NCT00433030

Brief Summary

Since 2004, the Thai Ministry of Public Health has massively scaled up antiretroviral treatment programs to provide therapy to more than 80,000 patients with partial support of the Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM). As access to HIV care continues to expand under the universal health coverage system, it is important to document and analyze the efficacy, tolerance, toxicity and acceptability of antiretroviral therapy within pilot treatment programs, to provide evidence based feedback and recommendations to the national program and policy makers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,816

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

38 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2007

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

11.1 years

First QC Date

February 8, 2007

Last Update Submit

March 16, 2018

Conditions

HIV Infections

Keywords

Highly Active Antiretroviral TherapyHIV Viral loadHIV drug ResistanceThailand

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV-infected Adults and Children

You may qualify if:

  • Participation in the GFATM or Oxfam Access to Antiretroviral Programs
  • For adults, consent to have their clinical or biological data used for this research study, and willingness to be followed at one of the PHPT network hospitals. For children, caregiver's consent to participate, willingness to bring the child to the scheduled visits for the duration of the treatment, and to have the child's clinical or biological data used for this research study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Mae Chan Hospital

Mae Chan, Changwat Chiang Rai, Thailand

Location

Mae Sai Hospital

Mae Sai, Changwat Chiang Rai, Thailand

Location

Phan Hospital

Phan, Changwat Chiang Rai, Thailand

Location

Somdej Pranangchao Sirikit Hospital

Sattahip, Changwat Chon Buri, Thailand

Location

Kranuan Crown Prince Hospital

Kranuan, Changwat Khon Kaen, Thailand

Location

Chiang Kham Hospital

Chiang Kham, Changwat Phayao, Thailand

Location

Hat Yai Hospital

Hat Yai, Changwat Songkhla, Thailand

Location

Doi Saket Hospital

Doi Saket, Chiang Mai, Thailand

Location

Mae on Hospital

Mae On, Chiang Mai, Thailand

Location

Nakornping Hospital

Mae Rim, Chiang Mai, Thailand

Location

San Kamphaeng Hospital

San Kamphaeng, Chiang Mai, Thailand

Location

Sanpatong Hospital

San Pa Tong, Chiang Mai, 50120, Thailand

Location

San Sai Hospital

San Sai, Chiang Mai, Thailand

Location

Chiangrai Prachanukroh Hospital

Chiang Rai, Chiangrai, Thailand

Location

Mahasarakam Hospital

Maha Sarakham, Mahasarakam, Thailand

Location

Nakhonpathom Hospital

Nakhon Pathom, Nakhonpathom, Thailand

Location

Bhumibol Adulyadej Hospital

Bangkok, Thailand

Location

Nopparat Rajathanee Hospital

Bangkok, Thailand

Location

Somdej Prapinklao Hospital

Bangkok, Thailand

Location

Chacheongsao Hospital

Chachoengsao, Thailand

Location

Prapokklao Hospital

Chanthaburi, Thailand

Location

Chonburi Hospital

Chon Buri, Thailand

Location

Kalasin Hospital

Kalasin, Thailand

Location

Phaholpolphayuhasena Hospital

Kanchanaburi, Thailand

Location

Khon Kaen Hospital

Khon Kaen, Thailand

Location

Regional Health Promotion Centre 6, Khon Kaen

Khon Kaen, Thailand

Location

Lampang Hospital

Lampang, Thailand

Location

Lamphun Hospital

Lamphun, Thailand

Location

Samutprakarn Hospital

Mueang Samut Prakan, Thailand

Location

Maharaj Nakornratchasrima Hospital

Nakhon Ratchasima, Thailand

Location

Nong Khai Hospital

Nong Khai, Thailand

Location

Pranangklao Hospital

Nonthaburi, Thailand

Location

Phayao Provincial Hospital

Phayao, Thailand

Location

Buddhachinaraj Hospital

Phitsanulok, Thailand

Location

Ratchaburi Hospital

Ratchaburi, Thailand

Location

Rayong Hospital

Rayong, Thailand

Location

Roi-et Hospital

Roi Et, Thailand

Location

Samutsakon Hospital

Samut Sakhon, Thailand

Location

Related Publications (22)

  • Collins IJ, Jourdain G, Hansudewechakul R, Kanjanavanit S, Hongsiriwon S, Ngampiyasakul C, Sriminiphant S, Technakunakorn P, Ngo-Giang-Huong N, Duong T, Le Coeur S, Jaffar S, Lallemant M; Program for HIV Prevention and Treatment Study Team. Long-term survival of HIV-infected children receiving antiretroviral therapy in Thailand: a 5-year observational cohort study. Clin Infect Dis. 2010 Dec 15;51(12):1449-57. doi: 10.1086/657401. Epub 2010 Nov 5.

