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

Официальное название

A Long-term Follow-up Study for HIV-infected Individuals Who Have Participated in HIV-NAT Study Protocols

Обзор

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.

Подробное описание

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

Первичные конечные точки

• HIV infection [Срок оценки: 30 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Unable to provide written consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Таиланд · 1 центр

• HIV-NAT, Thai Red Cross AIDS Research Center — Bangkok

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 24531557

Идентификаторы

NCT: NCT00411983 · HIV-NAT 006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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