Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Total Enrollment
10000 participants
Study Classification
OBSERVATIONAL
Study Start Date
2002-11-30
Study Completion Date
2030-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
With HIV/AIDS increasingly considered a chronic disease, 24-, or 48-week data from antiretroviral studies are no longer sufficient. Only with long-term follow-up and outcome data will shed some much-needed light on the answers of questions that have stumped us for several years. Data from a large observational cohort of patients treated with combination antiretroviral therapy will provide further insights into the long-term safety and durability of various antiretroviral therapeutic approached, the efficacy of HIV viral load and CD4 cell counts as predictors of disease progression and mortality, and the importance of adherence.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl
NCT00532168
HIV Infections
COMPLETED
PHASE4
A Study to Explore Reconstitution of Immunity in Patients With Advanced HIV-1-infection
NCT01296373
HIV Immune Restoration
COMPLETED
A Study to Evaluate Virologic Response in Participants Newly Diagnosed With HIV-1
NCT04147325
HIV
COMPLETED
Early ART to Limit Infection and Establishment of Reservoir
NCT02859558
HIV-1 Infection
COMPLETED
PHASE2
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
NCT01475838
Acquired Immunodeficiency Syndrome
HIV Infections
COMPLETED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary Objective:
To collect and evaluate long-term clinical outcomes of HIV infected participants previously enrolled in HIV-NAT trials.
Secondary Objective:
To Assess:
1. Long-term consequences of initiation of antiretroviral as predicted by baseline CD4 cell count and/or baseline plasma HIV RNA level
2. Incidence of lipodystrophy and other metabolic complications in three different groups of patients initially treated with NRTI-based regimens, NNRTI-based regimens, or PI-based regimens
3. Class-specific incidence of lipodystrophy and metabolic complications such as d4T versus AZT, nevirapine versus efavirenz and individual PIs (IDV, SQV, Kaletra, and atazanavir)
4. Resistance profiles in patients on different antiretroviral regimens
5. Long-term consequences of antiretroviral agents on cardiovascular, renal, hepatic, and endocrine function, skin, gastrointestinal system and urogentital tract
6. Incidence of opportunistic infections or malignancy including hepatocarcinoma in patients with HIV/HCV or HIV/HBV co-infection
7. Immune recovery syndrome
8. Adherence to different antiretroviral regimens
9. Quality of life
To collect and evaluate long-term clinical outcomes of HIV infected participants previously enrolled in HIV-NAT trials.
Secondary Objective:
To Assess:
1. Long-term consequences of initiation of antiretroviral as predicted by baseline CD4 cell count and/or baseline plasma HIV RNA level
2. Incidence of lipodystrophy and other metabolic complications in three different groups of patients initially treated with NRTI-based regimens, NNRTI-based regimens, or PI-based regimens
3. Class-specific incidence of lipodystrophy and metabolic complications such as d4T versus AZT, nevirapine versus efavirenz and individual PIs (IDV, SQV, Kaletra, and atazanavir)
4. Resistance profiles in patients on different antiretroviral regimens
5. Long-term consequences of antiretroviral agents on cardiovascular, renal, hepatic, and endocrine function, skin, gastrointestinal system and urogentital tract
6. Incidence of opportunistic infections or malignancy including hepatocarcinoma in patients with HIV/HCV or HIV/HBV co-infection
7. Immune recovery syndrome
8. Adherence to different antiretroviral regimens
9. Quality of life
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
HIV Infections
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HIV infected patients( children and adults) previously participated HIV-NAT studies
* HIV infected patients( children and adults) currently participate in HIV-NAT trials
* Able to provide written consent
* HIV infected patients( children and adults) currently participate in HIV-NAT trials
* Able to provide written consent
Exclusion Criteria
* Unable to provide written consent
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The HIV Netherlands Australia Thailand Research Collaboration
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Praphan Phanuphak, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
HIV-NAT, Thai Red Cross AIDS Research Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
HIV-NAT, Thai Red Cross AIDS Research Center
Bangkok, , Thailand
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Thailand
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Law WP, Duncombe CJ, Mahanontharit A, Boyd MA, Ruxrungtham K, Lange JM, Phanuphak P, Cooper DA, Dore GJ. Impact of viral hepatitis co-infection on response to antiretroviral therapy and HIV disease progression in the HIV-NAT cohort. AIDS. 2004 May 21;18(8):1169-77. doi: 10.1097/00002030-200405210-00010.