    PMID: 21054181RESULT

  • Ngo-Giang-Huong N, Jourdain G, Amzal B, Sang-a-gad P, Lertkoonalak R, Eiamsirikit N, Tansuphasawasdikul S, Buranawanitchakorn Y, Yutthakasemsunt N, Mekviwattanawong S, McIntosh K, Lallemant M; Program for HIV Prevention and Treatment (PHPT) study group. Resistance patterns selected by nevirapine vs. efavirenz in HIV-infected patients failing first-line antiretroviral treatment: a bayesian analysis. PLoS One. 2011;6(11):e27427. doi: 10.1371/journal.pone.0027427. Epub 2011 Nov 23.

    PMID: 22132100RESULT

  • Jourdain G, Wagner TA, Ngo-Giang-Huong N, Sirirungsi W, Klinbuayaem V, Fregonese F, Nantasen I, Techapornroong M, Halue G, Nilmanat A, Wittayapraparat P, Chalermpolprapa V, Pathipvanich P, Yuthavisuthi P, Frenkel LM, Lallemant M; Program for HIV Prevention and Treatment (PHPT) Study Group. Association between detection of HIV-1 DNA resistance mutations by a sensitive assay at initiation of antiretroviral therapy and virologic failure. Clin Infect Dis. 2010 May 15;50(10):1397-404. doi: 10.1086/652148.

    PMID: 20377404RESULT

  • Wagner TA, Kress CM, Beck I, Techapornroong M, Wittayapraparat P, Tansuphasawasdikul S, Jourdain G, Ngo-Giang-Huong N, Lallemant M, Frenkel LM. Detection of HIV-1 drug resistance in women following administration of a single dose of nevirapine: comparison of plasma RNA to cellular DNA by consensus sequencing and by oligonucleotide ligation assay. J Clin Microbiol. 2010 May;48(5):1555-61. doi: 10.1128/JCM.02062-09. Epub 2010 Feb 24.

    PMID: 20181911RESULT

  • Fregonese F, Collins IJ, Jourdain G, Lecoeur S, Cressey TR, Ngo-Giang-Houng N, Banchongkit S, Chutanunta A, Techapornroong M, Lallemant M; Program for HIV Prevention and Treatment Study Group. Predictors of 5-year mortality in HIV-infected adults starting highly active antiretroviral therapy in Thailand. J Acquir Immune Defic Syndr. 2012 May 1;60(1):91-8. doi: 10.1097/QAI.0b013e31824bd33f.

    PMID: 22293548RESULT

  • Duong T, Jourdain G, Ngo-Giang-Huong N, Le Coeur S, Kantipong P, Buranabanjasatean S, Leenasirimakul P, Ariyadej S, Tansuphasawasdikul S, Thongpaen S, Lallemant M; Program for HIV Prevention and Treatment Study Group. Laboratory and clinical predictors of disease progression following initiation of combination therapy in HIV-infected adults in Thailand. PLoS One. 2012;7(8):e43375. doi: 10.1371/journal.pone.0043375. Epub 2012 Aug 15.

    PMID: 22905264RESULT

  • Khamduang W, Gaudy-Graffin C, Ngo-Giang-Huong N, Jourdain G, Moreau A, Luekamlung N, Halue G, Buranawanitchakorn Y, Kunkongkapan S, Buranabanjasatean S, Lallemant M, Sirirungsi W, Goudeau A; Program for HIV Prevention and Treatment Study Group. Long-term hepatitis B virus (HBV) response to lamivudine-containing highly active antiretroviral therapy in HIV-HBV co-infected patients in Thailand. PLoS One. 2012;7(7):e42184. doi: 10.1371/journal.pone.0042184. Epub 2012 Jul 31.

    PMID: 22860080RESULT

  • Collins IJ, Cairns J, Jourdain G, Fregonese F, Nantarukchaikul M, Lertpienthum N, Wannarit P, Attavinijtrakarn P, Layangool P, Le Coeur S, Lallemant M; Program for HIV Prevention and Treatment (PHPT) study team. Hospitalization trends, costs, and risk factors in HIV-infected children on antiretroviral therapy. AIDS. 2012 Sep 24;26(15):1943-52. doi: 10.1097/QAD.0b013e328357f7b9.

