HIV-1-infectionNCT07080138
Research on the Psychological Status of Patients With HIV-1 Infection
An observational study of HIV-1-infection and Anxiety Depression, run by Shanxi Bethune Hospital.
Trial summary
The goal of this observational study is to investigate the neuropsychological states of People Living With HIV(PLWH), the prevalence of social and psychological stress adaptation overload and poor episodic memory in PLWH. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV-1-infection, Anxiety Depression
- What is being tested?
- All kinds of INSTI medications and All kinds of conventional medications
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People Living With HIV
Who may be able to join
- Diagnosis: PLWH can be diagnosed if one of the following three items is met according to the Chinese AIDS Diagnosis and Treatment Guidelines (2021):
- ① HIV antibody screening test positive and HIV supplementation test positive (antibody supplementation test positive or nucleic acid qualitative test positive or nucleic acid quantification>5000 copies/mL);
- ② Has a history of epidemiology or clinical manifestations related to AIDS, tested positive for HIV nucleic acid twice;
- ③ HIV isolation test positive;
- Receive treatment at the hospital participating in the study; Age range: 18-80 years old, male or female not limited;
- Patients who are willing to participate in this clinical study and sign the informed consent form for this study.
Who cannot join
- Individuals who meet any of the following criteria are not eligible to participate in this study:
- Pregnant or lactating women; Men and women who are preparing for natural conception or artificial assisted reproduction;
- Severe aphasia, physical disability, or any other non neuropsychological factors that may hinder the completion of the assessment;
- is currently involved in other research;
- Having a tendency towards violence may endanger the safety of others.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Junyan Zhang, doctor contact
About this study
The goal of this observational study is to investigate the neuropsychological states of People Living With HIV(PLWH), the prevalence of social and psychological stress adaptation overload and poor episodic memory in PLWH. The main questions it aims to observe are: to observe the prevalence of psychopathic states in PLWH with different viral loads and to compare the effects of different treatments on the prevalence of psychopathic states in PLWH. It is helpful to understand the mental health burden faced by PLWH in China, to improve clinicians' awareness of PLWH's mental and psychological state, and formulate targeted psychological support, treatment and nursing programs.
Read the detailed description
Our research is a prospective cohort of PLWH, mainly observing the differences in the prevalence of AO among different treatment strategies; Secondly, observe: ① The changes of neuropsychological symptoms such as newly diagnosed PLWH, AO, and Poor EM compared with the baseline; ② Changes in neuropsychological symptoms such as PLWH, AO, and Poor EM after treatment with different treatment regimens compared to the baseline; ③ For PLWH at different stages, after half a year of treatment, the changes of neuropsychological symptoms such as PLWH, AO, and Poor EM compared with the baseline; ④ Changes in Interpersonal Stress, Work Stress and Daily Stress conditions of PLWH compared with the baseline.
- Conditions
- HIV-1-infection, Anxiety Depression
- Being tested
- All kinds of INSTI medications, All kinds of conventional medications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All kinds of INSTI medicationsDrug
Also called Bictegravir/Emtricitabine/Tenofovir alafenamide Fumarate, Dolutegravir/Emtricitabine/Tenofovir alafenamide Fumarate, Abacavir/Dolutegravir/Lamivudine, Albuvirtide
All kinds of INSTI medications, such as Bictegravir/Emtricitabine/Tenofovir alafenamide Fumarate, Dolutegravir/Emtricitabine/Tenofovir alafenamide Fumarate for PLWH
All kinds of conventional medicationsDrug
Also called Abacavir, Efavirenz, Emtricitabine, Lamivudine
All kinds of conventional medications, such as Abacavir, Efavirenz for PLWH
| Study group | Role | What they receive |
|---|---|---|
| Group INSTI | Treated by INSTI Receives: Drug: All kinds of INSTI medications | |
| Group CONV | Treated by Conventional medicines Receives: Drug: All kinds of conventional medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of AO among different treatment strategies
Observe the differences in the prevalence of AO in PLWH under different treatment strategies
Measured: 2025.8-2026.7
Secondary outcomes (1)
The changes of Poor EM after the treatment of newly diagnosed PLWH
The changes of Poor EM neuropsychological symptoms in newly diagnosed PLWH compared with the baseline under different treatment regimens
Measured: 2025.8-2026.7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Bethune Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xingyu Li, doctor, Principal investigator, Shanxi Bethune Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080138
- Sponsor's protocol ID
- YXLL-2024-162
- Status last verified
- Sep 2024
- First submitted
- 14 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Niu L, Luo D, Liu Y, Silenzio VM, Xiao S. The Mental Health of People Living with HIV in China, 1998-2014: A Systematic Review. PLoS One. 2016 Apr 15;11(4):e0153489. doi: 10.1371/journal.pone.0153489. eCollection 2016.