Reference Type
RESULT
Law WP, Dore GJ, Duncombe CJ, Mahanontharit A, Boyd MA, Ruxrungtham K, Lange JM, Phanuphak P, Cooper DA. Risk of severe hepatotoxicity associated with antiretroviral therapy in the HIV-NAT Cohort, Thailand, 1996-2001. AIDS. 2003 Oct 17;17(15):2191-9. doi: 10.1097/00002030-200310170-00007.
Reference Type
RESULT
Avihingsanon A, Kerr SJ, Punyawudho B, van der Lugt J, Gorowara M, Ananworanich J, Lange JM, Cooper DA, Phanuphak P, Burger DM, Ruxrungtham K. Short communication: Aging not gender is associated with high atazanavir plasma concentrations in Asian HIV-infected patients. AIDS Res Hum Retroviruses. 2013 Dec;29(12):1541-6. doi: 10.1089/aid.2013.0069. Epub 2013 Oct 2.
Reference Type
RESULT
Clarke A, Kerr S, Honeybrook A, Cooper DA, Avihingsanon A, Duncombe C, Phanuphak P, Ruxrungtham K, Ananworanich J, Kaldor J. Adherence and Risk Behaviour in Patients with HIV Infection Receiving Antiretroviral Therapy in Bangkok. Open Virol J. 2012;6:23-8. doi: 10.2174/1874357901206010023. Epub 2012 Feb 24.
Reference Type
RESULT
Nuesch R, Srasuebkul P, Ananworanich J, Ruxrungtham K, Phanuphak P, Duncombe C; HIV-NAT Study Team. Monitoring the toxicity of antiretroviral therapy in resource limited settings: a prospective clinical trial cohort in Thailand. J Antimicrob Chemother. 2006 Sep;58(3):637-44. doi: 10.1093/jac/dkl313.
Reference Type
RESULT
Avihingsanon A, Tongkobpetch S, Kerr SJ, Punyawudho B, Suphapeetiporn K, Gorowara M, Ruxrungtham K, Shotelersuk V. Pharmacogenetic testing can identify patients taking atazanavir at risk for hyperbilirubinemia. J Acquir Immune Defic Syndr. 2015 May 1;69(1):e36-7. doi: 10.1097/QAI.0000000000000540. No abstract available.
Reference Type
RESULT
Kerr SJ, Punyawudho B, Thammajaruk N, Colbers A, Chaiyahong P, Phonphithak S, Sapsirisavat V, Ruxrungtham K, Burger DM, Avihingsanon A. Factors associated with daily tenofovir exposure in Thai subjects taking combination antiretroviral therapy. AIDS Res Hum Retroviruses. 2015 Apr;31(4):368-74. doi: 10.1089/AID.2014.0249. Epub 2014 Dec 17.
Reference Type
RESULT
Avihingsanon A, Ramautarsing RA, Suwanpimolkul G, Chetchotisakd P, Bowonwatanuwong C, Jirajariyavej S, Kantipong P, Tantipong H, Ohata JP, Suankratay C, Ruxrungtham K, Burger DM. Ergotism in Thailand caused by increased access to antiretroviral drugs: a global warning. Top Antivir Med. 2014 Jan;21(5):165-8.