    PMID: 22824633RESULT

  • Puthanakit T, Jourdain G, Hongsiriwon S, Suntarattiwong P, Chokephaibulkit K, Sirisanthana V, Kosalaraksa P, Petdachai W, Hansudewechakul R, Siangphoe U, Suwanlerk T, Ananworanich J; HIV-NAT 086Study Team. HIV-1 drug resistance mutations in children after failure of first-line nonnucleoside reverse transcriptase inhibitor-based antiretroviral therapy. HIV Med. 2010 Oct 1;11(9):565-72. doi: 10.1111/j.1468-1293.2010.00828.x. Epub 2010 Mar 25.

    PMID: 20345882RESULT

  • Sukasem C, Cressey TR, Prapaithong P, Tawon Y, Pasomsub E, Srichunrusami C, Jantararoungtong T, Lallement M, Chantratita W. Pharmacogenetic markers of CYP2B6 associated with efavirenz plasma concentrations in HIV-1 infected Thai adults. Br J Clin Pharmacol. 2012 Dec;74(6):1005-12. doi: 10.1111/j.1365-2125.2012.04288.x.

    PMID: 22471906RESULT

  • Puthanakit T, Jourdain G, Suntarattiwong P, Chokephaibulkit K, Siangphoe U, Suwanlerk T, Prasitsuebsai W, Sirisanthana V, Kosalaraksa P, Petdachai W, Hansudewechakul R, Waranawat N, Ananworanich J; HIV-NAT 086 study team. High virologic response rate after second-line boosted protease inhibitor-based antiretroviral therapy regimens in children from a resource limited setting. AIDS Res Ther. 2012 Jun 18;9(1):20. doi: 10.1186/1742-6405-9-20.

    PMID: 22709957RESULT

  • Collins I, Cairns J, Le Coeur S, Pagdi K, Ngampiyaskul C, Layangool P, Borkird T, Na-Rajsima S, Wanchaitanawong V, Jourdain G, Lallemant M. Five-year trends in antiretroviral usage and drug costs in HIV-infected children in Thailand. J Acquir Immune Defic Syndr. 2013 Sep 1;64(1):95-102. doi: 10.1097/QAI.0b013e318298a309.

    PMID: 23945253RESULT

  • Tang MW, Rhee SY, Bertagnolio S, Ford N, Holmes S, Sigaloff KC, Hamers RL, de Wit TF, Fleury HJ, Kanki PJ, Ruxrungtham K, Hawkins CA, Wallis CL, Stevens W, van Zyl GU, Manosuthi W, Hosseinipour MC, Ngo-Giang-Huong N, Belec L, Peeters M, Aghokeng A, Bunupuradah T, Burda S, Cane P, Cappelli G, Charpentier C, Dagnra AY, Deshpande AK, El-Katib Z, Eshleman SH, Fokam J, Gody JC, Katzenstein D, Koyalta DD, Kumwenda JJ, Lallemant M, Lynen L, Marconi VC, Margot NA, Moussa S, Ndung'u T, Nyambi PN, Orrell C, Schapiro JM, Schuurman R, Sirivichayakul S, Smith D, Zolfo M, Jordan MR, Shafer RW. Nucleoside reverse transcriptase inhibitor resistance mutations associated with first-line stavudine-containing antiretroviral therapy: programmatic implications for countries phasing out stavudine. J Infect Dis. 2013 Jun 15;207 Suppl 2(Suppl 2):S70-7. doi: 10.1093/infdis/jit114.

    PMID: 23687292RESULT

  • Collins IJ, Cairns J, Ngo-Giang-Huong N, Sirirungsi W, Leechanachai P, Le Coeur S, Samleerat T, Kamonpakorn N, Mekmullica J, Jourdain G, Lallemant M; Programme for HIV Prevention and Treatment Study Team. Cost-effectiveness of early infant HIV diagnosis of HIV-exposed infants and immediate antiretroviral therapy in HIV-infected children under 24 months in Thailand. PLoS One. 2014 Mar 14;9(3):e91004. doi: 10.1371/journal.pone.0091004. eCollection 2014.

    PMID: 24632750RESULT

  • Suaysod R, Ngo-Giang-Huong N, Salvadori N, Cressey TR, Kanjanavanit S, Techakunakorn P, Krikajornkitti S, Srirojana S, Laomanit L, Chalermpantmetagul S, Lallemant M, Le Coeur S, McIntosh K, Traisathit P, Jourdain G. Treatment Failure in HIV-Infected Children on Second-line Protease Inhibitor-Based Antiretroviral Therapy. Clin Infect Dis. 2015 Jul 1;61(1):95-101. doi: 10.1093/cid/civ271. Epub 2015 Apr 1.