PubMed 27082749Bing EG, Burnam MA, Longshore D, Fleishman JA, Sherbourne CD, London AS, Turner BJ, Eggan F, Beckman R, Vitiello B, Morton SC, Orlando M, Bozzette SA, Ortiz-Barron L, Shapiro M. Psychiatric disorders and drug use among human immunodeficiency virus-infected adults in the United States. Arch Gen Psychiatry. 2001 Aug;58(8):721-8. doi: 10.1001/archpsyc.58.8.721.
PubMed 11483137Elendu C, Aguocha CM, Okeke CV, Okoro CB, Peterson JC. HIV-related neurocognitive disorders: Diagnosis, Treatment, and Mental Health Implications: A Review. Medicine (Baltimore). 2023 Oct 27;102(43):e35652. doi: 10.1097/MD.0000000000035652.
PubMed 37904369Remien RH, Stirratt MJ, Nguyen N, Robbins RN, Pala AN, Mellins CA. Mental health and HIV/AIDS: the need for an integrated response. AIDS. 2019 Jul 15;33(9):1411-1420. doi: 10.1097/QAD.0000000000002227.
PubMed 30950883Guidi J, Lucente M, Sonino N, Fava GA. Allostatic Load and Its Impact on Health: A Systematic Review. Psychother Psychosom. 2021;90(1):11-27. doi: 10.1159/000510696. Epub 2020 Aug 14.
PubMed 32799204Bobba-Alves N, Juster RP, Picard M. The energetic cost of allostasis and allostatic load. Psychoneuroendocrinology. 2022 Dec;146:105951. doi: 10.1016/j.psyneuen.2022.105951. Epub 2022 Oct 8.
PubMed 36302295Palego L, Giannaccini G, Betti L. Neuroendocrine Response to Psychosocial Stressors, Inflammation Mediators and Brain-periphery Pathways of Adaptation. Cent Nerv Syst Agents Med Chem. 2021;21(1):2-19. doi: 10.2174/1871524920999201214231243.
PubMed 33319677Sonino N, Fava GA, Lucente M, Guidi J. Allostatic Load and Endocrine Disorders. Psychother Psychosom. 2023;92(3):162-169. doi: 10.1159/000530691. Epub 2023 May 30.
PubMed 37253338Eory A, Bekesi D, Eory A, Rozsa S. Physical Exercise as a Resilience Factor to Mitigate COVID-Related Allostatic Overload. Psychother Psychosom. 2021;90(3):200-206. doi: 10.1159/000514331. Epub 2021 Mar 10.
PubMed 33691321Zhao S, Shibata K, Hellyer PJ, Trender W, Manohar S, Hampshire A, Husain M. Rapid vigilance and episodic memory decrements in COVID-19 survivors. Brain Commun. 2022 Jan 19;4(1):fcab295. doi: 10.1093/braincomms/fcab295. eCollection 2022.
PubMed 35128398Ripamonti E, Clerici M. The association of memory disorders and chronic HIV disease in the antiretroviral therapy era: a systematic literature review. HIV Med. 2020 Jan;21(1):9-20. doi: 10.1111/hiv.12793. Epub 2019 Oct 11.
PubMed 31603624Ji J, Zhang Y, Ma Y, Jia L, Cai M, Li Z, Zhang T, Guo C. People who living with HIV/AIDS also have a high prevalence of anxiety disorders: a systematic review and meta-analysis. Front Psychiatry. 2024 Feb 6;15:1259290. doi: 10.3389/fpsyt.2024.1259290. eCollection 2024.
PubMed 38380124Bhatia MS, Munjal S. Prevalence of Depression in People Living with HIV/AIDS Undergoing ART and Factors Associated with it. J Clin Diagn Res. 2014 Oct;8(10):WC01-4. doi: 10.7860/JCDR/2014/7725.4927. Epub 2014 Oct 20.
PubMed 25478433Regan M, Muhihi A, Nagu T, Aboud S, Ulenga N, Kaaya S, Fawzi MCS, Yousafzai AK, Mugusi F, Fawzi WW, Saxena S, Koenen K, Sudfeld CR. Depression and Viral Suppression Among Adults Living with HIV in Tanzania. AIDS Behav. 2021 Oct;25(10):3097-3105. doi: 10.1007/s10461-021-03187-y. Epub 2021 Feb 17.