Reference Type
RESULT
Avihingsanon A, Jitmitraparp S, Tangkijvanich P, Ramautarsing RA, Apornpong T, Jirajariyavej S, Putcharoen O, Treeprasertsuk S, Akkarathamrongsin S, Poovorawan Y, Matthews GV, Lange JM, Ruxrungtham K; HIV-NAT125 study team. Advanced liver fibrosis by transient elastography, fibrosis 4, and alanine aminotransferase/platelet ratio index among Asian hepatitis C with and without human immunodeficiency virus infection: role of vitamin D levels. J Gastroenterol Hepatol. 2014 Sep;29(9):1706-14. doi: 10.1111/jgh.12613.
Reference Type
RESULT
Wattanakul T, Avihingsanon A, Manosuthi W, Punyawudho B. Population pharmacokinetics of nevirapine in Thai HIV-infected patients. Antivir Ther. 2014;19(7):651-60. doi: 10.3851/IMP2741. Epub 2014 Feb 6.
Reference Type
RESULT
Durier N, Ananworanich J, Apornpong T, Ubolyam S, Kerr SJ, Mahanontharit A, Ferradini L, Ruxrungtham K, Avihingsanon A. Cytomegalovirus viremia in Thai HIV-infected patients on antiretroviral therapy: prevalence and associated mortality. Clin Infect Dis. 2013 Jul;57(1):147-55. doi: 10.1093/cid/cit173. Epub 2013 Mar 19.
Reference Type
RESULT
Praditpornsilpa K, Avihingsanon A, Chaiwatanarat T, Chaiyahong P, Wongsabut J, Ubolyam S, Chulakadabba A, Avihingsanon Y, Ruxrungtham K, Tunsanga K, Eiam-Ong S, Phanuphak P. Comparisons between validated estimated glomerular filtration rate equations and isotopic glomerular filtration rate in HIV patients. AIDS. 2012 Sep 10;26(14):1781-8. doi: 10.1097/QAD.0b013e328356480d.
Reference Type
RESULT
Kerr SJ, Duncombe C, Avihingsanon A, Ananworanich J, Boyd M, Sopa B, Medtech B, Chuenyam T, Cooper DA, Lange JM, Phanuphak P, Ruxrungtham K. Dyslipidemia in an Asian population after treatment for two years with protease inhibitor-containing regimens. J Int Assoc Physicians AIDS Care (Chic). 2007 Mar;6(1):36-46. doi: 10.1177/1545109706295946.
Reference Type
RESULT
Avihingsanon A, Avihingsanon Y, Darnpornprasert P, Kerr S, Ungsedhapand C, Duncombe C, Ubolyam S, Ruxrungtham K, Phanuphak P. High prevalence of indinavir-associated renal complications in Thai HIV-infected patients. J Med Assoc Thai. 2006 Aug;89 Suppl 2:S21-7.
Reference Type
RESULT
Gatechompol S, Lutter R, Vaz FM, Ubolyam S, Avihingsanon A, Kerr SJ, van Leth F, Cobelens F. The plasma kynurenine-to-tryptophan ratio as a biomarker of tuberculosis disease in people living with HIV on antiretroviral therapy: an exploratory nested case-control study. BMC Infect Dis. 2024 Apr 2;24(1):372. doi: 10.1186/s12879-024-09258-4.
Reference Type
DERIVED
Wattanachanya L, Sunthornyothin S, Apornpong T, Lwin HMS, Kerr S, Gatechompol S, Han WM, Wichiansan T, Siwamongsatham S, Chattranukulchai P, Chaiwatanarat T, Avihingsanon A; HIV-NAT 207/006 study team. Bone mineral density among virologically suppressed Asians older than 50 years old living with and without HIV: A cross-sectional study. PLoS One. 2022 Nov 21;17(11):e0277231. doi: 10.1371/journal.pone.0277231. eCollection 2022.
Reference Type
DERIVED
Gatechompol S, Avihingsanon A, Apornpong T, Han WM, Kerr SJ, Ruxrungtham K. Efficacy and improvement of lipid profile after switching to rilpivirine in resource limited setting: real life clinical practice. AIDS Res Ther. 2019 Apr 5;16(1):7. doi: 10.1186/s12981-019-0222-6.
