ClinicalTrials.gg
RecruitingNCT00411983Updated Sep 17, 2026

A Long-term Follow-up of the HIV-NAT Cohort

An observational study in HIV Infections, sponsored by The HIV Netherlands Australia Thailand Research Collaboration. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by The HIV Netherlands Australia Thailand Research Collaboration · Observational

From the registry’s dates

  • Started Nov 2002; still recruiting 24 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 28 studies in HIV Infections by The HIV Netherlands Australia Thailand Research Collaboration — 1 open to participants now, 1 under way, none of them phase 3. HIV Infections · The HIV Netherlands Australia Thailand Research Collaboration.

Started
2002
the only one that year
Observational
9 of 28
1 open now
Registered
4th of 28
by date

Among the 28 studies in HIV Infections by The HIV Netherlands Australia Thailand Research Collaboration, this one is the only one that started in 2002, is one of 9 observational ones, and was the 4th registered.

HIV Infections

4,735 studies on the registry are indexed under HIV Infections; 245 are open to participants now.

Browse HIV Infections studies →

Open to participants now

1 of the 28 studies in HIV Infections by The HIV Netherlands Australia Thailand Research Collaboration is open now, in 1 country.

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 28 studies in HIV Infections by The HIV Netherlands Australia Thailand Research Collaboration, or all of them as a file.
02

Study summary

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.

Read the detailed description

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
03

Conditions studied

  • HIV Infections

Browse trials for

Keywords

  • chronic HIV infection
  • long term cohort of HIV infection
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All HIV infected adult patients from HIV-NAT.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Unable to provide written consent
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. HIV infection

    This cohort will collect various information such as but not limited to: comorbidity, mortality, cardiovascular, neurological clinical data, treatment history, serious adverse events, PBMCs, clinical outcomes, virological outcomes, resistance, failure, aging, other opportunistic infections, etc

    Time frame: 30 years

07

Study locations

1 of 1 sites recruiting
  • HIV-NAT, Thai Red Cross AIDS Research Center
    Bangkok, 10330, Thailand
    Recruiting
    • Praphan Phanuphak, MD, PhD · Principal investigator
08

References and documents

Publications

  • 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. PubMed 15166532 ↗
  • 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. PubMed 14523276 ↗
  • 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. PubMed 24088045 ↗
  • 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. PubMed 22423306 ↗
  • 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. PubMed 16895939 ↗
  • 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. PubMed 25622064 ↗
  • 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. PubMed 25384393 ↗
  • 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. PubMed 24531557 ↗
  • 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. PubMed 24730732 ↗
  • 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. PubMed 24504545 ↗
  • 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. PubMed 23511301 ↗
  • 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. PubMed 22713478 ↗
  • 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. PubMed 17329503 ↗
  • 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. PubMed 17044450 ↗
  • Amornritvanich P, Siwamogsatham S, Chattranukulchai P, Tumkosit M, Apornpong T, Lwin HMS, Hiranburana N, Jarusyingdumrong Y, Han WM, Kerr S, Avihingsanon A. Prognostic value of ankle-brachial index and cardio-ankle vascular index for mortality and cardiovascular events in older people with HIV on long-term ART. HIV Med. 2026 Aug;27(8):1277-1286. doi: 10.1111/hiv.70244. Epub 2026 Apr 23. PubMed 42026876 ↗
  • Apornpong T, Han WM, Hiransuthikul A, Lwin HMS, Hiranburana N, Ubolyam S, Kerr SJ, Woratanarat T, Avihingsanon A; HIV-NAT 006 and 207 study team. Frailty Transition Among Older Adults Living With HIV in Thailand: A 5-Year Longitudinal Study. J Int AIDS Soc. 2026 Apr;29(4):e70099. doi: 10.1002/jia2.70099. PubMed 41918468 ↗
  • 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. PubMed 38565993 ↗
  • 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. PubMed 36409740 ↗
  • 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. PubMed 30953533 ↗
  • 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. PubMed 30261902 ↗
  • 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. PubMed 26308175 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2002 (actual). Primary completion is estimated for Dec 2030, 337 months after the start.

Of 187 non-industry observational studies under HIV Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 337 months is above that.

Counting every sponsor, half of 201 studies reached it within 38 months; a quarter within 16 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2006
First posted
Dec 15, 2006
StartActual
Nov 2002
Primary completionEst.
Dec 2030
CompletionEst.
Dec 2030
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00411983
Lead sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Responsible party
Sponsor
First posted
Dec 15, 2006
Start date
Nov 2002
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Sep 17, 2026

Study contacts

Anchalee Avihingsanon, MD, PhD
Contact
anchalee.a@hivnat.org
66 2 2557334-5 ext. 107
Stephen Kerr, PhD
Contact
s.kerr@unsw.edu.au
66 2 2557334-5 ext. 138
Praphan Phanuphak, MD, PhD
principal investigator · HIV-NAT, Thai Red Cross AIDS Research Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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