Neurocognitive Impairment and Psychiatric Comorbidities in HIV-1 Infected Thai Individuals With Undetectable Viral Load in the HAART Era.
- ClinicalTrials.gov ID
- NCT00476671
- Acronym / sponsor ID
- HIV-NAT 040
- Conditions
- HIV Infections
- Keywords
- neuropsychiatric, neurocognitive, psychiatric, HIV related dementia, MCMD, HIV-1, Prevalence, risk factors of neurocognitive impairment and psychiatric comorbidities in HIV-1 infected patients with undetectable viral load in the HAART era., Treatment Experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- University of Hawaii, SEARCH Research Foundation, Chulalongkorn University, University of Missouri, Department of Psychology, Division of Neuroscience
- Study start
- Mar 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 22 May 2007 (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.
To assess the prevalence and risk factors of neurocognitive impairment and psychiatric comorbidities in HIV infected patients who have undetectable viral load, have been on HAART for at least 1 year and have no history of CNS infection.
Detailed description
To understand how to prevent and treat HIV-associated neurocognitive impairment and psychiatric comorbidities in HIV-infected Thai individuals who don't have current AIDS related illness or current and prior central nervous system (CNS) infection, and have been well treated with HAART with undetectable HIV RNA.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: lumbar puncture, MRI, MRSHIV infected adults with viral load < 50 copies/ml on NNRTI based HAART |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected adults with viral < 50 copies/ml on NNRTI based HAART
Key inclusion criteria (5 listed)
- Signed informed consent
- Evidence of HIV infection (confirmed positive ELISA and documented history of measurable HIV RNA)
- Age > 18 years old
- Plasma HIV RNA of < 50 copies/ml within 3 months prior to screening
- Have been on only NNRTI-based HAART regimen for the entire duration and for at least1 year.
Key exclusion criteria (5 listed)
- Current AIDS defining illnesses
- Current or history of previous CNS infection.
- Head injury with loss of consciousness greater than 1 hour
- Acute illness within 30 days prior to entry that, in the opinion of investigators, would prevent patients from completing the protocol required procedures.
- Known learning disability including dyslexia
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 |
|---|---|---|
| lumbar puncture, MRI, MRSlumbar puncture, MRI, MRS are only performed in patients with HIV associated dementia | Procedure or surgery | 1 |
Primary outcome
Neuropsychological testing score
Time frame: 1 day
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 17 Jul 2020.
- The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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, MD, Ph.D principal investigator
The HIV Netherlands Australia Thailand Research Collaboration
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 HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration 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 5 inclusion and 5 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 17 Jul 2020. 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.
What does the primary outcome measure?
Neuropsychological testing score (time frame: 1 day). It is what the study was designed to measure, not a finding.
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 17 Jul 2020.