    PMID: 25838288RESULT

  • Riyaten P, Salvadori N, Traisathit P, Ngo-Giang-Huong N, Cressey TR, Leenasirimakul P, Techapornroong M, Bowonwatanuwong C, Kantipong P, Nilmanat A, Yutthakasemsunt N, Chutanunta A, Thongpaen S, Klinbuayaem V, Decker L, Le Coeur S, Lallemant M, Capeau J, Mary JY, Jourdain G. New-Onset Diabetes and Antiretroviral Treatments in HIV-Infected Adults in Thailand. J Acquir Immune Defic Syndr. 2015 Aug 1;69(4):453-9. doi: 10.1097/QAI.0000000000000647.

    PMID: 25886928RESULT

  • Traisathit P, Delory T, Ngo-Giang-Huong N, Somsamai R, Techakunakorn P, Theansavettrakul S, Kanjanavanit S, Mekmullica J, Ngampiyaskul C, Na-Rajsima S, Lallemant M, Cressey TR, Jourdain G, Collins IJ, Le Coeur S. Brief Report: AIDS-Defining Events and Deaths in HIV-Infected Children and Adolescents on Antiretrovirals: A 14-Year Study in Thailand. J Acquir Immune Defic Syndr. 2018 Jan 1;77(1):17-22. doi: 10.1097/QAI.0000000000001571.

    PMID: 29040162RESULT

  • Delory T, Ngo-Giang-Huong N, Rangdaeng S, Chotivanich N, Limtrakul A, Putiyanun C, Suriyachai P, Matanasarawut W, Jarupanich T, Liampongsabuddhi P, Heard I, Jourdain G, Lallemant M, Le Coeur S; PapilloV study group. Human Papillomavirus infection and cervical lesions in HIV infected women on antiretroviral treatment in Thailand. J Infect. 2017 May;74(5):501-511. doi: 10.1016/j.jinf.2017.02.007. Epub 2017 Feb 28.

    PMID: 28254419RESULT

  • Salvadori N, Ngo-Giang-Huong N, Duclercq C, Kanjanavanit S, Ngampiyaskul C, Techakunakorn P, Puangsombat A, Figoni J, Mary JY, Collins IJ, Cressey TR, Le Coeur S, Sirirungsi W, Lallemant M, McIntosh K, Jourdain G. Incidence of Tuberculosis and Associated Mortality in a Cohort of Human Immunodeficiency Virus-Infected Children Initiating Antiretroviral Therapy. J Pediatric Infect Dis Soc. 2017 Jun 1;6(2):161-167. doi: 10.1093/jpids/piw090.

    PMID: 28204517RESULT

  • Homkham N, Cressey TR, Ingsrisawang L, Bouazza N, Ngampiyaskul C, Hongsiriwon S, Srirojana S, Kanjanavanit S, Bhakeecheep S, Coeur SL, Salvadori N, Treluyer JM, Jourdain G, Urien S. A Population Pharmacokinetic/Pharmacodynamic Model Predicts Favorable HDL Cholesterol Changes Over the First 5 Years in Children Treated With Current Efavirenz-Based Regimens. J Clin Pharmacol. 2016 Sep;56(9):1076-83. doi: 10.1002/jcph.701. Epub 2016 Feb 24.

    PMID: 26749102RESULT

  • European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) Study Group in EuroCoord. Safety of darunavir and atazanavir in HIV-infected children in Europe and Thailand. Antivir Ther. 2016;21(4):353-8. doi: 10.3851/IMP3008. Epub 2015 Nov 12.

    PMID: 26561496RESULT

  • Kawilapat S, Salvadori N, Ngo-Giang-Huong N, Decker L, Kanjanavanit S, Puangsombat A, Preedisripipat K, Lertpienthum N, Akarathum N, Mekmullica J, Srirompotong U, Lallemant M, Le Coeur S, Traisathit P, Leroi C, Jourdain G. Incidence and risk factors of loss to follow-up among HIV-infected children in an antiretroviral treatment program. PLoS One. 2019 Sep 17;14(9):e0222082. doi: 10.1371/journal.pone.0222082. eCollection 2019.

    PMID: 31527875DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Gonzague JOURDAIN, MD, PhD

    Institut de Recherche pour le Developpement

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

February 8, 2007

First Posted

February 9, 2007

Study Start

January 1, 2007

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

March 20, 2018

Record last verified: 2018-03

Locations

TH(38)