PubMed 33598866Ruhanya V, Jacobs GB, Naidoo S, Paul RH, Joska JA, Seedat S, Nyandoro G, Engelbrecht S, Glashoff RH. Impact of Plasma IP-10/CXCL10 and RANTES/CCL5 Levels on Neurocognitive Function in HIV Treatment-Naive Patients. AIDS Res Hum Retroviruses. 2021 Sep;37(9):657-665. doi: 10.1089/AID.2020.0203. Epub 2021 Feb 17.
PubMed 33472520
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Psychological Status of Patients With HIV-1 Infection
- ClinicalTrials.gov ID
- NCT07080138
- Acronym / sponsor ID
- YXLL-2024-162
- Conditions
- HIV-1-infection, Anxiety Depression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanxi Bethune HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jul 2025 (actual)
- 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.
The goal of this observational study is to investigate the neuropsychological states of People Living With HIV(PLWH), the prevalence of social and psychological stress adaptation overload and poor episodic memory in PLWH. The main questions it aims to observe are: to observe the prevalence of psychopathic states in PLWH with different viral loads and to compare the effects of different treatments on the prevalence of psychopathic states in PLWH. It is helpful to understand the mental health burden faced by PLWH in China, to improve clinicians' awareness of PLWH's mental and psychological state, and formulate targeted psychological support, treatment and nursing programs.
Detailed description
Our research is a prospective cohort of PLWH, mainly observing the differences in the prevalence of AO among different treatment strategies; Secondly, observe: ① The changes of neuropsychological symptoms such as newly diagnosed PLWH, AO, and Poor EM compared with the baseline; ② Changes in neuropsychological symptoms such as PLWH, AO, and Poor EM after treatment with different treatment regimens compared to the baseline; ③ For PLWH at different stages, after half a year of treatment, the changes of neuropsychological symptoms such as PLWH, AO, and Poor EM compared with the baseline; ④ Changes in Interpersonal Stress, Work Stress and Daily Stress conditions of PLWH compared with the baseline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group INSTI | – | Drug: All kinds of INSTI medicationsTreated by INSTI |
| Group CONV | – | Drug: All kinds of conventional medicationsTreated by Conventional medicines |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People Living With HIV
Key inclusion criteria (6 listed)
- Diagnosis: PLWH can be diagnosed if one of the following three items is met according to the Chinese AIDS Diagnosis and Treatment Guidelines (2021):
- ① HIV antibody screening test positive and HIV supplementation test positive (antibody supplementation test positive or nucleic acid qualitative test positive or nucleic acid quantification>5000 copies/mL);
- ② Has a history of epidemiology or clinical manifestations related to AIDS, tested positive for HIV nucleic acid twice;
- ③ HIV isolation test positive;
- Receive treatment at the hospital participating in the study; Age range: 18-80 years old, male or female not limited;
Key exclusion criteria (5 listed)
- Individuals who meet any of the following criteria are not eligible to participate in this study:
- Pregnant or lactating women; Men and women who are preparing for natural conception or artificial assisted reproduction;
- Severe aphasia, physical disability, or any other non neuropsychological factors that may hinder the completion of the assessment;
- is currently involved in other research;
- Having a tendency towards violence may endanger the safety of others.
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 |
|---|---|---|
| All kinds of INSTI medicationsAlso: Bictegravir/Emtricitabine/Tenofovir alafenamide Fumarate, Dolutegravir/Emtricitabine/Tenofovir alafenamide Fumarate, Abacavir/Dolutegravir/Lamivudine, AlbuvirtideAll kinds of INSTI medications, such as Bictegravir/Emtricitabine/Tenofovir alafenamide Fumarate, Dolutegravir/Emtricitabine/Tenofovir alafenamide Fumarate for PLWH | Drug | Group INSTI |
| All kinds of conventional medicationsAlso: Abacavir, Efavirenz, Emtricitabine, LamivudineAll kinds of conventional medications, such as Abacavir, Efavirenz for PLWH | Drug | Group CONV |
Primary outcome
The prevalence of AO among different treatment strategies
Time frame: 2025.8-2026.7
Observe the differences in the prevalence of AO in PLWH under different treatment strategies
1 secondary outcome
The changes of Poor EM after the treatment of newly diagnosed PLWH
Time frame: 2025.8-2026.7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Background: PubMed 27082749Niu L, Luo D, Liu Y, Silenzio VM, Xiao S. The Mental Health of People Living with HIV in China, 1998-2014: A Systematic Review. PLoS One. 2016 Apr 15;11(4):e0153489. doi: 10.1371/journal.pone.0153489. eCollection 2016.
