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.

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

• 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 Ill). 2007 Mar;6(1):36-46.
• 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.
• 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.
• Boyd MA, Srasuebkul P, Khongphattanayothin M, Ruxrungtham K, Hassink EA, Duncombe CJ, Ubolyam S, Burger DM, Reiss P, Stek M Jr, Lange J, Cooper DA, Phanuphak P. Boosted versus unboosted indinavir with zidovudine and lamivudine in nucleoside pre-treated patients: a randomized, open-label trial with 112 weeks of follow-up (HIV-NAT 005). Antivir Ther. 2006;11(2):223-32.
• Boyd MA, Siangphoe U, Ruxrungtham K, Duncombe CJ, Stek M, Lange JM, Cooper DA, Phanuphak P. Indinavir/ritonavir 800/100 mg bid and efavirenz 600 mg qd in patients failing treatment with combination nucleoside reverse transcriptase inhibitors: 96-week outcomes of HIV-NAT 009. HIV Med. 2005 Nov;6(6):410-20.
• Pace C, Emanuel EJ, Chuenyam T, Duncombe C, Bebchuk JD, Wendler D, Tavel JA, McNay LA, Phanuphak P, Forster HP, Grady C. The quality of informed consent in a clinical research study in Thailand. IRB. 2005 Jan-Feb;27(1):9-17. No abstract available.
• Ananworanich J, Moor Z, Siangphoe U, Chan J, Cardiello P, Duncombe C, Phanuphak P, Ruxrungtham K, Lange J, Cooper DA. Incidence and risk factors for rash in Thai patients randomized to regimens with nevirapine, efavirenz or both drugs. AIDS. 2005 Jan 28;19(2):185-92.
• Duncombe C, Kerr SJ, Ruxrungtham K, Dore GJ, Law MG, Emery S, Lange JM, Phanuphak P, Cooper DA. HIV disease progression in a patient cohort treated via a clinical research network in a resource limited setting. AIDS. 2005 Jan 28;19(2):169-78.
• 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.
• 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.

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

Exclusion Criteria:

• Unable to provide written consent