Observational Cohort of HIV Infected Adults and Children in the PHPT Network Hospitals in Thailand

HIV Infections Clinical Trial

Official title:

Observational Cohort of HIV Infected Adults and Children in the PHPT Network Hospitals in Thailand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433030
• Other study ID #: PHPT-Cohort
• Status: Completed
• First received: February 8, 2007
• Last updated: March 16, 2018
• Start date: January 2007
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: Institut de Recherche pour le Developpement
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

As Thailand is rapidly expanding access to antiretroviral treatments under the universal health coverage system, it is crucial to document and learn from pilot antiretroviral treatment programs, in particular the medical outcomes and logistical, and organizational issues faced by hospital teams and patients in order to adapt the ARV delivery and monitoring system to various local settings.

Specific objectives

1. Analyze data collected in patients participating in the PHPT antiretroviral treatment program, in accordance to national and international guidelines, with no experimental interventions.

2. To determine factors associated with treatment outcome including immune status, virologic factors and antiretroviral drugs levels

3. To study the operational aspects of integrating comprehensive HIV care into the existing care system with regards to new activities generated at the hospital level (counseling, referral systems, biological monitoring), the impact on other health activities, mobilization of human and financial resources, affordability and sustainability.

The population of the study consists of approximately 2,000 consenting HIV-infected patients, including one-third of children, receiving HIV care as part of the GF-ATM or OXFAM Access to Antiretroviral programs, presenting at any of the PHPT network hospitals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2816
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Adults and children (children are defined as less than 18 years old) patients are eligible for the inclusion in the cohort if they meet all the following inclusion criteria:

• 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.

Exclusion Criteria:

• This is an observational study of an access to treatment program, therefore all patients who require treatment and are willing to be followed by the medical team and have their data collected can be enrolled in the study. The only exclusion criteria would be refusal to participate and the discontinuation criteria would be withdrawal of consent.

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Thailand	Bhumibol Adulyadej Hospital	Bangkok
Thailand	Nopparat Rajathanee Hospital	Bangkok
Thailand	Somdej Prapinklao Hospital	Bangkok
Thailand	Chacheongsao Hospital	Chachoengsao
Thailand	Prapokklao Hospital	Chanthaburi
Thailand	Chiang Kham Hospital	Chiang Kham	Phayao
Thailand	Chiangrai Prachanukroh Hospital	Chiang Rai	Chiangrai
Thailand	Chonburi Hospital	Chon Buri
Thailand	Doi Saket Hospital	Doi Saket	Chiang Mai
Thailand	Hat Yai Hospital	Hat Yai	Songkla
Thailand	Kalasin Hospital	Kalasin
Thailand	Phaholpolphayuhasena Hospital	Kanchanaburi
Thailand	Khon Kaen Hospital	Khon Kaen
Thailand	Regional Health Promotion Centre 6, Khon Kaen	Khon Kaen
Thailand	Kranuan Crown Prince Hospital	Kranuan	Khon Kaen
Thailand	Lampang Hospital	Lampang
Thailand	Lamphun Hospital	Lamphun
Thailand	Mae Chan Hospital	Mae Chan	Chiang Rai
Thailand	Mae on Hospital	Mae on	Chiang Mai
Thailand	Nakornping Hospital	Mae Rim	Chiang Mai
Thailand	Mae Sai Hospital	Mae Sai	Chiang Rai
Thailand	Mahasarakam Hospital	Maha Sarakham	Mahasarakam
Thailand	Nakhonpathom Hospital	Nakhon Pathom	Nakhonpathom
Thailand	Maharaj Nakornratchasrima Hospital	Nakhon Ratchasima
Thailand	Nong Khai Hospital	Nong Khai
Thailand	Pranangklao Hospital	Nonthaburi
Thailand	Phan Hospital	Phan	Chiang Rai
Thailand	Phayao Provincial Hospital	Phayao
Thailand	Buddhachinaraj Hospital	Phitsanulok
Thailand	Ratchaburi Hospital	Ratchaburi
Thailand	Rayong Hospital	Rayong
Thailand	Roi-et Hospital	Roi-et
Thailand	Samutprakarn Hospital	Samut Prakan
Thailand	Samutsakon Hospital	Samut Sakhon
Thailand	San Kamphaeng Hospital	San Kamphaeng	Chiang Mai
Thailand	Sanpatong Hospital	San Pa Tong	Chiang Mai
Thailand	San Sai Hospital	San Sai	Chiang Mai
Thailand	Somdej Pranangchao Sirikit Hospital	Sattahip	Chonburi

Sponsors (3)

Lead Sponsor	Collaborator
Institut de Recherche pour le Developpement	Global Fund, Ministry of Health, Thailand

Country where clinical trial is conducted

Thailand, 

References & Publications (21)

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 — View Citation

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 fac — View Citation

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 o — View Citation

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 surv — View Citation

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 cerv — View Citation

Duong T, Jourdain G, Ngo-Giang-Huong N, Le Cœur 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 — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

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 Preventio — View Citation

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 — View Citation

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. R — View Citation

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 — View Citation

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 afte — View Citation

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 Cœur S, Lallemant M, Capeau J, M — View Citation

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 Cœur S, Sirirungsi W, Lallemant M, McIntosh K, Jourdain G. Incidence of Tuberculosis and Associated M — View Citation

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 Cœur S, McIntosh K, Traisathit P, Jourdain G. Treatment Failure in HIV-Infected Childr — View Citation

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 Pharmaco — View Citation

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, Bunupu — View Citation

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 Dea — View Citation

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 — View Citation

* Note: There are 21 references in all — Click here to view all references

External Links

•   PHPT Antiretroviral Treatment Cohorts