- Background: PubMed 11483137Bing EG, Burnam MA, Longshore D, Fleishman JA, Sherbourne CD, London AS, Turner BJ, Eggan F, Beckman R, Vitiello B, Morton SC, Orlando M, Bozzette SA, Ortiz-Barron L, Shapiro M. Psychiatric disorders and drug use among human immunodeficiency virus-infected adults in the United States. Arch Gen Psychiatry. 2001 Aug;58(8):721-8. doi: 10.1001/archpsyc.58.8.721.
- Background: PubMed 37904369Elendu C, Aguocha CM, Okeke CV, Okoro CB, Peterson JC. HIV-related neurocognitive disorders: Diagnosis, Treatment, and Mental Health Implications: A Review. Medicine (Baltimore). 2023 Oct 27;102(43):e35652. doi: 10.1097/MD.0000000000035652.
- Background: PubMed 30950883Remien RH, Stirratt MJ, Nguyen N, Robbins RN, Pala AN, Mellins CA. Mental health and HIV/AIDS: the need for an integrated response. AIDS. 2019 Jul 15;33(9):1411-1420. doi: 10.1097/QAD.0000000000002227.
- Background: PubMed 32799204Guidi J, Lucente M, Sonino N, Fava GA. Allostatic Load and Its Impact on Health: A Systematic Review. Psychother Psychosom. 2021;90(1):11-27. doi: 10.1159/000510696. Epub 2020 Aug 14.
- Background: PubMed 36302295Bobba-Alves N, Juster RP, Picard M. The energetic cost of allostasis and allostatic load. Psychoneuroendocrinology. 2022 Dec;146:105951. doi: 10.1016/j.psyneuen.2022.105951. Epub 2022 Oct 8.
- Background: PubMed 33319677Palego L, Giannaccini G, Betti L. Neuroendocrine Response to Psychosocial Stressors, Inflammation Mediators and Brain-periphery Pathways of Adaptation. Cent Nerv Syst Agents Med Chem. 2021;21(1):2-19. doi: 10.2174/1871524920999201214231243.
- Background: PubMed 37253338Sonino N, Fava GA, Lucente M, Guidi J. Allostatic Load and Endocrine Disorders. Psychother Psychosom. 2023;92(3):162-169. doi: 10.1159/000530691. Epub 2023 May 30.
- Background: PubMed 33691321Eory A, Bekesi D, Eory A, Rozsa S. Physical Exercise as a Resilience Factor to Mitigate COVID-Related Allostatic Overload. Psychother Psychosom. 2021;90(3):200-206. doi: 10.1159/000514331. Epub 2021 Mar 10.
- Background: PubMed 35128398Zhao S, Shibata K, Hellyer PJ, Trender W, Manohar S, Hampshire A, Husain M. Rapid vigilance and episodic memory decrements in COVID-19 survivors. Brain Commun. 2022 Jan 19;4(1):fcab295. doi: 10.1093/braincomms/fcab295. eCollection 2022.
- Background: PubMed 31603624Ripamonti E, Clerici M. The association of memory disorders and chronic HIV disease in the antiretroviral therapy era: a systematic literature review. HIV Med. 2020 Jan;21(1):9-20. doi: 10.1111/hiv.12793. Epub 2019 Oct 11.
- Background: PubMed 38380124Ji J, Zhang Y, Ma Y, Jia L, Cai M, Li Z, Zhang T, Guo C. People who living with HIV/AIDS also have a high prevalence of anxiety disorders: a systematic review and meta-analysis. Front Psychiatry. 2024 Feb 6;15:1259290. doi: 10.3389/fpsyt.2024.1259290. eCollection 2024.
- Individual participant dataSharing planned: Undecided
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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.
Junyan Zhang, doctor contact
Xingyu Li, doctor principal investigator
Shanxi Bethune Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection and Anxiety Depression, run by Shanxi Bethune Hospital.
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 6 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: opening soon, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Wang, Doctor (13513635015, wangyaner7711@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of AO among different treatment strategies (time frame: 2025.8-2026.7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07080138, which also lists 17 linked publications.
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 Jul 2025.