Reference Type
DERIVED
Han WM, Apornpong T, Kerr SJ, Hiransuthikul A, Gatechompol S, Do T, Ruxrungtham K, Avihingsanon A. CD4/CD8 ratio normalization rates and low ratio as prognostic marker for non-AIDS defining events among long-term virologically suppressed people living with HIV. AIDS Res Ther. 2018 Sep 27;15(1):13. doi: 10.1186/s12981-018-0200-4.
Reference Type
DERIVED
Punyawudho B, Thammajaruk N, Thongpeang P, Matthews G, Lewin SR, Burger D, Ruxrungtham K, Avihingsanon A. Population pharmacokinetics of tenofovir in HIV/HBV co-infected patients. Int J Clin Pharmacol Ther. 2015 Nov;53(11):947-54. doi: 10.5414/CP202386.
Reference Type
DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
http://www.hivnat.org
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HIV-NAT 006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care
NCT01900080
UNKNOWN
NA
Assess the Downregulation of HIV-1 When Raltegravir is Added to a Virologically Suppressed HAART Regimen
NCT00738569
COMPLETED
NA
Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART
NCT05584397
ENROLLING_BY_INVITATION
A Pilot Study of Triple NtRTI/NsRTI Therapy in Antiretroviral Naive HIV-1 Infected Patients
NCT00199121
UNKNOWN
PHASE4
Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients
NCT00128908
TERMINATED
PHASE4
Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA)
NCT00573001
COMPLETED
PHASE3
Viral Suppression After Analytic Treatment Interruption in Thai Patients Who Initiated Highly Active Antiretroviral Therapy During Acute HIV Infection
NCT02614950
COMPLETED
NA
TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants
NCT00980538
ACTIVE_NOT_RECRUITING
PHASE3
Second-line Therapy Antiretroviral in Patients Who Failed Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) - Based Regimens
NCT00627055
COMPLETED
PHASE4
RAL+ATV/r in Comparison With TDF/FTC (or 3TC) +ATV/r in HIV Infected Patients
NCT01829802
UNKNOWN
PHASE4
Raltegravir Added to Stable HAART in HIV-1 Infected Subjects With Viral Suppression and Low CD4 Recovery
NCT00562510
TERMINATED
PHASE3
Immune and Viral Status of HIV-Infected Patients After Stopping Combination Antiretroviral Therapy
NCT00001899
COMPLETED
Immediate Versus Deferred Antiretroviral Therapy in HIV-infected Patients Presenting With Acute AIDS-defining Events
NCT01417949
COMPLETED
PHASE4
First in Human Study of TLC-ART 101 (ACTU 2001)
NCT05850728
COMPLETED
PHASE1
Dynamics of Drug Resistance-associated Mutations in HIV-1 DNA Reverse Transcriptase Clearance During Effective Antiretroviral Therapy
NCT04448158
COMPLETED
HIV-1 Infected Patients, Phase II Trial, Dual Combination Doravirine/Raltegravir Open Label
NCT04513626
RECRUITING
PHASE2
Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France
NCT06799338
RECRUITING
HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine
NCT00855413
TERMINATED
PHASE4
Third Line Highly Active Antiretroviral Therapy (HAART) in HIV-infected Children
NCT01225406
COMPLETED
Evaluation of Innovative Combinatorial stratégies of Anti-latency and Anti-immune Activation Drugs Targeting HIV Reservoir
NCT04741100
WITHDRAWN
Switching From PI to RALtegravir in HIV Stable Patients
NCT00528892
COMPLETED
PHASE3
Intermittent Therapy in HIV-1 Infected Patients With Successful Viral Suppression Under Highly Active Antiretroviral Therapy (HAART)
NCT00122551
TERMINATED
PHASE3
Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults
NCT02246998
COMPLETED
PHASE4
CD4 Cell Recovery in HIV-1 Patients Comparing 2 Treatment Regimes
NCT00966160
COMPLETED
PHASE3